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POLITECNICO DI MILANO
Scuola di Architettura Urbanistica Ingegneria delle Costruzioni
Corso di laurea in Management of Built Environment
CLEANROOMS: PROPOSAL OF A TOOL FOR THE ANALYSIS OF
MAINTENANCE REQUIREMENTS AND CRITICALITIES
Relatore: Prof.ssa Cinzia TALAMO
Co-Relatore: Ing. Nazly ATTA
Tesi di laurea di:
Federica Bonomelli Matr. 834193
Anno accademico 2015/2016
I
Table of contents
List of tables ................................................................................................................... IV
List of figures ................................................................................................................. VI
Sommario ......................................................................................................................... 1
Abstract ............................................................................................................................. 2
Introduction ...................................................................................................................... 3
Theoretical Part................................................................................................................. 5
1. Cleanrooms ................................................................................................................... 5
1.1 Definition ................................................................................................................ 5
1.2 Design and construction .......................................................................................... 8
1.2.1 Product ............................................................................................................. 8
1.2.2 Classification .................................................................................................... 9
1.2.3 Typology of cleanrooms................................................................................. 11
1.2.4 Material of construction ................................................................................. 17
1.2.5 Surrounding environment ............................................................................... 20
2. Standards .................................................................................................................... 23
2.1 The engineering classes ........................................................................................ 23
2.1.1 Federal Standard 209 ...................................................................................... 23
2.1.2 ISO 14644 ...................................................................................................... 27
2.2 The biocontamination and pharmacy classes ........................................................ 30
2.2.1 EU GMP ......................................................................................................... 31
2.2.2 ISO 14648 ...................................................................................................... 33
3. Risks and Criticalities ................................................................................................. 35
3.1 ISO 9001 ............................................................................................................... 36
3.1.1 Risk-Based Thinking ...................................................................................... 38
3.1.2 PDCA ............................................................................................................. 38
II
3.2 ISO 31000 ............................................................................................................. 40
3.3 Sources of risk ...................................................................................................... 43
3.4 Risk Assessment ................................................................................................... 46
3.5 Monitoring Plan .................................................................................................... 51
4. Case Studies ................................................................................................................ 53
4.1 Mechanical Engineering Industry: Mako Shark S.r.l. .......................................... 53
4.1.1 The core business: composite materials ......................................................... 53
4.1.2 The cleanroom: ISO Class D .......................................................................... 57
4.1.3 The management of the cleanroom: in-house ................................................ 60
4.2 Pharmaceutical Industry: Aerosol Service Italiana S.r.l. ...................................... 61
4.2.1 The core business: pharmaceutical products .................................................. 62
4.2.2 The cleanrooms: ISO Class C ........................................................................ 64
4.2.3 The management of the cleanroom: outsourcing ........................................... 68
4.3 Case studies comparison ....................................................................................... 70
5. General cleanroom maintenance ................................................................................ 72
5.1 The market of cleanroom services ........................................................................ 73
5.2 The cleaning .......................................................................................................... 75
5.3 Cleanroom functional plans .................................................................................. 78
5.4 Maintenance requirements and criticalities .......................................................... 80
Proposal Part ................................................................................................................... 87
6. Proposal of a framework for identifying risk factors connected to maintenance activities
........................................................................................................................................ 87
7. Proposal of a framework for identifying risk factors connected to maintenance
activities: application to Mako Shark S.r.l. .................................................................... 89
7.1 Environmental units .............................................................................................. 89
7.2 Tasks and activities ............................................................................................... 90
III
7.3 Maintenance steps ................................................................................................. 91
7.4 Maintenance risk factors: the macro-contamination hazard ............................... 103
8. Proposal of a framework for identifying risks factors connected to maintenance
activities: application to Aerosol Service Italiana S.r.l. ............................................... 153
8.1 Environmental units ............................................................................................ 153
8.2 Tasks and activities ............................................................................................. 154
8.3 Maintenance steps ............................................................................................... 155
8.4 Maintenance risk factors: the micro-contamination hazard ................................ 168
9. Framework validation and outcomes ........................................................................ 232
9.1 Comparison between the case studies on the framework application................. 232
9.2 Outcomes of the application of the framework in the mechanical engineering sector
.................................................................................................................................. 234
9.3 Outcomes of the application of the framework in the pharmaceutical sector ..... 238
9.4 General outcomes of the framework application ................................................ 242
Conclusions .................................................................................................................. 245
Bibliography ................................................................................................................. 248
IV
List of tables
Table 1.1: Possible classification of cleanrooms for different type of product or process.
.......................................................................................................................................... 9
Table 1.2: US Federal Standard 209D Cleanroom Class Limits. ..................................... 9
Table 1.3: Airflow pattern, average velocities and air changes per hour data. .............. 17
Table 1.4: Cleanroom construction materials. ................................................................ 19
Table 2.1: Federal Standard 209E airborne particle cleanliness classes. ....................... 26
Table 2.2: ISO Classes of air cleanliness by particle concentration ............................... 29
Table 2.3: Intermediate decimal air cleanliness classes by particle concentration. ....... 29
Table 2.4: EU GMP Grades of air cleanliness for particle concentration. ..................... 32
Table 2.5: Comparison between EU GMP and UNI ISO 14644 cleanroom classification.
........................................................................................................................................ 32
Table 2.6: Recommended limits for microbial contamination. ...................................... 33
Table 3.1: Severity and likelihood 5x5 matrix. .............................................................. 49
Table 4.1: Mako Shark S.r.l. cleanroom characteristics. ................................................ 57
Table 4.2: Intermediate decimal air cleanliness class 8,5 by particle concentration. ..... 58
Table 4.3: Requirements and risks of the cleanroom of Mako Shark S.r.l. .................... 59
Table 4.4: Class D cleanroom characteristics. ................................................................ 64
Table 4.5: Air cleanliness class D by particle concentration. ......................................... 65
Table 4.6: Class C cleanroom characteristics. ................................................................ 65
Table 4.7: Air cleanliness class C by particle concentration. ......................................... 66
Table 4.8: Requirements and risks of the cleanroom of Aerosol Service Italiana S.r.l. . 68
Table 4.9: Comparison between Mako Shark S.r.l. and Aerosol Service Italiana S.r.l. on
cleanroom’s use. ............................................................................................................. 70
Table 4.10: Comparison between Mako Shark S.r.l. and Aerosol Service Italiana S.r.l. on
cleanroom’s structure. .................................................................................................... 71
Table 4.11: Comparison between Mako Shark S.r.l. and Aerosol Service Italiana S.r.l. on
cleanroom’s maintenance. .............................................................................................. 71
Table 5.1: General cleanroom requirements and criticalities. ........................................ 86
V
Table 7.1: Mako Shark S.r.l. environmental unit characteristics. .................................. 89
Table 7.2: Tasks and activities of Mako Shark S.r.l. maintenance. ............................... 91
Table 7.3: Mako Shark S.r.l. maintenance activities. ................................................... 102
Table 7.4: Mako Shark S.r.l. maintenance risks. .......................................................... 103
Table 7.5: Mako Shark S.r.l. framework application. .................................................. 152
Table 8.1: Aerosol Service Italiana S.r.l. environmental unit characteristics. ............. 154
Table 8.2: Tasks and activities of Aerosol Service Italiana S.r.l. maintenance. ........... 155
Table 8.3: Aerosol Service Italiana S.r.l. maintenance activities. ................................ 167
Table 8.4: Aerosol Service Italiana S.r.l. maintenance risks. ....................................... 169
Table 8.5: Aerosol Service Italiana S.r.l. framework application. ............................... 231
Table 9.1: Mako Shark S.r.l. cleanroom activity value. ............................................... 235
Table 9.2: Macro-contamination value for each maintenance activity. ....................... 236
Table 9.3: Maintenance activity value according to macro-contamination risk. .......... 237
Table 9.4: Final maintenance activity ranking. ............................................................ 237
Table 9.5: Number of steps performed in each environmental unit. ............................ 239
Table 9.6: Micro-contamination risk value for each environmental unit. .................... 239
Table 9.7: Environmental unit value according to micro-contamination risk. ............. 240
Table 9.8: Final environmental unit ranking. ............................................................... 240
VI
List of figures
Figure 1.1: Conventional airflow cleanroom. ................................................................. 11
Figure 1.2: Vertical unidirectional flow cleanroom. ...................................................... 14
Figure 1.3: Horizontal unidirectional flow cleanroom. .................................................. 14
Figure 1.4: Vertical airflow system. ............................................................................... 15
Figure 1.5: Horizontal airflow system. ........................................................................... 15
Figure 1.6: Mixed flow cleanroom ................................................................................. 16
Figure 1.7: Isolators. ....................................................................................................... 17
Figure 3.1: The Plan-Do-Check-Act model. .................................................................. 39
Figure 3.2: Principles, framework and process of ISO 31000........................................ 42
Figure 3.3: Questions for the risk identification. ............................................................ 48
Figure 4.1: Mako Shark S.r.l. cleanroom planimetry. .................................................... 58
Figure 4.2: Aerosol Service Italiana S.r.l. cleanroom planimetry. ................................. 66
Figure 5.1: Examples of cleanroom functional plans. .................................................... 79
Figure 7.1: Mako Shark S.r.l. functional plan. ............................................................... 90
Figure 8.1: Aerosol Service Italiana S.r.l. functional plan. .......................................... 154
Figure 9.1: Schema of the analysis ............................................................................... 238
Figure 9.2: Schema of the analysis. .............................................................................. 241
Figure 9.3: Application of the framework and adaptability of the outcomes. .............. 244
1
Sommario
La cleanroom o camera bianca, è, per definizione, un ambiente ad atmosfera controllata,
le cui caratteristiche in termini di umidità relativa, temperatura, pressione e inquinamento
particellare permettono la lavorabilità di determinati prodotti e l’esecuzione di alcune
parti di processo. Esistono, infatti, differenti settori che necessitano di eseguire la totale
o parziale produzione in questi ambienti sterili, i quali, prevenendo il rischio di
contaminazione del prodotto, assicurano il mantenimento delle condizioni lavorative
necessarie.
Data la complessità e i requisiti di questi ambienti, tenuto conto della diversità di
caratteristiche e necessità tra settore e settore, non è possibile definirne un’unica strategia
di gestione. Diventa necessario analizzare caso per caso, individuando specifici rischi e
necessità.
Il mantenimento di tutti i requisiti e la prevenzione dei rischi richiede un’attenta e
specifica gestione che può essere sviluppata tramite uno strumento comune di partenza,
con il quale poter analizzare e comprendere nel dettaglio requisiti e criticità.
Diventa necessario elaborare uno strumento d’analisi manutentiva di base, dal quale poi
sviluppare e approfondire ulteriori analisi, al fine di ottenere informazioni utili al
miglioramento e coordinamento delle attività manutentive.
Key words: Cleanroom, manutenzione, gestione, rischi, requisiti, criticità.
2
Abstract
The cleanroom or white room is, for definition, an atmosphere controlled environment,
which characteristics, in terms of relative humidity, temperature, pressure, and particulate
contamination, allows the workability of specific products and the execution of some
parts of the process. Indeed, exist several different sectors, which need to perform the
total or partial production in these sterile environments, which, preventing the
contamination risk of the product, ensure the maintenance of the necessary working
conditions.
Due to the complexity and the requirements of these environments, considered the
diversity of characteristics and requirements between sector and sector, it is not possible
to define a unique management strategy. It becomes necessary analyse case by case,
identifying specific risks and needs.
The maintenance of all requirements and the prevention of risks require a careful and
specific management, which can be developed through a common starting framework,
with which it is possible to analyse and understand in details all requirements and
criticalities.
It becomes necessary to develop a tool for the basilar maintenance analysis, from which
then develop and examine in depth further analysis, in order to obtain useful information
for the improvement and coordination of maintenance activities.
Key words: Cleanroom, maintenance, management, risks, requirements, criticalities.
3
Introduction
Main goal of this thesis is to analysis cleanroom maintenance, defining a tool to examine
requirements and criticalities. Cleanrooms, as controlled environments, have specific
needs to respect, to maintain the environmental conditions and ensure the workability of
the product.
Cleanroom conditions are defined by the product worked in it, which has characteristics
and needs to respect, in order to ensure its workability.
These controlled environments are complex area, which requirements include several
factors, starting from the structural needs, until the managerial one. Maintenance
organisation, on consequence, must be structured in order to ensure the fulfilment of
requirements and the conservation of environmental conditions. Due to the specificity
and complexity of cleanrooms, exists several criticalities, which can occur. These risks
can cause problems to the environment and to the production, compromising the product.
For this reason, it is necessary to identify them, in order to minimize and avoid any
problem.
To better analyse and develop this topic, it has been chosen to structure the analysis into
two main parts:
- Theoretical part, which aims is to analysis all cleanroom characteristics, starting
from the definition of the basic structural elements, until the definition of basic
maintenance requirements and criticalities;
- Proposal part, which aims is to provide a framework for maintenance
organisation, considering two case studies of cleanrooms, belonging to different
sectors.
The first chapter examines the basilar information of a cleanroom, as its structural and
technical characteristics, to understand and provide an overview of the argument. The
analysis proceeds with the second chapter, which aim is to define and explain all standards
that regard cleanroom. Third chapter focus the attention on risks, giving a definition of
them and providing a general overview of their typologies.
4
Chapter fourth, explain two case studies about two organisations of different sectors:
Mako Shark S.r.l., a mechanical engineering industry, and Aerosol Service Italiana S.r.l.,
a pharmaceutical one.
Fifth chapter illustrates basics concepts of cleanroom maintenance, focusing the attention
on general criticalities and requirements, and on the most important maintenance activity,
the cleaning.
With the sixth chapter starts the proposal part of the thesis. This part presents a general
description of the framework for the analysis of maintenance activities, which takes into
account possible risks and solutions. Then, the document proceeds with the seventh and
the eighth chapters, which illustrate the application of the tool to the two case studies
Ninth and last chapter presents all possible outcomes of the application of the framework,
in order to illustrate the functionality and applicability of the analysis to different typology
of cleanrooms, giving a concrete example of two possible different analysis of
maintenance.
Chapter 1
5
Theoretical Part
1. Cleanrooms
1.1 Definition
According to the International Organization for Standardization (ISO) standard 14644, a
cleanroom is a “room within which the number concentration of airborne particles is
controlled and classified, and which is designed, constructed and operated in a manner to
control the introduction, generation and retention of particles inside the room”.
At the same time, the US Federal Standard 209E defines a cleanroom as “a room in which
the concentration of airborne particles is controlled and which contains one or more clean
zones”.
As suggested by these definitions, a cleanroom is a room in which the introduction,
generation and retention of airborne particles is controlled and minimized in order to
obtain a clean area, indispensable in some industries. Indeed, many sectors require this
kind of space for the production of particular manufacturing processes to ensure the
quality and the un-contamination of the products, as:
- Semiconductors
- Pharmacy
- Aerospace
- Electronics
- Micromechanics
- Optics
- Biotechnology
- Hospital
- Food industry
This clean space is obtained through an efficient Heating, Ventilating and Air
Conditioning (HVAC) system, which supplies the cleanroom with large quantities of air
and allows to obtain an efficient control on the air flow. In fact, airborne particles and
Chapter 1
6
bacteria, brought by workers and equipment, are diluted and removed through air, which
allows to have the right pressurization of environments, preventing the flow of dirty air.
In addition, in order to ensure the efficiency, quality and feasibility of some
manufacturing processes, this controlled environment guarantees the control of
temperature, humidity, sound, light and vibration.
This particular and controlled space is designed in order to reach some specific objectives
as:
- The protection of the product to be realized;
- The control of the environment, in which the product has to be realized;
- The control of the personnel, who realize the product.
Indeed, cleanrooms are subjected to different sources of contamination as facilities,
equipment and people. These potential sources of contaminants can be divided into two
macro categories:
- External sources, constituted by external influence of gross atmospheric
contamination. These contaminates are brought primary by the air conditioning
system through makeup air, but they can also penetrate by building doors,
windows, crack and wall penetration for pipes, cables and ducts;
- Internal sources, found by people in the cleanroom, shedding of surfaces, process
equipment, equipment and the process itself.
According to the need of the manufacturing process and the method of ventilation, a
cleanroom can be divided into four main typologies:
- Conventional
- Unidirectional flow
- Mixed flow
- Isolators or minienvironment
The main features that differentiate a cleanroom from any other space are related to its
technical characteristics, its construction material, its management and maintenance.
Chapter 1
7
These elements are essential in order to maintain this special environment able to preserve
the characteristics needed by the process realized in it.
It is fundamental to understand that each cleanroom differs from the others because it is
designed and customized according to the product fabricated inside it. In fact, its
characteristics, the type of the manufacturing process and its particular needs are the
guidelines for the construction and the realization of a cleanroom. The only and most
important element, which characterize and distinguish in a formal way all the cleanrooms,
is their classification.
According to the different standards that regulate this field, cleanrooms are characterized
by classes, which indicate their cleanliness of air. Even if exist different type of classes,
all of them indicates the concentration of particles, measured in micron (µm), which is
one millionth of a metre. This concentration can vary, according to the contamination
level in a cleanroom, which depends on the particle generating activities going on in this
room. This means that in an empty room there will be a low particle concentration, while
in a room with a high production, the concentration will be much higher.
For this reason, the classification of a cleanroom must be carried out when the room is at
three different stages:
- As built, when the installation of the cleanroom is finished but there is no
production, equipment, materials, or workers;
- At rest, when the installation is finished, the cleanroom is equipped but there is
no personnel inside it;
- Operational, when the cleanroom is in functioning, with the equipment and the
personnel needed.
It is possible to define the class for the controlled environment by specific tests; during
the usage, the facility manager with the specific technicians periodically perform the right
tests, maintenance activities and monitoring, in order to ensure that the performance and
the standards of the cleanroom remain the same, avoiding any problem.
As it is possible to understand, a cleanroom is a complex environment in which it is
necessary to taking into consideration different elements, in order to ensure the continuity,
feasibility and quality of this area and the processes performed in it.
Chapter 1
8
To better understand all the aspects that have to be considered, it is important to go in
depth with some fundamental elements and discover all the basic information about
cleanrooms.
1.2 Design and construction
The most important elements that should be considered in the design and construction of
a cleanroom are the following:
- The product;
- The classification;
- The type of cleanroom;
- The material of construction;
- The surrounding environments
1.2.1 Product
First element to consider in the design of a cleanroom is the product. Cleanroom
characteristics depends on the product and its susceptibility to contamination. Indeed, the
object and its production process have specific characteristics and requirements, which
require its realization in a controlled environment, to ensure the respect of them.
According to this, is the task performed in a cleanroom which determines its class. The
following table shows the classification established by the Federal Standard 209, matched
with an example of possible typical products and sectors.
Class Product or Process
1 Integrated circuit manufactures manufacturing submicron geometries.
10 Semiconductor manufacturers producing integrated circuits with line widths
below 2 µm.
100 Used with a bacteria-free or particulate-free environment is required in the
manufacture of aseptically produced injectable medicines. Required also for
implant or transplant surgical operations.
1000 Manufacture of high quality optical equipment. Assembly and testing of precision
gyroscopes. Assembly and testing of precision gyroscopes. Assembly of
miniaturized bearings.
Chapter 1
9
10000 Assembly of precision of hydraulic or pneumatic equipment, servo-control valves,
precision timing devices, high-grade gearing.
100000 General optical work, assembly f electronic components, hydraulic and pneumatic
assembly.
Table 1.1: Possible classification of cleanrooms for different type of product or process.
Therefore, in order to establish and decide the class of a cleanroom, it is fundamental to
understand the requirements of the product and the condition necessary to perform in the
correct way its manufacturing process. For this reason, first it is important to take into
account the maximum allowed concentration of airborne particle. Then, after having
established the typology of process and the basic requirements, the decision of which
class is the most suitable for the designed cleanroom is taken by the producer. In fact,
does not exist any document or norm which give obligation about the number of class of
an industry, but only general guidelines about the design, control and test of cleanrooms.
1.2.2 Classification
As anticipated before, the cleanliness of their air classifies cleanrooms.
The first and most easily understood method is the one of the Federal Standard 209
version D, in which the classification of cleanrooms is made taking into account the
number of particles equal to and greater than 0,5 µm, measured in one cubic foot of air.
The following table shows the class limits:
Class Measured Particle Size (µm)
0.1 0.2 0.3 0.5 5.0
1 35 7.5 3 1 NA
10 350 75 30 10 NA
100 NA 750 300 100 NA
1000 NA NA NA 1000 7
10000 NA NA NA 10000 70
100000 NA NA NA 100000 7000
Table 1.2: US Federal Standard 209D Cleanroom Class Limits.
Then, in 1992, it has been published a new version of the Federal Standard, edition E,
which proposes a metric version in respect to the previous one. Due to its simplicity,
Chapter 1
10
Federal Standard 209 D has been used for many years and replaced only by the
International Standard Organization’s standard 14644-1.
The ISO standard 14644-1 illustrates the classification of cleanrooms starting from the
following equation:
Cn = 10N x [0.1
𝐷]2.08
Where:
- Cn represents the maximum allowed concentration, in particles/m3 of air, of
airborne particles that are equal to or larger than the considered particle size. Cn
is rounded to the nearest whole number;
- N indicates the ISO classification number, which have not to exceed the value of
9. There is the possibility to have intermediate ISO classification numbers, with
0.1 the smallest permitted increment of N;
- D is the considered particle size in µm;
- 0.1 is a constant with a dimension of µm.
This equation allows to determine the precise class limits for each cleanroom, which
corresponds to the maximum allowable airborne particle concentrations. In addition, the
ISO standard provides indications for the measurement and definition of cleanrooms that
need the count of ultrafine particles, smaller than 0.1 µm, and macro- particles, larger
than 5.0 µm.
It is fundamental to underline the element which direct influence the airborne
contamination level of a cleanroom: the particle-generating activities performed inside it.
Indeed, an empty area will have very low concentration of particles and the effect will be
a low level of contamination. On the contrary, a room full of equipment and personnel,
in a state of intense production, will have a higher concentration of airborne particle and
on consequence, higher level of air pollution. Due to the variability of these conditions, a
correct classification of a controlled environment must be carried out taking into
consideration three different occupancy states, defined by the ISO 14644-1 norm:
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11
- «As built: condition where the cleanroom or clean zone is complete with all
services connected and functioning but with no equipment, furniture, material or
personnel present»;
- «At-rest: condition where the cleanroom or clean zone is complete with
equipment installed and operating in a manner agreed upon, but with no personnel
present»;
- «Operational: agreed condition where the cleanroom or clean zone is functioning
in the specified manner, with equipment operating and with the specified number
of personnel present».
Further explanation on the method for the classification of a cleanroom, will be specified
in the second chapter.
1.2.3 Typology of cleanrooms
Once the class of the cleanroom has been defined and all the requirements of the product
and its process have been decided, it is possible to define the most appropriate ventilation
system.
The choice of the correct cleanroom has to be made between the following types:
A. Conventionally Ventilated Cleanrooms:
Figure 1.1: Conventional airflow cleanroom.
The image shows a conventional cleanroom, also defined as turbulently-ventilated or non-
unidirectional flow. The names derive from the fact that the air moves in a turbulent-
random way within the room. Indeed, an air conditioning plant supplies the air, through
Chapter 1
12
diffusers and filters installed in the ceiling. This type of cleanroom can achieve low
conditions, which corresponds to ISO Class 6 or, at least, ISO Class 7. The method used
is similar to other type of environment, with some significant differences:
- Air supply: the air changes rate per hour is 10 times more frequent in comparison
to a normal room, in order to ensure the low concentration of airborne particles.
As specified before, cleanrooms require large quantities of high standard air.
Indeed, for standard and economic reasons, it is fundamental that the air used
recirculates back through the air conditioning plant. At the same time, the system
has to consider the provision of fresh air for the operative workforce and for the
pressurization of the cleanroom against outside contamination. In respect to the
total air supplied, the percentage of fresh one varies between 2% and 10%.
The air change rate gives an indication about the level of cleanliness of the
cleanroom but for this type of controlled environment, this level is influenced by
two main factors: the first one is the volume of air supplied to the room in a given
time. The second one is the contamination generated by the equipment and
personnel working in the cleanroom.
The following equation express a way by which it is possible to find the desirable
level of cleanliness of a turbulently ventilated cleanroom:
𝐴𝑖𝑟𝑏𝑜𝑟𝑛𝑒 𝑐𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛 (𝑐𝑜𝑢𝑛𝑡
𝑚3 ) =𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑝𝑎𝑟𝑡𝑖𝑐𝑙𝑒𝑠 𝑜𝑟 𝑏𝑎𝑐𝑡𝑒𝑟𝑖𝑎 𝑔𝑒𝑛𝑒𝑟𝑎𝑡𝑒𝑑/𝑚𝑖𝑛
𝐴𝑖𝑟 𝑣𝑜𝑙𝑢𝑚𝑒 𝑠𝑢𝑝𝑝𝑙𝑖𝑒𝑑1 (𝑚3
𝑚𝑖𝑛)
This equation, joined with airborne dispersion rates, allows to estimate the likely
airborne quality. Despite, due to the fact that it is difficult to obtain data about the
particle dispersion from equipment and processes, the result will never be
accurate.
- Efficient filters: the filters of a cleanroom are much better than the one of a
standard room, with a capacity of remove particles 99,97% more efficient. The
filters used are of two types: High Efficiency Particle Air (HEPA) and Ultra Low
Penetration Air (ULPA). These filters usually are installed at the point where the
1 The air volume supplied includes that from unidirectional flow work station and benches.
Chapter 1
13
air is discharged into the room; the placement in a terminal position in the air
supply duct avoids the dispersion of particles through the air supply ducts, which
increase the air contamination.
- Terminal air filters: in order to minimise the draft generated by high air velocity
and create an environment with a good air mix, there is the application of air
diffusers, installed where the supply air enters in the cleanroom. The installation
of grills and diffusers is made at a low level around the walls, in order to avoid a
short-circuiting of air from the air supply and, on consequence, the no-recycling
of clean air.
- Room pressurization: to ensure that the contaminated air goes from the cleanroom
to the clean zones or adjacent areas, the flow of air has to move in the correct
direction. A high pressurization of this controlled environment, in respect to the
surrounding areas, allows that the flow of air moves from the cleaner area to the
less one, which on consequence have to be less pressurized. A correct
dimensioning requires a difference of pressures of 10 Pa between two cleanrooms
and about 15 Pa between a cleanroom and the surrounding clean zones. This
process can be obtained by extracting less air from the room than is supplied to it,
or by extracting the supplied air in adjacent areas.
B. Unidirectional Airflow Cleanrooms:
This kind of cleanroom, also known as “Laminar Flow”, corresponds to an environment
where the airflow follows one direction at a uniform speed throughout the entire space.
The choice of this ventilation system is required when there is the necessity to have low
airborne concentrations of particles or micro-organisms. The flow of air, which usually
have a speed between 0.3 and 0.5 m/s, can have two different directions:
Chapter 1
14
- Vertical unidirectional airflow
Figure 1.2: Vertical unidirectional flow cleanroom.
Image shows the typical configuration of a vertical airflow system, the most used type.
The air is supplied from the high efficiency filters positioned in the roof, then it flows
down through the entire cleanroom, removing the airborne contamination. At the end of
the flow, air exits through the floor or exhaust positioned in the walls and is mixed with
fresh air taken from outside in order to allow the recirculation through the system of
efficiency filters. This system operates in a proper manner if the cleanroom has a
maximum width of 6 meters. In fact, if the cleanroom is not properly designed, can
happen that the unidirectional flow does not totally cover the centre of the room. On
consequence, personnel and equipment situated in this area can be a possible source of
contamination.
- Horizontal unidirectional airflow
Figure 1.3: Horizontal unidirectional flow cleanroom.
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Image shows the configuration of the horizontal unidirectional air flow system. In respect
to the previous one, in this system the air starts his flow from one wall of the cleanroom
through high efficiency filters and crosses all the room until it arrives to the other wall.
Then it returns to a ventilation plant and back through the air filters.
This type of cleanroom is less used in respect to the vertical one due to the fact that the
risk of contamination is much higher.
The following images allow to make a comparison of the vertical and horizontal
configuration:
On the one hand, in the vertical airflow
system, the air dispersion is contained and
there is a better contamination control.
Figure 1.4: Vertical airflow system.
Indeed, on the other one, the problem in
the horizontal unidirectional system is
clear: the crossflow dispersion is greater
in respect to the down flow one and this
element generates a higher risk of
contamination.
Figure 1.5: Horizontal airflow system.
Despite that, the cleanliness and the control of airborne contamination of a unidirectional
airflow cleanroom is defined by the velocity of the air. In fact, in respect to a
conventionally ventilated cleanroom, the volume of air is from 10 to 100 times greater.
This velocity allows to obtain a better controlled environment because the speed of the
air can remove large particles before the contamination of the surfaces. This is the reason
this type of cleanroom can obtain a class ISO 6 or better.
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C. Mixed Flow Cleanrooms:
Figure 1.6: Mixed flow cleanroom.
This type of cleanroom, as its name suggests, is a mix of both the systems analysed before.
Indeed, the basic system, used for non-critical processes, is constituted by a conventional
flow, although, the critical manufacturing operations are carried out with a unidirectional
flow system, with higher air quality.
According to this principle, the system is constituted by an area, the less critical one,
where few filters are installed in the ceiling. Then, it is possible to identify the more
critical area, where the pattern of filters is more thick. In this configuration, air starts its
flow downward, over the critical zone, to then continue through the whole room. At the
end, the flow of air is conducted to the return grilles, in order to prevent the risk of
contamination.
D. Minienvironments or isolator:
This controlled environment is defined “isolator” in the pharmaceutical industry, while
the semiconductor one defines it “minienvironment”. The operating principle of this
cleanroom is based on walls of metal and plastic, which are used as barriers to isolate the
environment from airborne contamination. The air, filtered by high efficiency filters, is
sterile and pressurized, and allows to prevent the entry of outside contamination. The
personnel, in order to prevent the contamination, work in these areas entering into half
suits or using gauntlets. Products are introduced into these environments through a
sterilizing tunnel and then they are filled with liquid, inspected, freeze dried and capped
in the various isolator. The following image shows the typical configuration of isolators.
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Figure 1.7: Isolators.
After having identified the adequate ventilation system, it is necessary to define the proper
airflow pattern, average velocities, and air changes per hour, in order to establish and
maintain the required characteristics of the cleanroom. Does not exist a scientific method
to calculate these data, but the following table lists an example of them according to the
ventilation system and the cleanroom classification.
Cleanroom Class Ventilation System Average Airflow Velocity, fpm2 Air Changes/hour
1 Unidirectional 70-100 350-650
10 Unidirectional 60-110 300-600
100 Unidirectional 50-90 300-480
1000 Mixed 40-90 150-250
10000 Mixed 25-40 60-120
100000 Mixed 10-30 10-40
Table 1.3: Airflow pattern, average velocities and air changes per hour data.
1.2.4 Material of construction
Key element that distinguish a cleanroom from other type of areas is the material of
construction and finish. Indeed, materials have a great influence on the cleanliness of the
cleanroom and on the product realized in it. For this reason, it is very important that the
materials used in the construction of these controlled environment ensure to avoid the
2 FPM means Feet Per Minute and indicates the air velocity, which is measurement of the rate of displacement of air or gas at a specific location. 1 m/s equals 196.8503 ft/min.
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release of particles or bacteria. The following characteristics are considered fundamental
for these elements:
- Capacity to not generate particles;
- Capacity to be easily cleaned;
- Capacity to resist to water, detergents and disinfectants;
- Durability;
- Capacity to be chemically inert;
- Capacity to be antistatic;
- Capacity to have an airtight structure.
It is important that these listed properties will be maintained during the entire life of the
cleanroom, through maintenance activities and periodic controls.
Together with the material characteristics, it is necessary to consider the requirements for
a proper work place as, for example, suitable and comfortable surfaces and worktops,
presence of windows to allow the visibility from the work place to the outside areas or
presence of emergency exits.
In order to maintain the adequate and required level of cleanliness, it is important that the
cleanroom is positively pressurized in respect to the surrounding environment. For this
purpose, it is fundamental that the material of construction is smooth on the surface facing
the inside of the cleanroom. In addition, the surface has to be flat, without pores or break,
in order to prevent the deposit of any contaminate. Finally, another fundamental property
of these materials is the capacity to be waterproof. Indeed, penetration of water can
facilitate the growth of bacteria and micro-organisms.
These basic properties of cleanroom must conform to four requirements, which allow to
have high quality performances of these controlled environments:
- Functionality, the quality of having a practical use;
- Durability, the capacity to resist in time and to be maintained, repaired, or replaced
in case of necessity;
- Cleanability, the quality to be easily cleaned to prevent and avoid the risk of
contamination;
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- Maintainability; the ability to be maintained in order to restore the original
conditions.
These characteristics should be considered in the design of a cleanroom. The most used
construction techniques can be divided into two alternatives: the first one is the “in situ
construction”, which refers to a wet or dry construction with applied surface finish. The
second one is the “in situ assembly”, which takes into consideration a fully prefabricated
site-assembled system, constituted by pre-finished engineered components and modular
pre-finished composite panel system. In some cases, there is the possibility to combine
these two techniques, obtaining an “in situ assembly” for the construction of walls and
ceiling and an “in situ construction” for the realization of floors.
After having understood these basic elements, it is important to know which types of
materials can be used. The precondition, for the choice of the right materials, is that this
selection has to be made functionally to the level of protection required and the
performance criteria listed before.
The following table lists different typologies of construction materials, according to their
characteristic:
Characteristics Materials
Non-shedding - Stainless steel
- Powder-coated sheet metal
- Anodized aluminium
- Sealed concrete
- Plastic sheets
- Non-shrinking coatings of plastic
materials
- Ceramics
- Glass
Free of pores, unbroken, resistant to abrasion - Stainless steel surfaces
- Baked finishes
- Epoxy and resin paints ad finishes
- Ceramic surfaces
- Powder-coated finishes
- Sealed concrete
Easily cleanable - Smooth finished stainless steel
- Coated metal
- Anodized aluminium
- Plastic polymers
- Glass
- Smoot finished glazed tiles
Table 1.4: Cleanroom construction materials.
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According to the level of requirements needed and to the element that has to be realized,
the material can change. Usually, independently from general indications, each element
which compose the entire structure, has its own basic requirements. In fact, for example,
doors should have few horizontal surfaces, an electronic system to control the access and
have not to be sliding, in order to minimize the risk of contamination. Another example
can be the windows, which are constituted by a unique glass, without opening, with at
least three air chambers.
1.2.5 Surrounding environment
According to the ISO standard 14644-1, a clean zone is a “defined space within which
the number concentration of airborne particles is controlled and classified and which is
constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space”.
This definition indicates all spaces that are situated around the cleanroom, which are used
to bring materials inside the producing area, to allow personnel to change their clothes
and prepare to enter in the sterile area or to connect the different rooms inside the
cleanroom suite.
The number, dimension and properties of these areas can vary according to the different
requirements of the product and the production process, but for construction, these
environments are less pressurized in respect to the cleanroom, with a different control of
temperature and humidity.
1. Materials transfer area
This area allows to transport into the cleanroom all the materials needed in the
manufacturing process, maintaining a constant control of the contamination and of the
environment condition. This is allowed thanks to the use of an electronic system of doors,
which permits to open one door per time, in order to minimize the direct change of air
with the outside area and, on consequence, the entering of contaminated airflow.
Exists two different methods to transport materials inside a cleanroom: the first one
includes the use of a bench, which is used as partition between the cleanroom and the
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outside area. This method is used when the materials to be transported are small and easy
manageable. Before the transfer of the object, the surface of the bench is cleaned and
sterilized. In order to eliminate the contaminants coming from the outside environment,
the material package is removed and sometimes the content is sprayed with disinfectants.
Then, the carrier brings the material and make it pass through the air lock. Here, there is
a break during which the carrier has to leave the area and the airborne concentration
stabilizes. Only after that, personnel, operating in the cleanroom, can pick up the material.
This procedure allows to prevent airborne contamination and to maintain stable the
environment.
The second transportation method is without a bench. This is required when the object of
transportation has large dimension or is too heavy to permit a normal transport. The
procedure is similar to the one before, but instead of the transfer on the bench, a cart is
used to move the material. If the material is not too heavy, after the passage through the
airlock, the operating personnel can pick up the material and move it on an appropriate
cart. Otherwise, if the material is too heavy, the trolley, used to transport, it has to be
sterilized before enter into the clean zone, to allow to bring it also inside the cleanroom.
2. Clothing change area
The design of this room changes according to the different requirements, but usually it is
constituted by three different spaces. In order of disposition, the first one is the red room.
Here the personnel arrive and have to undress of their personal cloths and accessories,
which are contaminated by external bacteria. In addition, when required, workers have to
remove cosmetics. Then, they pass in the second area, the white one, in which they wear
the protections as masks for bear, a headdress, gloves, footwear coverings and a coverall.
This process can vary according to the class of the cleanroom. Indeed, low classes does
not require the complete change of clothes, but only some elements like the gloves and
the headdress. However, in high classes, with higher quality standards, personnel must
change completely their clothes. At the end, the last passage happens in the green room.
Here there are some special showers or washbasins, where workers have to pass in order
to complete the process of disinfection and minimize the risk of contamination in the
cleanroom. As for the other controlled environment, the doors are equipped with an
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electronic system, that interlocks the two doors, allowing the passage of dirty air. Usually,
this area for the change of personnel is designed also for visitors, who, before enter in a
cleanroom, have to wear some protections, in order to minimize the external
contamination. Usually, the organization provides specific procedures to lead personnel
in these processes, which require a high level of attention, to prevent and avoid any risk
of contamination.
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2. Standards
When designing a cleanroom, it is important to consider different factors, among which
several standards, guidelines, practices and recommendations, written by some national
standard organizations as the International Organization for Standardization (ISO),
General Services Administration (GSA) or Commission of the European Communities.
Cleanroom classification can be divided into two main groups:
- Engineering classes, based on inanimate particles air, as the Federal Standard 209;
- Pharmacy classes, used for hygienic production, as the Guides to Good
Manufacturing Practice;
All the standards following analysed taking into consideration the contamination
generated by airborne particles. As described before, the maximum allowed
concentration, in particles/m3 of air, depends on the type of cleanroom designed and, in
specific, on the type of product and manufacturing process carried out inside it. The
objective of these standards is to establish a method of classification for cleanrooms,
giving attention to different elements, as the test method for the particles count, the design
and construction factors, the precise terminology or all the correct procedures to work in
these controlled environments.
2.1 The engineering classes
This classification is usually used for cleanrooms in which electronic and engineering
products are manufactured. The base, from which derives this method of classification, is
the Federal Standard 209. Most of countries have adopted the same standard, while other
have decided to write their one national version, which is, in any case, based on the FE
209.
2.1.1 Federal Standard 209
Federal Standard 209 was published for the first time in 1963, with the title “Cleanroom
and Work Station Requirements, Controlled Environments”. Then it has been developed
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in the years, following different steps as edition A (1966), edition B (1973), edition C
(1987), edition D (1988) and finally edition E (1992).
At the beginning, this norm was not entirely mandatory, but was considered very useful,
since it helped and guided people in the design and construction of a cleanroom, giving
general information and rules.
The latest version is the E, titled “Airborne particulate cleanliness classes for cleanrooms
and clean zoned”. It is structured into the following sections:
1. Scope and limitations;
2. Referenced documents;
3. Definitions;
4. Airborne particulate cleanliness classes and U descriptors;
5. Verification and monitoring of airborne particulate cleanliness;
6. Recommendation for changes;
7. Conflict with referenced documents;
8. Federal agency interests.
In addition, it has several appendices:
A. Counting and sizing airborne particles using optical microscopy;
B. Operation of a discrete-particle counter;
C. Isokinetic and anisokinetic sampling;
D. Method for measuring the concentration of ultrafine particles;
E. Rationale for the statistical rules used in FED-STD-209E;
F. Sequential sampling: an optional method for verifying the compliance of air to the
limits of airborne particulate cleanliness classes M 2.5 and cleaner;
G. Source of supplemental information.
This norm defines the classification of cleanrooms as the logarithm of the airborne
concentration of particles ≥ 0.5 µm per m3. For example, a Class M4 room has a class
limit for particles ≥ 0.5 µm of 10000/ m3 and the logarithm of 10000 is 4, which
corresponds to the class. The following table shows the class limits of the cleanroom in
terms of particle concentration in metric unit.
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This federal standard has been cancelled in November 2001 by the IEST (Institute of
Environmental Sciences and Technology) Working Group and it has been superseded by
the ISO 14644, the new standard adopted until today for cleanrooms and other associated
controlled environments.
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Class Limits
0.1 µm 0.2 µm 0.3 µm 0.5 µm 5 µm
Class Name Volume Units Volume Units Volume Units Volume Units Volume Units
SI English (m3) (ft3) (m3) (ft3) (m3) (ft3) (m3) (ft3) (m3) (ft3)
M1 350 9.91 75.7 2.14 30.9 0.875 10.0 0.283 - -
M1.53 1 1240 35.0 265 7.50 106 3.00 35.3 1.00 - -
M2 3500 99.1 757 21.4 309 8.75 100 2.83 - -
M2.5 10 12400 350 2650 75.0 1060 30.0 353 10.0 - -
M3 35000 991 7570 214 3090 87.5 1000 28.3 - -
M3.5 100 - - 26500 750 10600 300 3530 100 - -
M4 - - 75700 2140 30900 875 10000 283 - -
M4.5 1000 - - - - - - 35300 1000 247 7.00
M5 - - - - - - 100000 2830 618 17.5
M5.5 10000 - - - - - - 353000 10000 2470 70.0
M6 - - - - - - 1000000 28300 6180 175
M6.5 100000 - - - - - - 3530000 100000 24700 700
M7 - - - - - - 10000000 283000 61800 1750
Table 2.1: Federal Standard 209E airborne particle cleanliness classes.
3 The class limits for intermediate classes are calculated using the following equation: particles/m3=10M(0.5/d)2.2, where M is the numerical designation of the class based on SI unit and d is the particle size in micrometres.
Chapter 2
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2.1.2 ISO 14644
The International Standard Organization 14644 standard has been written in 1999, with
the title “Cleanrooms and associated controlled environments”. The last and most updated
edition is the second, published on December 2015.
Ten parts compose this norm:
- 1: Classification of air cleanliness by particle concentration;
- 2: Monitoring to provide evidence of cleanroom performance related to air
cleanliness by particle concentration;
- 3: Test methods;
- 4: Design, construction and start-up;
- 5: Operations;
- 6: Vocabulary;
- 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-
environments);
- 8: Classification of air cleanliness by chemical concentration (ACC);
- 9: Classification of surface cleanliness by particle concentration;
- 10: Classification of surface cleanliness by chemical concentration.
The most important part is the first, where the norm explains the method for cleanroom
classification. This part can be divided into two sections: a normative part composed by
an introduction, which contains terms and definition of the cleanroom topic, the
classification and the demonstration of compliance. This part should be followed to be in
compliance with the norm. Then there is an informative one, which provides some
information that can be used in case of necessity.
After the first introductive and general part, the norm presents six attachments:
- Annex A (normative): Reference method for classification of air cleanliness by
particle concentration;
- Annex B (informative): Examples of classification calculations;
- Annex C (informative): Counting ad sizing of airborne macroparticles;
- Annex D (informative): Sequential sampling procedure;
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- Annex E (informative): Specification of intermediate decimal cleanness classes
and particle size thresholds;
- Annex F (informative): Test instruments.
Thus, the first part and the following three annexes are considered the normative section,
with which a cleanroom must comply. The most important element contained in this
chapter is the method for the definition of the class of a cleanroom.
The classification number is based on the following formula:
Cn = 10N x [0.1
𝐷]2.08
Where:
Cn represents the maximum allowed concentration, in particles/m3 of air, of airborne
particles that are equal to or larger than the considered particle size. Cn is rounded to the
nearest whole number;
N indicates the ISO classification number, which have not to exceed the value of 9. There
is the possibility to have intermediate ISO classification numbers, with 0.1 the smallest
permitted increment of N;
D is the considered particle size in µm;
0.1 is a constant with a dimension of µm.
The following table shows all the classes established through the above formula.
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ISO Class
number (N)
Maximum concentration limits (particles/m3 of air) for particles equal to and larger
than the considered sizes shown below4
0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm
Class 1 105 6 5 5 5 7
Class 2 100 244 104 5 5 6
Class 3 1000 237 102 354 5 6
Class 4 10000 2370 1020 352 834 6
Class 5 100000 23700 10200 3520 832 5, 6, 8
Class 6 1000000 237000 102000 35200 8320 293
Class 7 9 8 8 352000 83200 2930
Class 8 8 8 8 3520000 832000 29300
Class 910 8 8 8 35200000 8320000 293000
Table 2.2: ISO Classes of air cleanliness by particle concentration
In addition to this table, in the update of December 2015, the norm provides another
classification for the intermediate decimal cleanliness classes and particle size thresholds.
ISO Class
number (N)
Concentration of particles (particles/m3) 3
0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm
Class 1,5 324 5 5 5 5 6
Class 2,5 316 754 324 5 5 6
Class 3,5 3160 748 322 111 5 6
Class 4,5 31600 7480 3220 1110 263 6
Class 5,5 316000 74800 32200 11100 2630 6
Class 6,5 3160000 748000 322000 111000 26300 925
Class 7,5 8 8 8 1110000 263000 9250
Class 8,59 8 8 8 11100000 2630000 92500
Table 2.3: Intermediate decimal air cleanliness classes by particle concentration.
4 All concentration in the table are cumulative, this means that particle indicated include all particles equal to or greater than that size.
5 These concentrations will lead to large air simple volumes for classification. For this reason, it should be applied the sequential
sampling procedure described in Annex D of ISO 14644 norm.
6 Sampling and statistical limitations for particles in low concentrations make classification inappropriate
7 Sample collection limitations for both particles in low concentrations and sizes greater than 1 µm make classification at this particle
size inappropriate, due to potential particle losses in the sampling system.
8 To specify this particle size in association with ISO Class 5, the macroparticle descriptor M may be adapted and used in conjunction
with at least one other particle size. More information are contained in Annex C, section C.7.
9 Concentration limits are not applicable in this region of the table due to very high particle concentration.
10 This class is only applicable for the in-operation state.
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Then, the norm defines the nomenclature of a cleanroom which should consider the
following important elements:
- The classification number indicated as “Class ISO n”;
- The occupancy state11;
- The airborne particles diameter considered, calculated with the formula expressed
before.
2.2 The biocontamination and pharmacy classes
The pharmaceutical industry, around 1960, has been developed cleanroom standards to
tackle problems related to contamination, which caused several problems of sickness and
death.
The difference, in respect to the other industries, is that in the pharmaceutical sector is
fundamental to determine and ensure the sterility of the product, finding a correct method
to prevent the microbial and particle contamination.
According to this, it has been developed a standard, the Guides to Good Manufacturing
Practice, based on other engineering standards, as for example the FE 209 E. This guide
provides a clear method to design, manufacturing and plan a cleanroom for the
pharmaceutical sector.
This guide, as most of all other standards, is not mandatory but provides some
recommended requirements, which is appropriate follow, to better perform a specific
manufacturing process in the right environment. Each country, in the years, has embraced
the principles and requirements of this guide, interpreting its statement. Moreover, each
of them has constituted its own inspector, to ensure that the requirements of the normative
should be respected. According to this management, each producer has to comply with
the requirements of its own country and each pharmaceutical manufacturer should
comply with the guides of the countries receiving their products.
11 The occupancy state is defined by the ISO 14644-1 as: “As Built”, “At-rest”, “Operational”.
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In addition to them EU GMP norm, it is possible to find the UNI ISO 14648, which takes
into account the biocontamination control. The application of this norm is different in
respect to the EU GMP, due to their general application to the food, cosmetic or other
industries. Furthermore, this norm does not define any type of classification, but gives
indications about risk analysis, methods, and procedures.
2.2.1 EU GMP
The most used standard for the pharmaceutical sector was published in January 1997 and
it is titled “Volume 4 - European Union Guidelines to Good Manufacturing Practice –
Medicinal Products for Human and Veterinary Use – Annex 1 – Manufacture of Sterile
Medicinal Products”.
The objective of this document is to provides some guidelines in order to better manage
and design such environments in which sterile products are manufactured. Indeed, this
typology of product is subjected to special requirements to minimize the risks of
microbiological and of pyrogen12 contamination.
In respect to the UNI ISO 14644-1, cleanroom classification is based on four different
grades of air cleanliness, each of them defines the most appropriate environment for
specific operations:
- Grade A, which defines a local zone for high risk operations;
- Grade B, which indicates a zone for aseptic preparation and filling;
- Grade C and D, which defines clean areas for less critical operations.
In addition, the guide defines only two occupancy states:
- in operation, defined by the guide as “the condition where the installation is
functioning in the defined operating mode with the specific number of personnel
working”;
- at rest, defined by the norm as “the condition where the installation is installed
and operating, complete with production equipment but with no operating
personnel present”.
12 Pyrogen indicates a bacterium, any substance which can cause the fever.
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The definition of the maximum permitted airborne particle concentration for each grade
provides a clear distinction of these two condition. The limits allowed are shown in the
following table:
Maximum permitted number of particles per m3 equal to or greater than the
tabulated size
At rest In operation
Grade 0.5 µm 5.0 µm 0.5 µm 5.0 µm
A 3520 20 3520 20
B 3520 29 352000 2900
C 352000 2900 3520000 29000
D 3520000 29000 Not defined Not defined
Table 2.4: EU GMP Grades of air cleanliness for particle concentration.
In addition, the following table shows a comparison between the EU GMP and the UNI
ISO 14644, in order to match these two different types of cleanroom classification:
At rest In operation
EU GMP ISO
A 4,8 4,8
B 5 7
C 7 8
D 8 Not defined
Table 2.5: Comparison between EU GMP and UNI ISO 14644 cleanroom classification.
The guide gives an indication about the different types of operations that can be carried
out into the different Grades of air cleanliness. Operations are distinguished into two
different types, one relates to terminally sterilised products and the other to aseptic
preparations.
According to the different grades, the following list provides an example of
pharmaceutical operations for terminally sterilised products:
- Grade A: filling of products, when unusually at risk;
- Grade C: preparation of solutions, when usually at risk; filling of products;
- Grade D: preparation of solutions and components for subsequent filling.
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On contrary, this other following list gives some examples of pharmaceutical operations
for aseptic preparations:
- Grade A: aseptic preparation and filling;
- Grade C: preparation of solutions to be filtered;
- Grade D: handling of components after washing.
The production of aseptic preparation must be followed by a strict monitoring of them, in
order to prevent the microbial contamination. For this purpose, the norm requires the use
of some sampling methods, such as settle plates, volumetric air and surface sampling, that
should be used in operation condition, without interfere with the protection zone. The
guide gives some indications about the limits for microbiological monitoring of clean
areas, shown in the following table:
Recommended limits for microbial contamination13
Grade Air sample cfu/m3 Settle plates
(diameter 90
mm) cfu/4
hours14
Contact plates
(diameter 55mm)
cfu/plate
Glove print 5
fingers cfu/glove
A <1 <1 <1 <1
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -
Table 2.6: Recommended limits for microbial contamination.
2.2.2 ISO 14648
The International Standard Organization 14644 standard has been written in 2003 and
titles “Cleanrooms and associated controlled environments – Biocontamination control –
“.
Three main parts compose the norm:
- 1: General principle and methods;
- 2: Evaluation and interpretation of biocontamination data;
13 Values in the table are average values. 14 Individual settle plates may be exposed for less than 4 hours.
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- 3: Measurement of the Efficiency of Processes of Cleaning and/or Disinfection of
Inert Surfaces Bearing Biocontamination Wet Soiling or Biofilms.
The purpose of this norm is to provide a guide and a method for the evaluation of
microbiological hazards and the subsequent interpretation of the results. The norm
presents a formal system to identify potential hazards, their likelihood of occurrence, the
way to identify risk zones, establish a way to monitor and control them and finally find
potential corrective actions.
This first document provides a general part, in which it is possible to find all the
information related to the biocontamination control. Since a biocontamination takes into
account important risks and hazard that should be considered, evaluated and monitored,
the norm gives a guide to find the best risk management strategy, with all the possible
and basilar steps that should be followed.
In addition, the norm provides some informative annex:
- A: Guidance on determining airborne biocontamination;
- B: Guidance on validating air samplers;
- C: Guidance on determining biocontamination of surfaces;
- D: Guidance on determining biocontamination of textiles;
- E: Guidance on validating laundering processes;
- F: Guidance on determining biocontamination of liquids;
- G: Guidance on training.
The second part of the norm provides a detailed guide to evaluate the microbiological
data, obtained from sampling in specific risk zones in cleanrooms. At least, the third part
provides a guidance for a laboratory method for measuring the efficiency of cleaning an
inert15 surface.
15 An inert object is defined as a substance that is not chemically reactive.
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3. Risks and Criticalities
A risk is an effect of uncertainty on objectives16 and exists the likelihood of occurrence
of this risk, which can generate some potential events and consequences or a combination
of these.
Mathematically risk can be defined as the product of the probability that an event will
occur and the severity of the event itself. Reduce the risk means decrease undesired event
probability; to do this is fundamental know, analyse and outline every possible source of
risk.
A cleanroom, as a controlled environment, needs special and rigid controls to prevent any
type of risk, which can affect the product and its process. Indeed, exists different hazards
and in specific those which affect the product directly, and others which affect the space,
damaging indirectly it.
In order to prevent any dangerous situation, it is fundamental to recognize potential risks
and manage it in the most effective way, to avoid the interruption of the production
process. The recognition of risks can be done using some methods, as the Risk
Assessment or FMEA. Then it is important to make a constant and rigid control to monitor
the situation, with the help of a well-structured Monitoring Plan.
In addition to the cleanroom risk, it is important to manage all the hazardous that can
occur in the surrounding environment. For this reason, it is important to match and
manage in the best way all the monitoring actions, preventing all those situations that can
occur and which can cause criticalities in the process.
Due to the importance of risks and criticalities, and to create the best strategy to manage
them, it is fundamental to comply with the standards about risks, the UNI ISO 9001, and
the UNI ISO 31000.
16 Definition given by UNI ISO 31000.
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3.1 ISO 9001
The International Standard Organization 9001 standard has been written in 1987 and titles
“Quality management systems – Requirements”.
This norm is part of the UNI ISO 9000 family, composed by other two important norms:
- ISO 9000, “Quality management systems – Fundamentals and vocabulary”
- ISO 9004, “Managing for sustained success of an organization – A quality
management approach”
ISO 9001 is the only norm of this family with which a firm can be officially certified by
auditors of TÜV17 of Italy, while the others are only guides, helpful for the correct
interpretation of the principles of the quality system.
The main objective of this standard is to provide a method to create an adequate quality
management system, which helps organizations to improve their overall performances
and create basis for sustainable development initiatives.
Thanks to the last update of this standard, the fifth edition of September 2015, has been
introduced as mandatory the Risk Assessment, in order to oblige firms to take into
consideration all the possible risks that can have a direct influence on the processes.
Indeed, the paragraph 4.4, Quality management system and its processes, of the norm
explains:” The organization shall establish, implement, maintain and continually improve
a quality management system, including the processes needed and their interactions, in
accordance with the requirements of this International Standards. The organization shall
determine the processes needed for the quality management system and their application
throughout the organization and shall: (f) address the risks and opportunities as
determined in accordance with the requirements of 6.1”.
Proceeding, in paragraph 6.1, actions to address risks and opportunities, it is possible to
read: “When planning for the quality management system, the organization shall consider
the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks
ad opportunities that need to be addresses to:
17 Technischer Überwachungsverein, Associazione di Controllo Tecnico
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- Five assurance that the quality management system can achieve its intended
results;
- Enhance desirable effects;
- Prevent, or reduce, undesired effects;
- Achieve important improvement.”
Finally, in paragraph 6.1.2: “The organization shall plan:
- Actions to address these risks and opportunities;
- How to:
1) integrate and implement the actions into its quality management system
processes;
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential
impact on the conformity of products and services”.
These new parts of the norm make explicit the concept of risk, which can have two
different meaning. From one side, it is considered in order to take preventive actions to
avoid problems in the whole organization of the firm. From the other side, it assumes a
positive meaning, because the identification of a risk can lead to the recognition of an
opportunity.
According to this, it is important in the management of a quality system, to take into
consideration an approach based on the identification of risks, in order to reach some
objectives as:
- Improvement of the customer confidence and satisfaction;
- Assurance of the quality of goods and services;
- Establishment of a culture of prevention and improvement.
In addition, the norm introduces two important instruments, fundamental for the
management of risks:
- The Risk-Based Thinking
- The PDCA, Plan-Do-Check-Act
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3.1.1 Risk-Based Thinking
The Risk-Based Thinking is an action, which is made by everyone automatically or often
sub-consciously to get the best result. This action allows to include and consider the
concept of risk from the first time in the management system and then continually
improve and monitor it. Due to this, the management of risk becomes a preventive action,
part of strategic and operational planning.
In order to assume a Risk-Based Thinking, it is possible to follow these steps, adapting
them according to the needs of the organization and the objectives to achieve:
- Identify the risks;
- Prioritize the way in which the processes are managed;
- Balance risks and opportunities;
- Analyse and prioritize risks and opportunities;
- Plan actions to avoid, eliminate or mitigate the risks;
- Implement the plan taking the right actions;
- Check and monitor the effectiveness of the actions taken;
- Constantly improve the plan, keeping attention to possible changes.
The use of this technique ensures greater knowledge and awareness about risks and
opportunities of the organization, and improve the way to deal with them. In this way,
risks are not seen only as bad events, but can be transformed into opportunities and can
be managed by the whole organizations, in order to satisfy the proper needs and the one
of the customer.
However, it is important to highlight that this approach should be supported by a
technique in order to be really effective. For this purpose, UNI 9001 introduces the
PDCA.
3.1.2 PDCA
The Plan-Do-Check-Act is a methodology used to define, implement and control
corrective actions and improvements. It is also called Deming Cycle or Shewhart Cycle
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and it consists in a four-step model, a circle with no end that can be repeated again and
again for continuous improvement.
The following image shown the construction of the PDCA model:
Figure 3.1: The Plan-Do-Check-Act model.
The four steps are the following:
- Plan: identify and analyse the problem;
- Do: develop and test a possible and potential solution;
- Check: review the test, analyse the results, measure the effectiveness of the
solution, improving it where is necessary;
- Act: according to the results, choose if the solution is positive and works or in
alternative, restart the PDCA, searching new and better improvements.
This methodology can be daily used to find the right method to approach to a problem,
finding the proper solution. The four steps should be followed every time to ensure the
choice of the highest quality solution. The advantages of this technique are many as:
- The possibility to repeat several time the cycle, improving every time the solution;
- The possibility to reinforce and help other types of techniques usually used in the
management of problems, as the Kaizen or Continuous Improvement approaches;
- The possibility to find several solutions to different problems, testing them to find
the proper one;
- The possibility to avoid the waste of resources in the research of poor and
unsuitable solutions.
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The Risk Based Thinking and the Plan-Do-Check-Act techniques should be used
together, in order to get the best results in the management of risks. The union of these
actions is defined as Process Approach, a fundamental tool for an organization, in order
to manage activities, their relative problems and find solutions.
3.2 ISO 31000
The International Standard Organization 31000 standard has been written in 2009 and
titles “Risk management – Principles and guidelines”.
The scope of this norm is to provide a method to define and evaluate risks, which can
affect the processes and to define all possible solutions and interventions to prevent and
mitigate the potential effects of that risks. The aim is to assist organizations to integrate
the risk management in the overall management system, adapting the framework given
by the norm to their specific real needs.
The norm is structured in five main chapters:
1. Scope;
2. Terms and definitions;
3. Principles;
4. Framework;
5. Process.
The chapter 4, Framework, explains the management structure and give all the necessary
and basilar information to design and develop a proper management configuration,
according to the needs of the organization. The basis of the management technique is
founded on the PDCA model, which is used to manage and deal with risks.
The fifth chapter, Process, gives the guide lines in order to create the better management
system, in which the management of risk is perfectly integrated with the overall
management of the organization. In order to obtain a perfect integration, it is fundamental
that the process for the management of risk is used in every level and area of the
organization, starting from every single project and arriving to the risks related to the
environment. To be sure that this management works and creates benefits for the
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organization, it is important that every single possible risk will be analysed and managed
in the best way, for this purpose the most suitable model chosen is the PDCA.
The methodological approach presented by the norm is only a guide line which an
organization can chose to follow, to better perform its activity and the overall
management of the processes, the environment and the customers.
To complete the norm, exists the Annex A, “Attributes of enhanced risk management”,
which indicates all the characteristics which a proper management system should have.
The following image shows the principles, the framework and the process explained by
the norm to create and implement the most appropriate management system.
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Figure 3.2: Principles, framework and process of ISO 31000.
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3.3 Sources of risk
Risk is associated with the likelihood of an undesirable event occurring and the potential
effects the occurrence of that event have. It is important to identify a risk, define it and
decide the right action to take to face it. For this purpose, exists different ways and
methods to identify, prioritize and manage a risk, like the Risk Assessment and the
Monitoring Plan.
As explained in the first chapter, a cleanroom is a controlled environment, in which the
product fabricated in it plays the most important role. The environment, the equipment
and the personnel work in order to produce something which has not to be contaminated.
For this reason, it is very important to define the possible risks that can happen in a
cleanroom, defining the most appropriate method to manage them, without cause any
problem to the product and to the entire supply chain.
According to the type of manufacturing process and the product realized in a cleanroom,
risk can vary. Exists risks associated only to pharmaceutical products and other that can
commonly happen in every cleanroom. Due to the specificity of the risks, the objective is
to general categorize them and their causes, in order to simplify the recognition and
identification of these. The right management of risks associated to a cleanroom, due to
the particularity of this area and the greater risk for the product, is fundamental also to
match and manage, in the most proper way, all the risks of the entire organization.
Starting from the most general categorization of risks, it is possible to define:
- Accidentals risks: caused by unintentional actions, derived from carelessness,
negligence, lack of skills or other unintended causes;
- Intentional risks; caused by intentional actions.
In addition, this type of risks can be subdivided into:
- Recurrent risks: those risks which can occur in a continuous manner;
- Sporadic risks: those risks whose probability is very hard to estimate.
The occurrence of a risk can have a direct or indirect impact on different elements, as the
structure or the personnel, but most important is the impact that the product can suffer.
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All possible risks should correctly be identified and managed, starting from the definition
of the possible source of them.
Risks can derive from different sources that can be divided into:
A. External sources:
External sources of risks are those generated by the outside environment and which can
have an impact and dangerous consequences on the controlled environment itself. Indeed,
the area around a cleanroom is not a controlled space, and for this reason it has no
classification. Most of the time, the surrounding environment has characteristics
completely different from the classified cleanroom, and for this reason it can be a potential
source of risk.
The different controlled areas around the cleanroom, the material transfer and the clothing
change areas, have the function to protect and limit the entrance of any contaminants
inside the clean area. However, can happen that the conditions outside these environments
or other structural problems can anyway generate risks.
The most common risks, deriving from external sources, can be summarized as
unexpected change of environmental condition as temperature or humidity, caused by
natural or catastrophic events.
B. Human sources:
Human sources of risks are those deriving from the personnel, who is employed in the
realization of the product. Workers are identified as the first source of contamination in a
cleanroom, due to the fact that their movements and themselves generates micro and
macro airborne particles. For this purpose, exists some actions to prevent this type of
contamination, as for example the dressing procedure, carried out in the clothing change
area or some training procedures about the manufacturing processes.
Indeed, personnel, according to the type of product and its process, is trained to observe
and operate in the most appropriate manner, in order to ensure the correct execution of
the processes. These methods are at discretion of the organization, but are considered
fundamental to prevent any problem inside the supply chain.
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Despite, exists some risks related to human behaviour, which derive from:
- Few attention during the dressing procedure;
- Not good training or few attention in the application of it;
- Few attention during the execution of the manufacturing process;
- Bad use of the equipment or products;
- Few attention in the cleaning procedure of the cleanroom.
C. Environmental sources:
Environmental sources of risks are those deriving from the systems, the equipment and
the structure of the cleanroom. These elements are those which can generate most
frequently a risk and that can have the greater impact on the whole production.
Starting from the first element, the Heating Ventilating and Air Conditioning (HVAC)
system is the one which control and distribute the air in the cleanroom. As explained in
the first chapter, exist different type of controlled environment according to the type of
ventilation installed in it.
This system is constituted by a series of components, as filters and valves, which must be
periodically controlled to prevent any damage. In fact, a problem in the system can
compromise the ventilation in the cleanroom, causing an alteration of the temperature,
humidity or pressure of the environment, which has a direct and important influence on
the product. In specific, a correct use, cleaning and maintenance of all the filters allows
to ensure the right and necessary flow of air, which is fundamental to avoid the
contamination of airborne particles. The most frequent problems which can generate risks
are:
- Obstruction of filters or pipes;
- Break of filters, valves or pipes;
- Break of mechanical or electronic components;
- Insulation defects;
- Few attention in the cleaning procedures;
- General damages.
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The second environmental source of risk is the equipment installed in the cleanroom.
Every type of gear present in the controlled environment should be accurately analysed
and sterilised before entering in it. It is considered a good behaviour establish procedures
for the installation of equipment, which should provide the instruction for the sterilisation
of all elements. In addition, it is important to consider also the use of the equipment during
the production process. Any failure or non-correctly use of it can have a direct influence
to the product, generating a possible risk and contaminating it. Possible source of risk can
derive from:
- Few attention in the use;
- Break of components.
The last environmental source of risk is the structure, which include the cleanroom, the
material transfer area and the clothing change area. As explained in the first chapter, the
cleanroom is designed and constructed with specific materials and components, suitable
to be easily cleaned and to prevent the airborne particles contamination. Due to this, any
damage of the structure, as for example a crack in the floor on in the wall, constitutes the
suitable condition for the generation of contaminants, which have a direct influence on
the products.
Usually, due to the attention that requires this kind of structure, it is important to provide
constant controls and maintenance activities, to prevent any failure in the structure. The
most common problems that can generate a risk are:
- Cracks in the walls, floor or ceiling;
- Bad functioning of the doors or of their electronic systems;
- Loss of seals or silicone;
- Break of floor’s titles.
3.4 Risk Assessment
Risk assessment is a systematic process of identification of hazards and the analysis and
evaluation of risks associated with exposure of those hazards18.
18 UNI ISO 14644-2, “Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration”
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This process is important in the management of cleanroom risks in order to identify the
hazards, which can affect the performances of the area and the ability to maintain the
adequate characteristics of the environment as the air cleanliness. In addition, this
procedure allows to identify the parameters and requirements necessary to provide the
evidence of the cleanroom performances, used in the Monitoring Plan.
It is possible to define five main steps to perform a risk assessment:
1. Classification of work activities;
2. Identification of hazards;
3. Estimation of risks;
4. Evaluation of risks;
5. Records of risks.
1. Classification of work activities
The first important step regards the compilation of a list of all the work tasks involved in
the activity. To obtain an accurate list it is important to consider different elements as the
products that have to be produced, the activities that take place, the people involved in
these activities, the equipment used and the different areas in which these activities are
performed. It is important that this list is compiled in the most precise way, because every
work tasks could generate a risk which can compromise all the process and most of all
the product.
2. Identification of hazards
After having defined all possible work tasks, the second step regards the identification of
all possible hazards. The identification of a risk, for definition, is the process of
determining risks that could potentially prevent the program, enterprise or investment
from achieving its objectives. In order to better carry out this phase, it is important to
collect, elaborate and use all possible information about the work tasks to identify a
hazard. Information collected can be of different types, as historical data, theoretical
analysis, informed opinions or concerns of stakeholders. All data collected should be
analysed to find all possible problems that could be happen and the associated
consequences.
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To help the identification of risks, it can be useful to answer to some questions, thanks to
which is possible to better focus risks:
Figure 3.3: Questions for the risk identification.
After having defined these basic information, it is possible to continue the risk
assessment, following the third step.
3. Estimation of risks
This step concerns with the analysis of the possible risks identified, to estimate it. This
part of the process put in relation the likelihood of occurrence of the risk and the severity
of the harm.
In order to estimate a hazard, it is possible to use a matrix, which define some categories
for the likelihood of harm and some for the consequence of it.
The severity of harm can be classified according to five different levels, which have a
correspondent score:
- Minimal damage:1;
- Minor damage:2;
- Middle damage:3;
RiskSource ?
Where ?
When ?
How ?
Consequence ?
Minimizing capability
...
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- Major damage:4;
- Catastrophic damage:5.
This categorization describes the severity of the harm, starting from the less dangerous
consequence that it can generate, which have a less score, and arriving to the most
important one, which can bring important and irreparable consequences on the whole
process, and on consequence have the highest score.
As for the severity, also the likelihood has a scale of scores, subdivided into:
- Very unlikely: 1, which can occur at last once in the working life of an individual;
- Unlikely: 2, which can occur at least once every 5 years by an individual;
- Fairly unlikely: 3, which can occur at least once every 6 months by an individual.
- Likely: 4, which can occur at least once every 15 days by an individual;
- Very likely: 5, which can occur daily
After having decided the severity and likelihood scores for every hazard, it is possible to
continue the risk assessment.
4. Evaluation of risks
The objective of this step is to put in relation the likelihood of occurrence of the risk and
the severity of the harm. For this purpose, it is important to start with a 5x5 matrix, which
crosses and combines the different scores of severity and likelihood.
The matrix has the following structure:
Severity
Likelihood
First aid
injury
Minor injury “Three day”
injury
Major injury Fatality
1 2 3 4 5
Very likely 5 5 10 15 20 25
Fairly likely 4 4 8 12 16 20
Likely 3 3 6 9 12 15
Unlikely 2 2 4 6 8 10
Very unlikely 1 1 2 3 4 5
Table 3.1: Severity and likelihood 5x5 matrix.
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The constructed matrix is composed by values funded multiplying the likelihood with the
severity. Therefore, in order to prioritize risks, it is possible to combine the scores defined
in the previous step, and then find their value through the use of this matrix.
After having attributed a grade to each risk, it is possible to organize them in order of
priority. Indeed, as it possible to understand by the matrix below, every combination of
likelihood and severity has a colour, which determine the tolerance level of the risk.
It is possible to determine three level of tolerance of risk by the score:
- Acceptable risks: from 1 to 4 scores the risk is considered very low, green colour,
or low, light green;
- Tolerable risks: from 5 to 14 scores the risk is considered medium, yellow colour,
or medium, dark yellow;
- Unacceptable risks: from 15 to 25 scores the risk is considered high, red colour.
The score attributed to each risk allows to better understand its importance and to decide
the proper action to take in order to face it. The evaluation of the risk is totally dependent
from the choice of the decision maker, who attributes each score according to its
management. Due to this, the action taken are totally subjective and the matrix is only a
useful instrument to easily develop the risk assessment.
5. Record of risks
The last step of the risk assessment regards the record of all the hazards individuated in
the process. The registration of the risks identified must contain all fundamental
information about them, in order to be easily understandable. The basic information
which should be included regard:
- The type of risk;
- The likelihood;
- The severity;
- The subjects to be affected;
- The tolerance of the risk;
- The possible solution to prevent or face the risk.
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This document can be fundamental in the management process and must be continually
improved. Indeed, at the beginning of a process, the number of possible risks is very high,
due to the fact that there are not sufficient information about it. The preparation of a well-
structured risk assessment and a constant monitoring of the process allow to maintain the
control of the situation and collect sufficient information to better understand the
development of it. This method allows to continually improve the management of the
risks, developing a situation in which the number of risks is low and controlled through a
preventive management of the process.
In order to complete the management of risks, it is important to focus the attention to
another important tool, the Monitoring Plan, which allow to keep a constant control of
the situation.
3.5 Monitoring Plan
The UNI ISO 14644-2 defines the action of monitoring as “observations made by
measurement in accordance with a defined method and plan to provide evidence of the
performance of an installation”.
The monitoring plan is a useful technique to keep a constant control to the outputs of the
risk assessment. Due to the compilation of this plan, it is possible to improve the quality
of the performances and ensure high standards in the processes. Indeed, with the
monitoring of the situation, which considers all the possible risks identified in the risk
assessment, it is possible to avoid the non-compliance situations, ensuring the continuity
of the processes.
In the cleanrooms risk management, the monitoring plan is necessary to ensure that this
controlled environment is maintaining the required conditions to respect its ISO class.
Indeed, this plan should take into account all the outputs derived from the risks
assessment, to understand critical aspects and performances and carry out the right
monitoring actions to ensure that the performance required to the cleanroom must be
respected.
The compilation of this plan should be made after the writing of the risk assessment and
have to be constantly implemented and reviewed in order to consider all possible changes
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and updating of the process. In addition, a constant update of this procedure with possible
corrective actions allows to implement the management of the risks, increasing the quality
of the performances.
Concretely, an efficient monitoring plan has to contain the following data:
- A list of all the standard parameters, as temperature, humidity and pressure, to be
monitored;
- A list of all parameters, which can affect the airborne particle concentration and
can generate consequences on the product, to be monitored;
- A description of the measurement method used to monitor all the parameters;
- A description of the instruments used, with the related certificates of conformity,
the maintenance and calibration of them;
- A description and identification of the areas monitored;
- A list with all the limits for each parameter considered, with the connected
acceptance criteria or limit;
- A description of the actions to be taken in case of the exceeding of the acceptance
criteria;
- A list of need and frequency of the cleanroom classification in accordance with
the UNI ISO 14644-1;
- The format used to register and elaborate the data;
- The frequency for the updating of the monitoring plan.
All these requirements are suggested by the UNI ISO 14644-2, and for this reason are not
considered mandatory. Despite this, in order to obtain and efficient and adequate
management of all the possible risks of a cleanroom, it is deeply recommended to follow
these specifications.
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4. Case Studies
As anticipated in the first chapter, cleanrooms are controlled environments fundamental
to produce some products, which require a determinate level of sterility in order to be
fabricated. Exists some industries, in which the presence of a cleanroom is fundamental
for some manufacturing processes. In order to better understand the functioning of these
environments and the management system that each organization adopt to manage these
areas, is important to analyse concrete realities. In the following are presented two cases
studies, which belong to two completely different industries and thanks to which it is
clearly understandable how the product and its requirements can affect the design, the
risks, and the management of a cleanroom.
4.1 Mechanical Engineering Industry: Mako Shark S.r.l.
Mako Shark S.r.l. is a company specialized in the production of composite materials for
application in military, aeronautical and automotive, industrial and medical sectors.
This firm was started in 1985 for the manufacturing of fiberglass components of
motorcycles. In the years, the company has grown, specializing in third-party
manufacturing activities, using prepreg materials as carbon, glass and Kevlar.
Today, the company counts around 40 co-workers and covers a total area of 7000 sqm,
1800 sqm of which are covered by two adjacent production units.
4.1.1 The core business: composite materials
The core business of Mako Shark S.r.l. is production of components in composite
materials for third party. The strength of the company is the ability to manage the product
in all its phases, starting from the project, until the final production, dealing with the
realization of models, moulds and all the necessary equipment and process development.
One of the important characteristics that allowed this organization to develop a strong and
solidified business is the ability to manage and realize different projects, satisfying any
kind of client. Indeed, the capacity of the planning department, joined to the managerial
abilities learned during the years, has allowed the company to be opened to different
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markets and sectors, as aeronautical, medical, defence, automotive, industrial, furniture,
sportive and other branches. In addition, the collaboration with universities and the
participation of several research projects, allows the company to be constantly growing,
looking for innovation and research.
Other fundamental characteristic of the company is the choice of the raw materials
employed in the production. Composite materials are those elements consisting of two or
more components with different mechanical, physical and chemical properties and
distinct boundaries between the components19. This combination of elements allows to
obtain a composite material whose properties are different from those of the materials
that compose it.
The elements, which constitute these kind of materials, are:
- Reinforcing phase typically long or short fibres, as glass, carbon, and Kevlar;
- Matrices, typically polymeric resin, as polyester, phenolic, epoxy and polyimide.
Mako Shark S.r.l. experience and know how allows company to be very flexible in design
of products and processes with composite materials, finding the best solution for every
project. Composite materials require specific processes and design rules to be correctly
employed in the realization of every single project in order to achieve the real
performances and the advantages of this kind of materials.
It is important to understand the conformation and the manufacturing process of Mako
Shark S.r.l., to better understand its core business.
Product development starts from design department; first step, according with the
customer, is the requirements definition in term of geometry, mechanical performances,
mass, aesthetic finish. The design process includes 3D development, modelling, material
definition, structural analysis to arrive at the final product draws. After that, before the
starting of the production, occurs the process design, that depend otherwise on the
dimension, material, number of unit to produce, aesthetic finishing. Process design
19 Advanced Mechanics of Composite Materials, Valery V. Vasiliev & Evgeny V. Morozov
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include model, mould, and curing cycle development. Mould production can be
outsourced depending on the size and the materials required by the project.
After these initial phases, the production can start and can be subdivided in to the
following steps:
1. Pre-cutting and lamination;
2. Polymerization;
3. CNC finishing;
4. Manual finishing.
1. Pre-cutting and laminating: the raw materials employed have a limited life cycle due
to their polymerization, which depends on the temperature and on the firing time.
Materials are preserved in refrigerating rooms, in which are contained for at least 3
months at a temperature of -20°. When material is extracted from the freezers, it is
unpacked from the hermetic packaging, which is used to avoid the absorption of the
humidity. Then, material is transferred to the cleanroom, in which the necessary
temperature and humidity is maintained and it can be conserved until 10 days.
The pre-cutting phase consists in the preparation of the various layers of prepreg material
at the right dimension, according to its design, necessary to adapt these layers on the
moulds.
After having prepared all the necessary layers according to the ply book, the next step is
the lamination. This operation consists in to adhere to the mould the various layers
beforehand prepared, superimposing them. This phase is carried out by an operator by
hands in a cleanroom, in order to prevent any contamination of the product. This process
can be performed in one step or more step depending on the number of layer or the
introduction of different materials or cores. After that all the layer are laminated, a
vacuum bag must be realized before polymerization cycle. The mould is enveloped with
a nylon film and it is put vacuum-sealed; vacuum bag is used to pressure the composite
material on the mould, in order to grant compaction of layer. Vacuum bag usage increase
mechanical properties of the product for this reason is used for the mayor part of the
production.
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2. Polymerization: the second step of the manufacturing process consists in the curing of
the product. The mould, enveloped in the film, is put into an autoclave. The organization
is equipped with two autoclaves, the smallest one with a diameter of 1,5 meter and a
length of 3 meters; and another one, with a diameter of 2,5 meters and a length of 5 meters.
This machine allows to choose the pressure of the chamber, which corresponds to the
pressure of compaction of the product, the time-temperature steps, and the curing time.
According to the type of material employed, to the material of the mould and the different
characteristic required to obtain the final product, the operator sets all the data of the
autoclave and then the curing cycle can start. Once that the cycle is finished and the
autoclave is cooled, it is possible to extract the mould from the chamber. Then the
operator proceeds with the opening of the nylon packaging and with the detachment of
the product by the mould.
3. CNC finishing: after the extraction form the autoclave, the following phase consists in
the finishing of the product by CNC (Computer Numerical Control) machines. In fact,
due to the process and material characteristics each composite product needs some
operation as trimming or drilling.
Mako Shark S.r.l. is equipped with two 5-axis and two 3-axis, which allows to obtain an
accurate finishing of the product, complying with the tolerances defined by the projects,
according to the needs of the clients.
4. Manual finishing: the last step consists in the finishing of the product carried out
manually by operators. Using specific equipment, the personnel deal with the finishing
of the product, which consist also in bonding, bolting, painting and polishing of the final
output.
At the end of the manufacturing process, the final product is controlled and inspected by
the quality managers, before the shipping to the final client.
The core business of Mako Shark S.r.l. is not based on the mass production, but on a great
flexibility which allows to deal with any project and to find innovative ad custom-made
solutions. The manufacturing process explained is a general overview of the management
of the organization, in order to focus the attention on a specific phase of the process, the
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pre-cutting and lamination one, which is performed in a controlled environment, a
cleanroom.
4.1.2 The cleanroom: ISO Class D
Mako Shark S.r.l. has decided in 1998 to build a cleanroom in order to increase the quality
of product and satisfy the needs to work with composite materials. As explained before,
these kinds of materials require a specific temperature and humidity to be worked, due to
their limited life cycle related to these characteristics but also a low particles
concentration in order to not contaminate the resin and to guarantee a perfect cohesion of
the prepreg layers. According to this, the cleanroom has been constructed in order to
improve the manufacturing process of the organization, guaranteeing the best work
condition.
This cleanroom is a conventionally ventilated one. The air is supplied by an HVAC
system, positioned on the roof of the plant and arrives to the cleanroom, filtered by six
filters (highlighted by the green colour in the plant).
In the cleanroom, the equipment installed is the following:
- Two plotters, used for the pre-cutting of the materials;
- Three freezers, used for the conservation of the material near the workstations;
- Several mobile workstations.
The basic data of this cleanroom are the following:
Characteristics of cleanroom
Internal Surface 137 sqm
Supplied air flow capacity 2132 m3/h
Number of air changes 5,18 1/h
Minimum temperature
Minimum relative humidity
+18 °C
≤55%
Maximum temperature
Maximum relative humidity
+27 °C
≤55%
Table 4.1: Mako Shark S.r.l. cleanroom characteristics.
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According to ISO 14644 classification and to the last updated of the norm, the following
cleanroom belongs to ISO Class 8,5, which means that the concentration of particles
respects the following ranges:
ISO Class
number (N)
Concentration of particles (particles/m3)
0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm
Class 8,5 - - - 11100000 2630000 92500
Table 4.2: Intermediate decimal air cleanliness class 8,5 by particle concentration.
The following image illustrate the planimetry of the cleanroom:
Figure 4.1: Mako Shark S.r.l. cleanroom planimetry.
E.U.1 Cleanroom
E.U.2 Clothing
change area
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This cleanroom is designed according to the specific needs of Mako Shark S.r.l. The most
important elements to be considered are the temperature and humidity of this area, which
are constantly monitored. Also, particle concentration is an important parameter but due
to the difficult in real time monitoring this characteristic is periodical check. Indeed, any
significant variation of these characteristics, can cause damages, compromise the
workability, loss of the technical properties of the material to the composite materials
employed in the manufacturing process.
Another important element to be considered is the contamination of the product. As
explained in the previous chapters, a cleanroom, as a controlled environment, allows to
perform specific manufacturing processes, avoiding the contamination of the product. In
this specific case, it is not important the control of the micro-contamination of the product,
but the attention is focused on the macro one. For this reason, the organization does not
provide specific procedures for the entry and exit of materials and personnel. The workers
are required only to wear a headdress, gloves, and a coat, in order to prevent the macro-
contamination and, at the same time, to protect their self during the lamination phase.
In order to understand the management of the cleanroom and of its risks, adopted by the
organisation, the following table lists all the necessities and risks associated to this
cleanroom.
Requirements Risks
Humidity control
Temperature control
Macro-contamination control
Damages to the material / personnel
Damages to the material / personnel
Damages to the material
Table 4.3: Requirements and risks of the cleanroom of Mako Shark S.r.l.
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4.1.3 The management of the cleanroom: in-house
Mako Shark S.r.l. has decided to adopt the following strategy for the management of its
cleanroom.
- Ordinary maintenance:
The ordinary maintenance is organized and planned using a maintenance program. The
responsible operator performs every activity, beyond the work time, in order to avoid the
interruption of the processes.
The ordinary maintenance concerns the following activities:
- Daily cleaning;
- Periodic control of filters;
- Periodic control of the structure (doors, floor, lights);
- Control of the HVAC system.
- Extraordinary maintenance:
All activities that regard the extraordinary maintenance are outsourced. The maintenance
that regards the structure is performed by the same organization, who provided the
construction of the cleanroom. The main activities are related to the renovation of floors,
walls, windows, and doors.
At the same time, the extraordinary maintenance related to the HVAC system is
outsourced and performed by the manufacturing company.
- Qualification of the cleanroom according to UNI 14644:
Mako Shark S.r.l., recently, has decided to completely outsourced the management of the
qualification of the cleanroom. One time per year, an external company, specialized in
certification, carries out the qualification of the cleanroom according to the ISO
classification, performing the necessary tests and controls and determining the right class
for the cleanroom. This operation provides the evidence of the class of the cleanroom,
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defining possible improvement actions in order to be in compliance with the requisite of
the norm.
- Management of risks:
the production manager, in collaboration with an external consultant, constantly performs
the management of the risk. The organisation, according to its needs, has adopted a
specific format for this management, due to the fact the production of this firm is a process
with a high level of risks. The raw materials employed, the equipment used and the
processes performed to realize the final outputs present several risks for the product itself
and for the personnel.
The management of the risks related to the entire manufacturing process is joined with
the possible risks presented in the cleanroom. Humidity and temperature, the most
significant parameters of these environment, are constantly controlled by a specific
software, which daily register all data. Associated to this software, it has been installed a
panel of alarms, which shows the parameters of the cleanroom and, in case of significant
variations, notifies them through a sound alarm.
Most of these risks can affect the materials employed in the production, and on
consequence the final product. Risks related to the personnel depend, form the most, by
the controlled environment. Indeed, significant variation of the humidity or of
temperature, especially form the area outside the cleanroom and the controlled
environment itself, can affect the health of the operators, causing problems to the whole
process.
4.2 Pharmaceutical Industry: Aerosol Service Italiana S.r.l.
Aerosol Service Italiana S.r.l., started in 1968, is a company specialised in the production
of cosmetics, pharmaceuticals, medical devices, and medical surgical devices on behalf
of a third party.
The company is constantly growing, developing systems, equipment, and the departments
in order to improve its manufacturing processes, in compliance with norms and quality
certification.
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The organisation covers an area of 14.500 sqm and counts more than 120 employees.
4.2.1 The core business: pharmaceutical products
The production of the company is focused on three main sectors, cosmetic,
pharmaceutical and medical devices one.
As a pharmaceutical company, Aerosol Service Italiana S.r.l. has to be in compliance with
different norms, due to the particularity of its products. Indeed, the firm takes attention to
the quality of its products and to the environment in which the processes take place, in
order to reach the best quality for the product and for its clients.
As firm who works for third party, the production process consists in the preparation of
pharmaceutical and cosmetic products and in the consequent preparation of the final
packaging of the products.
Due to the different processes and their variety, it has been chosen to focus the attention
on the pharmaceutical sector, in order to analyse, in the following chapter, the different
cleanrooms of the company.
The production process can be divided in the following steps:
1. Preparation phase;
2. Admixture phase;
3. Replenishment phase;
4. Packaging phase.
The company receives the raw materials, stocked in specific sterilised containers, and
they are stocked in the different warehouses. These areas are constantly controlled
through an electronic system, which registers, every day, the data related to temperature
and humidity. Indeed, all products and materials worked in the pharmaceutical sector
need to be constantly controlled. Any variation in the parameters of the environment or
any contamination can damage the product, causing a consequently damage of the final
product.
1. Preparation phase: the first step of the manufacturing process refers to the preparation
of the raw materials. Stocked materials are collected by the warehouse and brought to the
Weighing Room, an isolator area, where materials are weighted and prepared under a
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hood. Here, an operator, wearing the proper protections, as i.e. gloves, a half mask and a
suite, weighs raw materials in specific environmental conditions, under a hood, in order
to maintain the parameters of the product controlled, avoiding any risk of contamination,
which can compromise the workability of the product.
2. Admixture phase: the second phase of the process consists in the preparation of the raw
materials, beforehand weighted. This process is performed in the Preparation Room, an
isolator area, in which materials are prepared and mixed in order to obtain the final
product. As the previous phase, an operator, in a sterilised and controlled environment,
wearing the proper protection, prepares the final product, which will subsequently put in
its case.
3. Replenishment phase: this phase consists in the puffiness of the case with the relatively
final product. This part of the process is performed combining the materials previously
prepared, with gas or alcohol, according to the different final product to be obtained. Due
to the particularity of the process, the organisation has provided a strict management of
the possible risks, which can not only damage the final product, but which are dangerous
in general.
4. Packaging phase: the last phase consists in the packaging of the final product before its
shipping. Here, the final product is assembled, i.e. in case of sprays, packaged and
branded with the specific lot number and expiry date, in according to the pharmaceutical
norms. These phase, as the previous ones, are performed in different cleanrooms, in order
to maintain a controlled temperature and humidity of the work environment, avoiding any
risk of contamination of the final product.
At the end of the production process, material is stocked in the specific warehouse before
the shipping phase. Due to the particularity of this sector, any lot of material produced is
submitted to different controls. The organisation is constantly controlled by AIFA20
agency, which occupies to control any lot of material and its relative process, in order to
reduce the risk related to production process. In addition, Aerosol Service Italiana S.r.l.,
as pharmaceutical industry, complies with different norms of the sector and in specific to
20 Agenzia Italiana del Farmaco
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the GMP21 norm, which regulates the production processes of pharmaceutical
components.
4.2.2 The cleanrooms: ISO Class C
The company is equipped with four different cleanrooms of different classes and
typologies, in order to ensure the quality of the products realized, minimizing risk of
contamination. Most of the phases of the production process are performed in cleanrooms,
which allow to maintain the control of the product ad its characteristics.
The first two phase of the process, the Preparation and Admixture phases, are performed
in Isolator environments, in which personnel work under hoods. These controlled
environments have a surface of 40 sqm respectively and are served by an UTA22 system
dedicated. This system ensures a constant control of humidity and temperature and it is
equipped with high efficiency filters, in order to guarantee the required sterility level.
In order to illustrate different typologies of cleanrooms, the following table summarizes
the principal characteristics of Admixture cleanroom:
Characteristics of class D cleanroom
Internal Surface 32.02 sqm
Material transfer area 6.14 sqm
Clothing change area 1.85 sqm
Supplied air flow capacity 4000 m3/h
Exhausted air flow capacity 3100 m3/h
Replacement air flow capacity 4000 m3/h
Minimum temperature
Minimum relative humidity
+18 °C
40%
Maximum temperature
Maximum relative humidity
+24 °C
65%
Table 4.4: Class D cleanroom characteristics.
This isolator environment is designed according to the principles of the GMP norm, and
it belongs to the following class:
21 Good Manufacturing Practices. 22 Air Treatment Unit.
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Table 4.5: Air cleanliness class D by particle concentration.
Class D, as explained in the second chapter, refers to the GMP norm, and corresponds to
class 8 of the ISO 14644, at rest condition.
The other phases of the process are performed in two other cleanrooms, which have
respectively class C and D. In the following it has been chosen to analyse the controlled
environment with class C.
In this type of cleanroom, the organisation performs the Replenishment and Packaging
phases. These steps of the process are realized in two different areas, and cover a total
surface of 84 sqm. The relative HAVC systems are positioned on the roof due to their
dimension and to their easier accessibility, which allows the necessary maintainability.
The products realized in this controlled environment require a higher level of sterility
than the others, and for this reason the concentration of airflow particles permitted is
lower than in the other cleanrooms.
The following table details the characteristics of this area:
Characteristics of the class C cleanroom
Replenishment area surface 37 sqm
Packaging area surface 46,7 sqm
Clothing change area and Material transfer area 19.5 sqm
Supplied air flow capacity 7270 m3/h
Replacement air flow capacity 2340 m3/h
External project conditions
Summer Temperature and Relative humidity
Winter Temperature and Relative humidity
+32 °C – 50%
-6 °C - 50%
Internal project conditions
Summer Temperature and Relative humidity
Winter Temperature and Relative humidity
+24 °C – 50%
+ 20 °C - 50%
Table 4.6: Class C cleanroom characteristics.
Maximum permitted number of particles per m3 equal to or greater than the
tabulated size
At rest In operation
Grade 0.5 µm 5.0 µm 0.5 µm 5.0 µm
D 3520000 29000 Not defined Not defined
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This type of cleanroom, according to EU GMP norm, belongs to class C, and has the
following characteristics:
Maximum permitted number of particles per m3 equal to or greater than the
tabulated size
At rest In operation
Grade 0.5 µm 5.0 µm 0.5 µm 5.0 µm
C 352000 2900 3520000 29000
Table 4.7: Air cleanliness class C by particle concentration.
For what concerns the ISO 14644, class C of the GMP norm corresponds to the class 7.
The following image illustrate an exemplifying planimetry of Aerosol Service Italiana
S.r.l. cleanroom.
Figure 4.2: Aerosol Service Italiana S.r.l. cleanroom planimetry.
E.U.1 Cleanroom E.U.3 Material
transfer area
E.U.2 Clothing
change area
E.U.4 Storage room
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Aerosol Service Italiana S.r.l. has designed and developed a management system in order
to continually monitor the condition of the cleanrooms, avoiding any possible risk. In
addition, the organisation has trained all the personnel involved with specific procedure
to control and register the most important environmental parameters.
Indeed, any area of the firm is equipped with Magnehelic, a pressure gauge which
indicates the temperature and humidity of the area. Before the start of the production, the
procedure provides that the operator writes in a pre-compilated format, called Logbook,
the data about the internal conditions of the cleanroom. In case of any variation, which
exceeds the required work condition of the area, the operator must warn the supervisors,
who have to act in order to solve the problem, avoiding a downtime of the production.
As cleanrooms, all other parts of the firm are constantly controlled by a system of
electronic devices, which register all the necessary environmental parameters. These data
are daily elaborated using a specific software, and then analysed. This procedure allows
to monitor the final product during all the production process and also when it is stocked
in the warehouse, before the shipping phase. Any variation of the parameters, which is
considered significant and dangerous for the product, has to be analysed and resolved.
This kind of control on the product is considered fundamental in a pharmaceutical
industry, where the final product needs specific condition to be worked. The organisation
is continually monitored by the external responsible organisations, as AIFA, and should
comply with different pharmaceutical norms, in order to produce high quality products.
The procedure adopted by the organisation are decided according to the needs of the
product; personnel is trained in order to ensure the respect and the right execution of the
processes. The particularity of the product realized and the work conditions required by
the product itself have established the guidelines for the design of the organisation
cleanrooms.
The following table illustrates all requirements and risks associated with the product,
which have driven the design of these environments:
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Requirements Risks
Humidity control
Temperature control
Micro-contamination control
Sterility control
Damages to the product / personnel
Damages to the product / personnel
Damages to the product
Damages to the product
Table 4.8: Requirements and risks of the cleanroom of Aerosol Service Italiana S.r.l.
4.2.3 The management of the cleanroom: outsourcing
Aerosol Service Italiana S.r.l. has decided to adopt the following strategy for the
management of its cleanrooms.
- Ordinary maintenance:
The ordinary maintenance is managed in two different way. For what concerns the
ordinary cleaning, the organisation, according to the principles of the norms, has adopted
an internal procedure. Indeed, trained personnel, using specific products and equipment,
perform the cleaning of the different controlled environments. This maintenance can be
divided into three different steps:
- Daily cleaning, which consists in the basic cleaning of the environments;
- Weekly cleaning, which consists in a more complete cleaning of the floor and the
environments;
- Monthly cleaning; which consists in the entire sterilization of floors and walls;
- End of production cleaning, which is performed when the production of a lot ends
and begins the production of a different product.
The ordinary maintenance, which consists in the control of the structure, the systems, and
the renovation of the structure, is performed by the producer firm of the cleanroom.
Indeed, due to the particularity of the processes and the high quality required in this sector
Aerosol Service Italiana S.r.l. has chosen to outsource all the maintenance. This choice
guarantees the organisation to maintain in the most proper way the structure, ensuring a
higher quality of the environments, systems and on consequence of the final product.
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Besides the routine controls on the structures to prevent and avoid any problem on the
production, the external firm, two times per year, renovates all the cleanrooms,
refurbishing the entire environments and the surrounding areas.
At the same time, ordinary maintenance related to the HVAC systems is outsourced. The
organisation carries out the routine controls on the different systems, keeping a constant
control. Indeed, a specific electronic system signals any damage on the structure. This
management is considered fundamental in this organisation, due to the fact that any
damage to the system can cause a variation of the environmental conditions. Significant
variations can cause a damage on the product or a downtime of the entire production.
- Extraordinary maintenance:
Extraordinary maintenance is managed in the same way of the ordinary one. In case of
problems, trained personnel of the organisation intervene in order to evaluate the situation
and localize the malfunction. After that, the responsible opens the procedure for the
extraordinary maintenance and call the relative producer.
Aerosol Service Italiana S.r.l. has decide to manage maintenance activities outsourcing
them. Due to the variety of maintenance activities and the attention that these
environments require, the company has draft an annual tender with the outsourced firms.
This contract details the different ordinary maintenance activities that the producer
companies have to perform during the year, according to the needs of the client.
- Qualification of the cleanrooms according to EU GMP norm and ISO 14644:
The classification of the cleanroom is performed by the engineering department of
Aerosol Service Italiana S.r.l. Indeed, the organisation has qualified and trained
engineers, who, with the specific equipment, perform every year all the necessary tests in
order to define the quality of the environments and their classification. The company, at
the same time, is constantly under the control of the national pharmaceutical institution,
which periodically require reports and data about all the production.
- Management of risks:
Risk presented in a pharmaceutical industry can be different, and their management is
complex. Raw materials used during the production can be dangerous, and any damages
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that can occur can cause problems to the structure and to the final product. For this reason,
Aerosol Service Italiana S.r.l has adopted a method to manage risks connected to the
product, to the entire structure, to the systems and to the cleanrooms. The system adopted
consists in the prioritization of risks according to the Risk Matrix. After the identification
of the possible risks, source of risks and their consequences, the company drafts a Risk
assessment, in order to guarantee a constant control of them. This document is constantly
updated according to the needs of the company and to the continuous improvements
derived by the risks occurred during the years. In addition, this management of risks
allows to reduce the probability of occurrence of them, avoiding damages on the final
product.
4.3 Case studies comparison
The two companies analysed, Mako Shark S.r.l. and Aerosol Service Italiana S.r.l., are an
example of how the management of a cleanroom can vary. Indeed, the type of production,
the needs of the manufacturing process and the products itself, are key factors, which
influence the design of a cleanroom.
A difference between these two companies to highlight is the way in which their
cleanrooms, of the same ISO class, differs in use, structure, and maintenance.
Cleanroom’s use:
Mako Shark S.r.l. Aerosol Service Italiana S.r.l.
The cleanroom of the firm is positioned at the
beginning of the manufacturing process. In this
controlled environment are performed some of the
most important phases of the process. The raw
materials used can be worked only under specific
environmental characteristics, guaranteed, in this
case, by the cleanroom. The cleanroom allows to
have a constantly control of temperature, humidity,
and macro-contamination.
Most of the phases of this organisation are
performed in cleanrooms. Indeed, the firm
operates in the pharmaceutical sector, which, due
to the particularity of the product, requires
controlled and sterilised environments. These
areas allow to have a constant control on
temperature, humidity, and micro-contamination.
Table 4.9: Comparison between Mako Shark S.r.l. and Aerosol Service Italiana S.r.l. on cleanroom’s use.
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Cleanroom’s structure:
Mako Shark S.r.l. Aerosol Service Italiana S.r.l.
The conformation of this cleanroom is designed
according to the needs of production. Indeed, this
cleanroom does not have a material transfer area or
a clothing change area, which are not considered
fundamental for the structure. In addition, entrance
and exit are not regulated by an electronic system,
but personnel pass through an entry cubicle or a
sliding door, used also for the movement of
products and materials. This conformation has
been considered appropriate by the organisation,
who objectives are the control of humidity,
temperature, and macro-contamination. The mayor
part of installed equipment in it is not fixed, and
spaces are distributed according to the type of
production, which can frequently vary.
These cleanrooms reflect the most traditional
structure. All entrances are regulated by electronic
systems and are preceded by material transfer areas
and clothing change areas. Due to the high risk of
contamination, there are specific procedure, which
regulate the entrance of personnel and materials.
The surfaces of cleanrooms are proportionated,
according to the type of production and to the
equipment installed in them. Systems installed are
equipped with high performances filters, which
allow to control the high risk of micro-
contamination of the final product.
Table 4.10: Comparison between Mako Shark S.r.l. and Aerosol Service Italiana S.r.l. on cleanroom’s structure.
Cleanroom’s maintenance:
Mako Shark S.r.l. Aerosol Service Italiana S.r.l.
The company has decided the maintenance of the
cleanroom according to its needs. Indeed, ordinary
maintenance is performed by the responsible
personnel, trained to fulfil the needs of the
organisation and to respects the requirements of
the cleanroom. General maintenance to the HVAC
system is performed by the producer, while the
ordinary controls and monitoring activities are
insourced. Finally, extraordinary maintenance is
performed by the producer organisations.
The organisation manages the maintenance of its
cleanrooms through a tender. This annual contract
is established with a cleanroom producer and
regulates the ordinary and extraordinary
maintenance. The organisation has adopted a
system of books, in which daily the responsible
personnel should register any control, maintenance
activity or problem. In addition, the firm has
decided to establish a system of tickets, through
which manages, registers, and monitors any
extraordinary maintenance. This choice of
management allows to have the total control of the
situations, and a complete documentation, useful
to improve the quality of the organisation.
Table 4.11: Comparison between Mako Shark S.r.l. and Aerosol Service Italiana S.r.l. on cleanroom’s maintenance.
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5. General cleanroom maintenance
Maintenance is defined as: “The combination of all technical and associated
administrative actions, including supervision actions, intended to retain an item in or
restore it to a state in which it can perform its required function. This required function
might be defined as stated condition”23.
The main objective of maintenance is the prevention of breakdown during operations,
ensuring the safety of the work environment. Indeed, maintenance avoids the
deterioration of equipment and structure, which can cause problems to the manufacturing
process.
In order to perform the adequate maintenance actions, it is important to understand and
identify all requirements of the items to maintain. Requirements depend on the
characteristics of the products and are defined according to their life cycle24.
Exist different type of maintenance, and their choice depends on the needs of the item to
be restored. In order to perform and manage in the proper way maintenance actions, it is
important to define a Maintenance Plan25, which allows to constantly control and perform
all maintenance actions.
The correct management of maintenance is fundamental in order to fulfil all needs and
requirements, avoiding possible risks and criticalities. Indeed, associated to maintenance
exist several possible criticalities, which can have different nature. From one side, as
explained in Chapter 3, exists different type of risks, associated to the structure or to the
items to maintain. From the other side, risks and criticalities are related to the maintenance
itself, and to the fact that the wrong or not correctly managed performance of maintenance
can lead to some dysfunctions.
Cleanrooms, as controlled environments, have different requirements and criticalities,
defined by the product and by the manufacturing process. The definition and the choice
of the correct maintenance for a cleanroom has to be chosen in relation to the different
23 British Standard Glossary of terms (3811: 1993). 24 Product life cycle is defined as a process that follows four different stages that a product encounters: introduction stage, growth
stage, maturity stage and decline stage. 25 A structured and documented set of tasks that include the activities, procedures, resources, and the time scale required to carry out
maintenance. (UNI EN 13306:2010, Maintenance terminology)
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requirements of the product, the manufacturing process and the entire firm. For these
reasons, it is important that the cleanroom’s maintenance will be perfectly integrated with
the general one, in order to avoid possible management problem to the entire organisation.
In order to take the correct choice for the type of maintenance and its correct management,
it is important to analyse the general market of cleanroom’s services and the possible
maintenance requirements and criticalities.
5.1 The market of cleanroom services
Cleanroom services means all services related to the field of cleanroom, starting from the
producers, to the company who offer maintenance services.
Due to the particularity of the product analysed, it is important to understand how this
sector is organized and managed, its strong and weak points, and the possible lacks in
terms of services.
It is possible to analyse the organisation of this sector through three main elements:
a) the producers;
b) the maintenance technicians;
c) the certification authority.
a) the producers: exist several firms specialised in the production of components for
cleanrooms. These organisations produce several components for cleanrooms as
walls, doors, false ceiling, glasses, and furniture.
The main services offered by these companies are divided in design, planning and
installation of the components produced. Due to the particularity of the sector, every
project is realized as unique. Indeed, according to the different requirements of the
client, the producer develops a project made to order, customizing every detail for the
specific needs of the product and the process.
The organisation follows every step of the process, without outsourcing any activity.
Indeed, the particularity of the product requires a high level of experience and
technological knowledge, basic conditions to understand and fulfil the needs of the
client.
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b) the maintenance technicians: as demonstrated with the case studies, the
maintenance can be managed in different way, according to the needs and the
objectives of the organisation. As explained in the previous chapters, the maintenance
required could be vary according to the ISO class of the cleanroom, but exist some
basic procedure that are in common with all cleanrooms.
As the market demonstrates, the maintenance of the cleanroom’s structure is
frequently managed by the producers. Indeed, the particularity of the product requires
the experience and the technical capacity of the producer, who is able to perform the
adequate maintenance according to the need of the structure and to its life cycle.
To obtain an adequate manage of all type of maintenance, it is becoming more
common the writing of a contract, tender, between producer and client. The drawing
up of this contract allows to have a constant control and a better management of the
maintenance services. The customer can decide the type of maintenance and its
frequency, or in alternative, can entrust the producer to the choice of the technical
decisions, detailing only a list with all needs of the organisation.
c) the certification authority: certification means all tests and procedures established
by the ISO UNI 14644, in order to define and establish a ISO class for the cleanroom.
Tests and control are usually performed by specific organisation, who are specialised
in test and monitoring of cleanrooms, according to the standards. Indeed, procedures
are performed with the use of a specific equipment, through which technicians can
collect samples of air to estimate the airborne particle concentration, can measure the
airflow of filters, and can analyse the different pressure between external and internal
environments.
Due to the specificity of these procedures and to the frequency to which the norm
requires the certification, this service is offered by autonomous entities, which usually
define a contract for the furniture of this facility.
The market of cleanroom services is well structured and managed. The specificity of the
product requires that the different services offered are divided according to the different
expert technicians or consultants. Activities related to cleanroom are frequently
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outsourced, because the organisation usually does not have the know-how to correctly
perform the different maintenance activities.
The strong point of this market is related to the fact that the producers are not only
manufacturers, but establish a relationship with the client also after the completion of the
project. Their knowledge about cleanrooms allows that maintenance activities will be
performed in the best and correct way, according to standards and requirements of the
client.
Instead, a weak point of this market is related to the specificity and variety of
requirements and needs, which does not allow organisations to be autonomous in their
management. In addition, it is difficult to establish and organize common maintenance
activities, general and adaptable for all cleanroom. Maintenance activities and their
management are specific for every cleanroom, and are defined according to the
requirements and criticalities of the product and the manufacturing process.
5.2 The cleaning
Cleaning is defined as “the act of removing dirt or something undesirable”26. Due to the
necessity to have a sterilize environment and to the high risk of micro and macro
contamination, cleanrooms cleaning is the most important maintenance activity.
Cleanroom cleanliness depends on several factors, among which the efficiency of the air
filtration system, the number of particles generated by workers, machines, products and
equipment and the efficiency of the cleaning activities.
UNI ISO Standard 14644, Annex F, gives some guidelines about the cleaning method,
suggesting a division in steps for the cleaning activity:
- Step 1 - gross cleaning: removal of particles >50 µm;
- Step 2 - precision cleaning: removal of particles 10 – 50 µm;
- Step 3 – accurate cleaning: removal of particles <10 µm.
26 Collins English Dictionary
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Every company decides its cleaning strategy, according to the manufacturing process and
product requirements. Indeed, the specificity of maintenance activities can vary according
to the type of risks identified for the specific production. An organisation operating in the
pharmaceutical of food sector needs more attention on the micro contamination, while
other sectors as the engineering one, requires a higher attention on the macro
contamination.
Regardless, most important common objective is the removal of micro and macro
particles, with the removal and killing of bacteria. This goal can be achieved through
some basic elements to take into account, that has to be implemented by each
organisation, according to their specificity.
These elements are the following:
1. Cleaning strategy;
2. Cleaning equipment;
3. Protective equipment;
4. Personnel training;
5. Cleanliness evaluation.
1. The strategy: many companies decide to apply a stepwise strategy of cleaning, divide
into three main levels:
- Level 1: frequent cleaning of entrances, halls, and offices;
- Level 2: thorough and frequent cleaning of the surrounding environment of the
cleanroom;
- Level 3: very careful and thorough cleaning of clothing change area, material
transfer area and cleanroom itself.
- Level 4: deepened cleaning of equipment and machines used during the
manufacturing process.
This strategy has to be implemented according to the needs of the manufacturing process,
taking into consideration that cleaning have to be performed during the no-production
activity, to avoid the risk of product and environment contamination.
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2. Cleaning equipment: any equipment brought into cleanroom can generate micro or
macro particles, which can contaminate the environment and the product. For this reason,
any equipment used into cleanroom should have a low degree of particle release.
Exists some equipment materials, which cannot be used in the cleanroom, due to the
linting that release, causing contamination. A clear example of one of this material is the
cotton.
Specific equipment, which can be used for cleanroom cleaning, is the following:
- Lint free wipers, mops, dry and wet vacuum cleaners with HEPA filters;
- Lint free ladders, buckets, and wringers;
- Lint free cleanroom garments;
- Lint free gloves, finger cots, pliers, shoe covers, beard covers, face masks;
- Lint free wipes and mops.
There are basic precautions that have to be observed during cleanroom cleaning, some of
them are highlighted by standards. For example, any equipment used for this maintenance
activity is dedicated to cleanroom environment and for this reason cannot be used for the
cleaning of other areas. In addition, any cleaning product or disinfectant can leave
residues on surfaces, which can generate contamination. For this reason, any liquid
applied to remove residues should be residues itself, to minimize the risk of
contamination.
All these cleaning measure can vary according to the product needs, the sector and type
of risks that can occur.
3. Protective equipment: one of the first source of contamination is the worker.
Contamination generated by an individual depends on several factors, among which its
activity, its health condition, and its garment.
For these reason, it is very important to define and choose the adequate gear, to protect
the environment from particles generated by personnel. The right equipment has to be
chosen, according to the needs of the cleanroom, and in specific, to the type of risks which
is subjected. For example, to avoid the macro-contamination risk, can be sufficient to
wear smock and headdress, while to protect the environment by micro-contamination,
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can be necessary to wear more sanitary devices as: gloves, mask, tracksuit, headdress,
and booties.
4. Personnel training: due to the specificity of the environment and the high attention that
the cleanroom cleaning requires, it is necessary to establish some procedures. Procedures
can regard the execution of cleaning activities and the wearing before the entrance in the
cleanroom.
The definition of a procedure is not sufficient to ensure its right execution. For this reason,
it is fundamental that the organisation provides training courses, to instruct personnel
about the correct execution of them. Bad instructed personnel, or the absence of
procedures, can generate several risks. Indeed, the wrong execution of a maintenance
activity or of one of its steps, can generate different kind of contamination, which can
have direct effects on the product and the entire process; for this reason after any training
is recommended a specific test to evaluate personnel skills.
5. Cleanliness evaluation: in order to understand and evaluate the cleanroom cleanliness
and the right execution of cleaning activities, exist some methods:
- UV light;
- Sticky tape;
- Rinse of cleaned areas, followed by analysis of particle content and number of
microorganisms;
- Determination of particle content of cleanroom air.
The application of these methods of analysis can ensure the cleanliness and sterility of
the environment, reducing the risk of contamination.
5.3 Cleanroom functional plans
Cleanroom is composed by different environmental units, each of them has specific
functions, characteristics and environmental conditions. The relationships between
environmental units and their disposition can have a direct impact on maintenance.
Indeed, due to their specific characteristics and requirements, the management and
execution of maintenance in an environmental unit can vary respect to another.
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For these reasons, it is important to understand the functional plan of a cleanroom, taking
into consideration all environmental units that compose it. These information allow to
better organize maintenance activities, taking attention to all possible necessities or risk
factors that can be generated by the environment.
The number, the type and the disposition of environmental units can vary according to
the needs of the manufacturing process. However, exist four basic environments, which
is possible to find in all cleanrooms:
- E.U.1: Cleanroom;
- E.U.2: Clothing change area;
- E.U.3: Material transfer area;
- E.U.4: Storage room.
The following schemas illustrate some examples of functional plan, according to different
environmental unit dispositions:
Figure 5.1: Examples of cleanroom functional plans.
E.U.1
E.U.2 E.U.3
E.U.4 E.U.1
E.U.2 E.U.3
E.U.4
E.U.2
E.U.3
E.U.1
E.U.1
E.U.2
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In order to organize and perform in the correct way maintenance activities, is necessary
and fundamental to take into account the disposition of the different environments that
compose it, and their access. The order of access to the environmental units, or the
disposition of them can vary the execution of maintenance and the risks that can occur in
a cleanroom.
Each maintenance activity can be performed in one or more cleanroom area, and can
generate several risks. This means that will exist an area that could be riskier than other.
In addition, if the highest risky environmental unit corresponds to the first one that is
crossed during the execution of maintenance, risks will be propagate also in the other
areas and will affect the entire cleanroom, worsening. The analysis of these factors can
allow the identification of risky areas and the consequently improvement of maintenance
organisation, in order to avoid or reduce the probability and the impact of risks.
This analysis, considered fundamental in the organisation of maintenance activities, can
lead to different scenarios, that can vary according to the different type of cleanroom.
5.4 Maintenance requirements and criticalities
Maintenance activities and, on consequence, Maintenance Plan is defined according to
the different requirements of the item to unkeep. An incorrect respect of these
requirements or a wrong management and execution of maintenance, can lead to
criticalities formation. In order to ensure the correct execution of maintenance, respecting
cleanrooms needs, it is important to take into consideration both criticalities and
requirements.
In cleanroom sector, requirements are defined by the product, which establish the
guidelines for the design and manage of the cleanroom. Indeed, as specified in the
previous chapters, is the product the focus of the cleanroom. Its workability and the
correct execution of the manufacturing process depend on the environment in which it is
produced.
The characteristics of a cleanroom are defined according to the needs of the product, and
on consequence, the service activities performed should planned according to the
different requirements. This means that it is difficult to define a general Maintenance Plan
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adaptable to all cleanrooms. However, it is possible to define some basic general
requirements, which must be observed and respected for all controlled environments.
Requirements can be split into two different types:
1. requirements of the structure;
2. requirements of the systems.
1. Requirements of the structure: structure indicates the general environment and includes
all the structural parts that compose it, as walls, windows, floor, and doors. As explained
in the first chapter, a cleanroom is constructed with specific materials and components.
These elements are chosen according to the needs of the environment and have specific
characteristics.
General and unavoidable characteristics of the structure are the following:
- Functionality;
- Durability;
- Cleanability;
- Maintainability.
These characteristics, according to the concept of maintenance, become basic and
fundamental requirements, that must be taken into account during the definition of a
maintenance plan.
Functionality: the structure should be functional to ensure the correct performance of the
manufacturing process. It is important that all components of the structure follow
standards, are correctly designed to fulfil the needs of the production, and constantly
controlled, in order to avoid any problem, which can cause a damage to the product or to
the process. A constant and preventive maintenance can fulfil this requirement.
Durability: the structure must be designed to resist in time, avoiding problems to the
manufacturing process. This requirement can be ensured through a preventive
maintenance, which allows to extend the life cycle of all structural parts.
Cleanability: all parts of the structure must be constituted by materials, which are easy to
clean. The sterility of the cleanroom is ensured by a constant and specific cleaning of all
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the structure. This requirement can be fulfilled through an ordinary maintenance, which
should consist in the proper and specific procedure for cleaning. As specified in the
previous chapters, these procedures can vary according to the ISO Class of the cleanroom
and to the type of manufacturing process.
Maintainability: this requirement indicates the ability of an item to be restored or
maintained. This condition is defined during the design phase, when the project is in
developing. The objective of the constructor should be to design a functional and suitable
environment, in which it is possible to perform in an easy way all necessary maintenance
activities. For this reason, a cleanroom should be designed according to the needs of the
product and the manufacturing process, taking into account also maintenance activities.
Indeed, this controlled environment needs a constant control and maintenance, which
have to be performed in the most comfortable way, without causing any problem to the
process.
2. Requirements of the systems: as systems, it means all elements which constitute the
airflow system, the electrical system and other equipment in a cleanroom. A correct and
constant maintenance of these elements ensure a safe and suitable environment for the
personnel, and ensure the continuity of the manufacturing process, avoiding any
breakdown for the production.
Requirements related to the systems are:
- Functionality;
- Maintainability;
- Short recovery time;
- High quality components.
Functionality: systems designed for a cleanroom must be functional to ensure that some
parameters, as for example, humidity and temperature, be always constant, without
causing any damage to the product. For this reason, it is necessary to perform a constant
control and a preventive maintenance, to ensure the correct functionality of all systems.
Maintainability: as for the structure requirements, it is fundamental that all systems are
designed and positioned to ensure an easy maintenance of them in case of necessity. All
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elements must be positioned in a correct space, where all maintenance activities can be
performed without any stop to the manufacturing process and without any difficulty for
the specialised personnel.
Short recovery time: due to the different characteristics of this controlled environment, it
is fundamental that the conditions inside it remain constant. For this reason, it is important
that, in case of any damage or problem to the system, the conditions do not change and
the manufacturing process does not stop. This means that the recovery time should be
near to zero, in order to avoid any production suspension. A minimum time to zero can
ensure the continuity of the system functioning and, on consequence, of the
manufacturing process. This continuity can be ensured through a constant control and a
preventive maintenance on the systems, which can avoid any risk of breakdown.
High quality components: all system presented must ensure that the cleanroom is a safety
environment for the workers and also for the manufacturing process. As illustrated in the
previous chapters, exist different risks associated to this controlled environment, which
can be generated by the outside environment, by the manufacturing process or by the
cleanroom itself. An important requirement is that all systems and equipment installed in
a cleanroom ensure the safety of the environment and the personnel. This safety can be
ensured performing a constant control on the system, joined with a preventive
maintenance, according to the life cycle of all elements.
Criticality means any problematic situation, which can cause damages to the
manufacturing process, to the product or to the personnel. During a maintenance activity,
it is possible to run into a dangerous situation, which can cause a stop of the production.
For this reason, it is fundamental understand and identify all possible criticalities, acting
in the appropriate manner.
After a general identification of possible cleanroom requirements, it is necessary to
consider possible basilar criticalities. Criticalities are correlated to the maintenance
activities and to their requirements. Indeed, they can occur when maintenance is not
performed in the correct way, or when any maintenance requirement is not considered.
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The identification of risks and the recognition of their factors, allow to understand
possible criticalities and take preventive measure, necessary to minimize or avoid any
possible problematic situation.
Due to the specificity of cleanroom environments, and to the different aspects to consider
during maintenance, criticalities can vary among sectors and products. Any maintenance
activity can produce different risks and for a complete recognition of them, it is necessary
to analysis step by step all maintenance actions, identifying all factors that allow their
generation.
However, it is possible to recognize some basilar risks, to whom cleanrooms can be
subjected:
- Contamination;
- Inaccessibility;
- Non-cleanability;
- Failure.
Contamination: the most relevant cleanroom risk is the contamination. This criticality can
be generated by several factors, as micro or macro particles, produced by personnel,
equipment or process. Effects caused by this risk can affect the product contaminating it
or changing the environmental conditions in which it is produced. The importance and
the effects of contamination vary among different sectors, due to the level of sterility
required by the product. For these reason, becomes fundamental minimize or totally avoid
this criticality, adopting different possible solutions, as the appropriate dressing procedure
to avoid personnel contamination.
Inaccessibility: accessibility to structure, equipment and systems allows to correctly
perform maintenance, ensuring maintainability of them. Accessibility to cleanroom is
defined during the design phase, when it is fundamental to take into consideration all
needs of maintenance, to ensure its correct execution. Indeed, any difficulty caused by
inaccessibility to structure and its systems make complicated perform in the correct way
maintenance activities, generating other possible criticalities, as contamination or
failures.
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Non-cleanability: structure, systems and equipment should be chosen and designed to be
easily cleaned, in order to ensure the correct cleaning and sterilization of surfaces. The
non-cleanability of materials can generate the growth of microorganisms, and the
formation of macro and micro contamination, dangerous elements for the product. This
risks can be prevented choosing, during the design phase, rights materials of construction,
adequate to cleanroom requirements. In addition, this risks can be minimized choosing
the right cleaning products and equipment, functional to avoid any contamination
problem, ensuring the right execution of cleanroom cleaning.
Failure: the incorrect execution of maintenance can cause structure and system failures.
A wrong management of maintenance activities can cause this criticality. Indeed, the
incorrect training of personnel, the absence of specific maintenance procedures or the
inexperience of workers can lead to problems during maintenance execution, causing a
degradation of the structure and systems. This criticality should be minimized during the
definition of a Maintenance Plan. In fact, structure, and systems characteristics define the
requirements of them, giving necessary information about their maintenance needs.
These general and basic requirements and criticalities cannot be sufficient to fulfil
cleanroom needs and define the right maintenance plan. These concepts are a base from
which it is possible to start a deepened analysis about maintenance activities, in order to
identify all risks and possible solutions to adopt. As specified in the previous chapters,
this analysis can vary according to the sector and the type of product realized in the
cleanroom.
It is important to highlight that these basilar requirements and criticalities have been
generalized, in order to give a basic knowledge of maintenance. Each concept, focalized
on cleanrooms, should be amplified, and analysed in specific. Indeed, due to the
particularity of the subject, each concept assumes a different connotation respect to its
application on a general and standard structure. The basic concept of maintainability of
structure, usually defined as “the ability of an item under given conditions of use, to be
retained in, or restored to, a state in which it can perform a required function”, assumes a
different meaning if focalized on cleanroom needs. Indeed, to better apply this
requirement, it is necessary to take into consideration several characteristics, which have
a relevance on cleanroom maintenance, as the necessity to not contaminate the
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environment during maintenance or the necessity to respect the correct dressing
procedure during the execution of maintenance activities.
General cleanroom requirements and criticalities
Structural requirements - Functionality
- Durability
- Cleanability
- Maintainability
System requirements - Functionality
- Maintainability
- Short recovery time
- High quality components
Criticalities - Contamination;
- Inaccessibility;
- Non-cleanability;
- Failure
Table 5.1: General cleanroom requirements and criticalities.
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Proposal Part
6. Proposal of a framework for identifying risk factors
connected to maintenance activities
Purpose of this analysis is to propose a framework for the identification of risk factors,
connected to maintenance activities. First objective was to define maintenance tasks,
which define and contain different maintenance activities, grouped by typologies of
maintenance. Then, starting from the definition of tasks, every maintenance activity was
brought up into steps. These steps contain all passage necessary to perform in the correct
way the activity, and indicate the environmental unit in which the step is performed.
Finally, every single step has been analysed, according to one or more possible risks
factors, which can occur during its execution.
Risks factors has been divided into two main categories:
- Personnel, which are connected to workers, who execute maintenance activity.
These factors can be directly generated by the employee, or in alternative, can
regard the workers and have an effect on them;
- Equipment, which are connected to items used during maintenance activities as,
for example, cleaning products.
For each risk factor, has been defined one or more possible solutions to adopt, in order to
delimit or reduce the risk. These possible solutions are divide into the following
typologies:
- Personnel, for solutions to be adopted toward maintenance workers;
- Equipment, for solutions to be adopted toward maintenance gear;
- Project, for solution to be adopted during the design phase of cleanroom.
In specific, the framework can be divided into two main passages. The first one is the
definition of general maintenance information and contains the following data:
- Maintenance tasks;
- Maintenance activities;
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- Explanation of maintenance activities;
- Environmental units where the activity is performed;
- Frequency of the maintenance activity;
- Executor of the maintenance activity.
Every data has a specific code, which allows to summarize all information in a useful and
easily way.
The second part of the framework aims to enter in detail with maintenance information,
and for this reason contains the following information:
- Maintenance activities;
- Maintenance steps;
- Risks;
- Personnel risk factors;
- Equipment risk factors;
- Personnel possible solutions;
- Equipment possible solutions;
- Project possible solutions.
A concrete and real applicability of this framework is given in the following chapters,
where through an analysis about the two case studies, has been applied this tool for the
management of maintenance.
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7. Proposal of a framework for identifying risk factors
connected to maintenance activities: application to Mako
Shark S.r.l.
As explained in the fourth chapter, Mako Shark S.r.l. is a company operating in the
mechanical engineering sector. Part of the manufacturing process of the factory is
developed in a cleanroom, in which the control of temperature, humidity and pressure
allows the workability of composite materials, raw material used in the production.
7.1 Environmental units
The cleanroom is composed by two environmental units27, which have the following
characteristics:
Name Characteristics
E.U.1 Cleanroom - Surface: 137 sqm
- Temperature: +18°C / +27°C
- Relative Humidity: ≤55%
- ISO Class: 8.5
- Function: Execution of pre-cutting and laminating phase.
E.U.2 Clothing change area - Surface: 1.65 sqm
- Temperature: +18°C / +27°C
- Relative Humidity: ≤55%
- ISO Class: 8.5
- Function: Execution of the dressing phase before the entrance in the
cleanroom.
Table 7.1: Mako Shark S.r.l. environmental unit characteristics.
27 Environmental unit: defined space, designed to allows the execution of activities compatible with each other.
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The functional plan of these environmental units is the following:
Figure 7.1: Mako Shark S.r.l. functional plan.
The two environmental units are connected by one doorway, highlighted by the red arrow.
7.2 Tasks and activities
Ordinary maintenance of the cleanroom is executed by internal workers, while
extraordinary one is managed through a contract with an external company, the
constructor of the cleanroom.
Maintenance activities are grouped into the following tasks:
Tasks Activities
Removal of macro-contamination - Empty the machine plans
- Removal of material and equipment
- Empty the garbage containers
Equipment cleaning - Removal of macro-contamination
- Clean machines, equipment, mobile workstations, and chairs
- Clean freezers
- Clean of garbage containers
Environment cleaning - Clean all floors with the specific broom
- Clean all floors with the vacuum cleaner
- Clean doors, windows and recovering grids
- Clean the walls
- Clean ceiling and ceiling lights
- Clean the entrance rubber mat
- Clean filters
Control - Control mobile workstation plans
- Control filters
- Control the insulation components
- Control doors, windows, walls, floors, and ceiling
- Control electronic systems
E.U.1
E.U.2
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- Control the joints of the vacuum system
Substitution - Substitution of insulation components
- Substitution of filters
- Substitution of ceiling lights
- Substitution of mobile workstation plans
Table 7.2: Tasks and activities of Mako Shark S.r.l. maintenance.
7.3 Maintenance steps
Every maintenance activity has been broken down into steps, which describe the
execution of it, indicating the environmental unit in which are carried out.
The following table aims to resume all maintenance activities, detailed according to the
following information:
- Maintenance step;
- Environmental unit in which the activity is carried out;
- Executor of the maintenance activity;
- Frequency of the maintenance.
These data are considered fundamental and necessary for a complete analysis of
maintenance and its risks.
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Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
T.1 Removal of
macro-
contaminatio
n
A.1.1 Empty the
machine plans
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and pick up waste and macro
residuals from the machine plans and from mobile
workstation.
- Bring all the residuals and waste outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Cleaner
A.1.2 Removal of
material and
equipment
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter the E.U.1 and pick up all materials and
equipment used during the production.
- Bring all the materials outside the cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Cleaner
A.1.3 Empty the
garbage
containers
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and pick up all garbage containers.
- Bring the garbage containers outside the cleanroom.
- Sort garbage into different containers.
E.U.1 – E.U.2 Daily Cleaner
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Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
T.2 Equipment
cleaning
A.2.1 Removal of
macro-
contamination
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and take the specific vacuum
cleaner.
- Clean with the vacuum cleaner all the machines and
equipment used during the production.
- Bring the vacuum cleaner outside the cleanroom and
empty it.
- Clean the vacuum cleaner and store it in the E.U.1.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Cleaner
A.2.2 Clean
machines,
equipment,
mobile
workstations,
and chairs
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in E.U.1 with the necessary cleaning equipment
and clean machines, equipment, mobile workstations
and chairs with a cloth moistened with acetone.
- Bring dirty cleaning equipment outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Cleaner
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Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.2.3 Clean freezers - Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in E.U.1 with the necessary cleaning equipment
and clean freezers.
- Bring dirty cleaning equipment outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Quarterly Cleaner
A.2.4 Clean of
garbage
containers
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in E.U.1 and pick all garbage containers.
- Bring garbage containers outside the cleanroom and
wash them with water.
- After the drying of garbage containers, take back
them into cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Quarterly Cleaner
T.3 Environment
cleaning
A.3.1 Clean all
floors with the
specific broom
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and take the specific broom.
- Clean with the specific products and the broom the
floors of the E.U.1 and E.U.2.
E.U.1 – E.U.2 Daily Cleaner
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Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
- Clean the broom and store it in the E.U.1.
- Compile the module of maintenance activity for the
registration of data and information about
cleanroom maintenance.
A.3.2 Clean all
floors with the
vacuum
cleaner
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and take the specific vacuum
cleaner.
- Clean with the vacuum cleaner all floors of the E.U.1
and E.U.2.
- Bring the vacuum cleaner outside the cleanroom and
empty it.
- Clean the vacuum cleaner and store it in the E.U.1.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Cleaner
A.3.3 Clean doors,
windows and
recovering
grids
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Clean doors, windows and recovering grids of the
E.U.1 and E.U.2 with a cloth moistened with acetone.
- Bring dirty cleaning equipment outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Monthly Cleaner
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Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
A.3.4 Clean the
walls
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Clean doors, windows and recovering grids of the
E.U.1 and E.U.2 with a cloth moistened with acetone.
- Bring dirty cleaning equipment outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Annually Cleaner
A.3.5 Clean ceiling
and ceiling
lights
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Clean ceiling and ceiling lights of the E.U.1 and E.U.2
with a cloth moistened with acetone.
- Bring dirty cleaning equipment outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Annually Cleaner
A.3.6 Clean the
entrance
rubber mat
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Bring the entrance rubber mat outside the cleanroom
and wash it with water.
- After the drying of the entrance rubber mat, take back
it into E.U.2.
E.U.1 – E.U.2 Weekly Cleaner
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Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
A.3.7 Clean filters - Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Clean filters of the E.U.1 with the specific cleaning
products.
- Bring dirty cleaning equipment outside the
cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Monthly Cleaner
T.4 Control A.4.1 Control mobile
workstation
plans
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Control the integrity of the mobile workstation plans
of the E.U.1.
- In case of damages, change the plan of the mobile
workstation.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Technician
Chapter 7
98
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.4.2 Control filters - Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Control the correct functioning of filters of the E.U.1.
- In case of damages, follow the procedure of
extraordinary maintenance, calling the external
maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Weekly Technician
A.4.3 Control the
insulation
components
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Control the insulation components of the E.U.1 and
E.U.2.
- In case of damages, follow the procedure of
extraordinary maintenance, calling the external
maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Technician
Chapter 7
99
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.4.4 Control doors,
windows,
walls, floors,
and ceiling
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Control the doors, windows, walls, floors and ceiling
of the E.U.1 and E.U.2.
- In case of damages, follow the procedure of
extraordinary maintenance, calling the external
maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Technician
A.4.5 Control
electronic
systems
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Control the correct functioning of the electronic
systems for the registration of environmental
parameters of the E.U.1 and E.U.2.
- In case of damages, follow the procedure of
extraordinary maintenance, calling the external
maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Daily Technician
Chapter 7
100
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.4.6 Control the
joints of the
vacuum
system
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Control the correct functioning of the joint of the
vacuum system of the E.U.1.
- In case of damages, follow the procedure of
extraordinary maintenance, calling the external
maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Weekly Technician
T.5 Substitution A.5.1 Substitution of
insulation
components
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and disassemble the old insulation
components, putting them into a package.
- Clean the area, with a cloth moistened with acetone.
- Assemble the new insulation components.
- Bring old components outside cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Annually Technician
Chapter 7
101
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.5.2 Substitution of
filters
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and disassemble the old filters,
putting them into a package.
- Clean the area, with a cloth moistened with acetone.
- Assemble the new filters.
- Bring old components outside cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Annually Technician
A.5.3 Substitution of
ceiling lights
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and disassemble the old ceiling
lights, putting them into a package.
- Clean the area, with a cloth moistened with acetone.
- Assemble the ceiling lights.
- Bring old components outside cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 Annually Technician
A.5.4 Substitution of
mobile
workstation
plans
- Enter in E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: smock and
headdress.
- Enter in the E.U.1 and disassemble the old plans of
the mobile workstation, putting them into a package.
- Clean the area, with a cloth moistened with acetone.
E.U.1 – E.U.2 Biyearly Technician
Chapter 7
102
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
- Assemble the mobile workstation plans.
- Bring old components outside cleanroom.
- Compile the module of maintenance activity for the
registration of data and information about
cleanroom maintenance.
Table 7.3: Mako Shark S.r.l. maintenance activities.
Chapter 7
103
7.4 Maintenance risk factors: the macro-contamination hazard
The last passage of the analysis aims to examine every single step of each maintenance
activity, to highlights and understand possible risks factors, and indicate one or more
possible solutions.
This analysis allows to obtain different information about maintenance, among which a
list of possible risks, which can occur during the execution of maintenance.
The possible risks are the following:
Risk Description
Macro-contamination Contamination generated by macro particles, which are defined as particles
visible to the naked eye.
Environmental contamination Contamination, which affects the environmental parameters of the cleanroom
as pressure, humidity, and temperature.
Mismanagement Bad management of maintenance activity, which can occur when the company
does not provide maintenance documentation, the personnel does not compile
the documentation or when extraordinary maintenance procedures are not
followed.
Organisational inefficiency Inadequate or absent managerial efficiency, caused by the not-transmission of
maintenance information or by an inadequate management of maintenance
activities.
No feedback information Absence of transmission or exchange of maintenance information,
fundamental for the development and improvement of maintenance
organisation.
Standard violation Non-compliance with standards about the sort of normal and special waste and
production residuals.
Spatial inefficiency Inefficiency caused by lack of an adequate space where perform maintenance,
or absence of necessary space where store the necessary equipment.
Item failure Termination of the ability of an item to perform a required function, generated
by inexperience of maintenance worker, non-fulfilment of maintenance
activities, or non-respect of maintenance procedures.
Item obsolescence Inability of an item to be maintained due to the unavailability on the market
of the necessary resources at acceptable technical and/or economic conditions,
caused by inexperience of maintenance worker, non-fulfilment of
maintenance activities, or non-respect of maintenance procedures.
Item degradation Detrimental change in physical condition, with time, use or external cause of
an item, caused by inexperience of maintenance worker, non-fulfilment of
maintenance activities, or non-respect of maintenance procedures.
System malfunctioning Malfunctioning of systems caused by inexperience of maintenance worker,
non-fulfilment of maintenance activities, or non-respect of maintenance
procedures.
Structural malfunctioning Malfunctioning of the structure generated by inexperience of maintenance
worker, non-fulfilment of maintenance activities, or non-respect of
maintenance procedures.
Equipment malfunctioning Malfunctioning of the equipment caused by inexperience of maintenance
worker, non-fulfilment of maintenance activities, or non-respect of
maintenance procedures.
Table 7.4: Mako Shark S.r.l. maintenance risks.
Chapter 7
104
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.1.1 Empty the
machine plans
S.1.1.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.1.1.2 Enter in the
E.U.1 and pick
up waste and
macro
residuals from
the machine
plans and from
mobile
workstation.
Macro-
contamination
Worker does not
collect all waste
and macro
residuals, leaving
contamination.
Request a visual
control after the
maintenance
activity.
Provide a form to
fill, to be used as
control check list
after the
maintenance
activity.
S.1.1.3 Bring all the
residuals and
waste outside
the cleanroom.
Chapter 7
105
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.1.1.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.1.2 Removal of
material and
equipment
S.1.2.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
106
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.1.2.2 Enter the
E.U.1 and pick
up all
materials and
equipment
used during
the production.
Macro-
contamination
Worker does not
collect all
materials and
equipment used
during production,
leaving
contamination.
Request a visual
control after the
maintenance
activity.
Provide a form to
fill, to be used as
control check list
after the
maintenance
activity.
S.1.2.3 Bring all the
materials
outside the
cleanroom.
S.1.2.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Chapter 7
107
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.1.3 Empty the
garbage
containers
S.1.3.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.1.3.2 Enter in the
E.U.1 and pick
up all garbage
containers.
Macro-
contamination
Worker does not
collect all garbage
containers,
leaving
contamination.
Request a visual
control after the
maintenance
activity.
Provide a form to
fill, to be used as
control check list
after the
maintenance
activity.
S.1.3.3 Bring the
garbage
containers
outside the
cleanroom.
Macro-
contamination
Environmental
contamination
Worker leave the
dirty garbage
containers inside
cleanroom,
contaminating the
environment.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Chapter 7
108
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does
not plan any
training course for
personnel
education.
S.1.3.4 Sort garbage
into different
containers.
Standard
violation
Spatial
inefficiency
Worker does not
know the
standards about
the sort of garbage
into different
containers.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide
different garbage
containers
according to
standards.
Instruct personnel
about the sort of
garbage procedure,
organizing a
training course.
Purchase the
correct garbage
containers,
according to
standards.
Design the specific
area outside the
cleanroom, where
position the garbage
containers.
S.1.3.5 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Chapter 7
109
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.2.1 Removal of
macro-
contamination
S.2.1.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.2.1.2 Enter in the
E.U.1 and take
the specific
vacuum
cleaner.
Macro-
contamination
Worker does not
know the correct
procedure and
bring a vacuum
cleaner from the
outside,
generating micro
and macro
contamination.
Organisation does
not supply the
cleanroom with a
dedicated vacuum
cleaner.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Purchase a
vacuum cleaner
used only in the
cleanroom and
execute its
maintenance
monthly.
S.2.1.3 Clean with the
vacuum
cleaner all the
machines and
equipment
used during
the production.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Chapter 7
110
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does
not plan any
training course for
personnel
education.
S.2.1.4 Bring the
vacuum
cleaner outside
the cleanroom
and empty it.
Macro-
contamination
Environmental
contamination
Worker leave the
dirty vacuum
cleaner inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.2.1.5 Clean the
vacuum
cleaner and
store it in the
E.U.1.
Macro-
contamination
Spatial
inefficiency
Worker does not
know the correct
procedure and
does not clean and
store the vacuum
cleaner.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not design the
correct space,
where store the
vacuum cleaner in
the E.U.1.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Design a dedicated
space for the vacuum
cleaner.
Chapter 7
111
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.2.1.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.2.2 Clean
machines,
equipment,
mobile
workstation,
and chairs
S.2.2.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
112
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.2.2.2 Enter in E.U.1
with the
necessary
cleaning
equipment and
clean
machines,
equipment,
mobile
workstations
and chairs with
a cloth
moistened
with acetone.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Design a dedicated
warehouse for the
cleaning products and
equipment for the
cleanroom, positioned
outside it.
S.2.2.3 Bring dirty
cleaning
equipment
outside the
cleanroom.
Macro-
contamination
Environmental
contamination
Worker leaves
dirty cleaning
equipment inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.2.2.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
Chapter 7
113
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
cleanroom
maintenance.
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
collection of data
and information.
of maintenance
activities.
maintenance,
improving it.
A.2.3 Clean freezers S.2.3.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.2.3.2 Enter in E.U.1
with the
necessary
cleaning
equipment and
clean freezers.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
Design a dedicated
warehouse for the
cleaning products and
equipment for the
cleanroom, positioned
outside it.
Chapter 7
114
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
personnel
education.
outside the
cleanroom.
S.2.3.3 Bring dirty
cleaning
equipment
outside the
cleanroom.
Macro-
contamination
Environmental
contamination
Worker leaves
dirty cleaning
equipment inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.2.3.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Chapter 7
115
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.2.4 Clean of
garbage
containers
S.2.4.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.2.4.2 Enter in E.U.1
and pick all
garbage
containers.
Macro-
contamination
Worker does not
collect all garbage
containers,
leaving
contamination.
Request a visual
control after the
maintenance
activity.
Provide a form to
fill, to be used as
control check list
after the
maintenance
activity.
S.2.4.3 Bring garbage
containers
outside the
cleanroom and
wash them
with water
Macro-
contamination
Environmental
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Chapter 7
116
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does
not plan any
training course for
personnel
education.
S.2.4.4 After the
drying of
garbage
containers,
take back them
into
cleanroom.
S.2.4.5 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.3.1 Clean all
floors with the
specific
broom
S.3.1.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
117
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
smock and
headdress.
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
at the entrance of the
E.U.2, with a
detailed explanation
of the dressing
procedure.
S.3.1.2 Enter in the
E.U.1 and take
the specific
broom.
Macro-
contamination
Worker does not
know the correct
procedure and
bring a broom
from the outside,
generating macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not supply the
cleanroom with a
dedicated broom.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Purchase a
broom used only
in the cleanroom
and organize its
substitution
weekly.
S.3.1.3 Clean with the
specific
products and
the broom the
floors of the
E.U.1 and
E.U.2.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
Organisation does
not supply worker
with necessary
products for the
cleanroom
cleaning.
Materials used for
the floor
construction
allows the
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of cleaning
products,
stocking up a
minimum
quantity of
them.
Design and organize
the necessary space in
the E.U.4 for the
storage of cleaning
products.
Choose materials of
construction with the
following
characteristics:
Chapter 7
118
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
personnel
education.
generation of
particles, are not
easily cleanable,
water resistant,
durable,
chemically inert,
antistatic and does
not have an
airtight structure.
This does not
allow a correct
cleaning and
generate the risk
of macro
contamination.
-capacity to not
generate particles;
- capacity to be easily
cleaned;
- capacity to resist to
water, detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have an
airtight structure.
S.3.1.4 Clean the
broom and
store it in the
E.U.1.
Macro-
contamination
Spatial
inefficiency
Worker takes the
broom inside the
cleanroom
without clean it
after the use. This
can generate the
risk of macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not design the
correct space,
where store the
broom in the
E.U.1.
Instruct personnel
about the correct
procedure about the
cleaning of the
broom.
Design a dedicated
space for the broom.
S.3.1.5 Compile the
module of
maintenance
activity for the
registration of
Mismanagement
Organisational
inefficiency
Worker does not
know the correct
procedure for
maintenance
activity
Organisation does
not provide the
necessary
documentation
and modules for
Instruct personnel
about the
maintenance
procedure,
providing the
Create an information
system for the
management of
maintenance
activities. This allow
Chapter 7
119
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
data and
information
about
cleanroom
maintenance.
No feedback
information
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
the registration of
maintenance
activities and the
collection of data
and information.
necessary modules
for the registration
of maintenance
activities.
to organize, collect
and manage all
information about
maintenance,
improving it.
A.3.2 Clean all
floors with the
vacuum
cleaner
S.3.2.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.3.2.2 Enter in the
E.U.1 and take
the specific
vacuum
cleaner.
Macro-
contamination
Worker does not
know the correct
procedure and
bring a vacuum
cleaner from the
outside,
generating macro
contamination.
Organisation does
not supply the
cleanroom with a
dedicated vacuum
cleaner.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Purchase a
vacuum cleaner
used only in the
cleanroom and
execute its
maintenance
monthly.
Chapter 7
120
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.2.3 Clean with the
vacuum
cleaner all
floors of the
E.U.1 and
E.U.2.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course
S.3.2.4 Bring the
vacuum
cleaner outside
the cleanroom
and empty it.
Macro-
contamination
Environmental
contamination
Worker leave the
dirty vacuum
cleaner inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.3.2.5 Clean the
vacuum
cleaner and
store it in the
E.U.1.
Macro-
contamination
Spatial
inefficiency
Worker does not
know the correct
procedure and
take the vacuum
cleaner inside the
cleanroom
without clean it
after the use. This
can generate the
Organisation does
not design the
correct space,
where store the
vacuum cleaner in
the E.U.1.
Instruct personnel
about the correct
procedure about the
cleaning of the
vacuum cleaner.
Design a dedicated
space for the vacuum
cleaner.
Chapter 7
121
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
risk of macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
S.3.2.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.3.3 Clean doors,
windows and
recovering
grids
S.3.3.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
122
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
training course for
personnel
education.
S.3.3.2 Clean doors,
windows and
recovering
grids of the
E.U.1 and
E.U.2 with a
cloth
moistened
with acetone.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom
cleaning.
Materials used for
the construction
allows the
generation of
particles, are not
easily cleanable,
water resistant,
durable,
chemically inert,
antistatic and does
not have an
airtight structure.
This does not
allow a correct
cleaning and
generate the risk
of micro and
macro
contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them.
Design and organize
the necessary space in
the E.U.4 for the
storage of cleaning
products.
Choose materials of
construction with the
following
characteristics:
- capacity to not
generate particles;
- capacity to be easily
cleaned;
- capacity to resist to
water, detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have an
airtight structure.
Chapter 7
123
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.3.3 Bring dirty
cleaning
equipment
outside the
cleanroom.
Macro-
contamination
Environmental
contamination
Worker leaves
dirty cleaning
equipment inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.3.3.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.3.4 Clean the
walls
S.3.4.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
124
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
smock and
headdress.
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
the E.U.2, with a
detailed explanation
of the dressing
procedure.
S.3.4.2 Clean doors,
windows and
recovering
grids of the
E.U.1 and
E.U.2 with a
cloth
moistened
with acetone.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom
cleaning.
Materials used for
the walls
construction
allows the
generation of
particles, are not
easily cleanable,
water resistant,
durable,
chemically inert,
antistatic and does
not have an
airtight structure.
This does not
allow a correct
cleaning and
generate the risk
of micro and
macro
contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them.
Design and organize
the necessary space in
the E.U.4 for the
storage of cleaning
products.
Choose materials of
construction with the
following
characteristics:
- capacity to not
generate particles;
- capacity to be easily
cleaned;
- capacity to resist to
water, detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have an
airtight structure.
Chapter 7
125
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.4.3 Bring dirty
cleaning
equipment
outside the
cleanroom.
Macro-
contamination
Environmental
contamination
Worker leaves
dirty cleaning
equipment inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.3.4.7 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.3.5 Clean ceiling
and ceiling
lights
S.3.5.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
126
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
smock and
headdress.
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
the E.U.2, with a
detailed explanation
of the dressing
procedure.
S.3.5.2 Clean ceiling
and ceiling
lights of the
E.U.1 and
E.U.2 with a
cloth
moistened
with acetone.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom
cleaning.
Materials used for
the ceiling
construction
allows the
generation of
particles, are not
easily cleanable,
water resistant,
durable,
chemically inert,
antistatic and does
not have an
airtight structure.
This does not
allow a correct
cleaning and
generate the risk
of micro and
macro
contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them.
Design and organize
the necessary space in
the E.U.4 for the
storage of cleaning
products.
Choose materials of
construction with the
following
characteristics:
- capacity to not
generate particles;
- capacity to be easily
cleaned;
- capacity to resist to
water, detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have an
airtight structure.
Chapter 7
127
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.5.3 Bring dirty
cleaning
equipment
outside the
cleanroom.
Macro-
contamination
Environmental
contamination
Worker leaves
dirty cleaning
equipment inside
cleanroom,
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.3.5.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.3.6 Clean the
entrance
rubber mat
S.3.6.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
128
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
smock and
headdress.
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
the E.U.2, with a
detailed
explanation of the
dressing procedure.
S.3.6.2 Bring the
entrance
rubber mat
outside the
cleanroom and
wash it with
water.
S.3.6.3 After the
drying of the
entrance
rubber mat,
take back it
into E.U.2.
S.3.6.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Chapter 7
129
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
personnel
education.
A.3.7 Clean filters S.3.7.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.3.7.2 Clean filters of
the E.U.1 with
the specific
cleaning
products.
Macro-
contamination
Worker does not
clean in the
correct and
deepened way,
generating the risk
of contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom
cleaning.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them.
S.3.7.3 Bring dirty
cleaning
equipment
Macro-
contamination
Worker leaves
dirty cleaning
equipment inside
cleanroom,
Instruct personnel
about the correct
procedure,
Chapter 7
130
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
outside the
cleanroom.
Environmental
contamination
contaminating the
environment.
Organisation does
not plan any
training course for
personnel
education.
organizing a
training course.
S.3.7.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.4.1 Control
mobile
workstation
plans
S.4.1.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
131
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
training course for
personnel
education.
S.4.1.2 Control the
integrity of the
mobile
workstation
plans of the
E.U.1.
Macro-
contamination
Item failure
Item
obsolescence
Item
degradation
Worker does not
control in the most
accurate way the
integrity of mobile
workstation plans.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.4.1.3 In case of
damages,
change the
plan of the
mobile
workstation.
Mismanagement
Item failure
Macro-
contamination
Worker does not
evaluate in the
correct way the
state of the mobile
workstation plans
and does not
change them.
Worker is not able
to change the
mobile
workstation plans.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Chapter 7
132
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.1.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.4.2 Control filters S.4.2.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
133
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.2.2 Control the
correct
functioning of
filters of the
E.U.1.
Macro-
contamination
Item failure
Item
obsolescence
Item
degradation
Worker does not
know the
functioning of
filters and he is not
able to control
their operation.
Organisation does
not plan any
training course for
personnel
education.
Worker is not able
to control filters,
due to the
inaccessibility to
them. Indeed,
filters can be
positioned in
unattainable
points or can be
barrier which
impede their
accessibility.
Organisation does
not choose high
quality
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Instruct personnel
about the
functioning of
filters, organizing a
training course.
Position filters where
it is possible to
execute their
maintenance easily,
without barriers,
which can impede
their accessibility.
Choose high quality
components, which
are available, reliable
and durable.
S.4.2.3 In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and
try to repair
possible damages,
causing a failure
in the system.
Instruct personnel
about the procedure
of extraordinary
maintenance,
organising a training
course and provide
the necessary
documentation for
Establish a technical
agreement with an
external organization
for the provision of
extraordinary
maintenance works.
Chapter 7
134
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
maintenance
worker.
Organisation does
not plan any
training course for
personnel
education.
the opening of
procedure.
S.4.2.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.4.3 Control the
insulation
components
S.4.3.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
135
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.3.2 Control the
insulation
components of
the E.U.1 and
E.U.2.
Macro-
contamination
Item failure
Item
obsolescence
Item
degradation
Organisation does
not choose high
quality
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Choose high quality
components, which
are available, reliable
and durable.
S.4.3.3 In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and
try to repair
possible damages,
causing a failure
in the system.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the procedure
of extraordinary
maintenance,
organising a training
course and provide
the necessary
documentation for
the opening of
procedure.
Establish a technical
agreement with an
external organization
for the provision of
extraordinary
maintenance works.
Chapter 7
136
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.3.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.4.4 Control doors,
windows,
walls, floors,
and ceiling
S.4.4.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
137
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.4.2 Control the
doors,
windows,
walls, floors
and ceiling of
the E.U.1 and
E.U.2.
Macro-
contamination
Item failure
Item
obsolescence
Item
degradation
Organisation does
not choose high
quality
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Choose high quality
components, which
are available, reliable
and durable.
S.4.4.3 In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and
try to repair
possible damages,
causing a failure
in the system.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the procedure
of extraordinary
maintenance,
organising a training
course and provide
the necessary
documentation for
the opening of
procedure.
Establish a technical
agreement with an
external organization
for the provision of
extraordinary
maintenance works.
Chapter 7
138
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.4.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.4.5 Control
electronic
systems
S.4.5.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of the
E.U.2, with a
detailed explanation
of the dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
139
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.5.2 Control the
correct
functioning of
the electronic
systems for the
registration of
environmental
parameters of
the E.U.1 and
E.U.2.
Macro-
contamination
Item failure
Item
obsolescence
Item
degradation
Worker does not
know the
functioning of
electronic systems
and he is not able
to control their
operation.
Organisation does
not plan any
training course for
personnel
education.
Worker is not able
to control
electronic
systems, due to the
inaccessibility to
them. Indeed, they
can be positioned
in unattainable
points or can be
barrier which
impede their
accessibility.
Organisation does
not choose high
quality
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Instruct personnel
about the
functioning of
electronic systems,
organizing a
training course.
Position electronic
systems outside
cleanrooms doors,
where it is possible to
read the
environmental
parameters and
execute their
maintenance easily.
Choose high quality
components, which
are available, reliable
and durable.
S.4.5.3 In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and
try to repair
possible damages,
Instruct personnel
about the procedure
of extraordinary
maintenance,
organising a training
course and provide
the necessary
documentation for
Chapter 7
140
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
maintenance
worker.
causing a failure
in the system.
Organisation does
not plan any
training course for
personnel
education.
the opening of
procedure.
S.4.5.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.4.6 Control the
joints of the
vacuum
system
S.4.6.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
141
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
training course for
personnel
education.
S.4.6.2 Control the
correct
functioning of
the joint of the
vacuum
system of the
E.U.1.
Macro-
contamination
Item failure
Item
obsolescence
Item
degradation
Worker does not
know the
functioning of
vacuum systems
and he is not able
to control its
operation.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not choose high
quality
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Instruct personnel
about the
functioning of
electronic systems,
organizing a
training course.
Choose high quality
components, which
are available, reliable
and durable.
S.4.6.3 In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and
try to repair
possible damages,
causing a failure
in the system.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the procedure
of extraordinary
maintenance,
organising a training
course and provide
the necessary
documentation for
the opening of
procedure.
Chapter 7
142
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.6.4 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.5.1 Substitution
of insulation
components
S.5.1.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
143
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.1.2 Enter in the
E.U.1 and
disassemble
the old
insulation
components,
putting them
into a package.
Macro-
contamination
Worker does not
know the correct
procedure and
does not put the
contaminated and
old insulation
components into a
package, after
having
disassembled it.
This can generate
macro
contamination.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging materials
outside the
cleanroom, where
store the necessary
materials.
S.5.1.3 Clean the area,
with a cloth
moistened
with acetone.
Macro-
contamination
Worker does not
know the correct
procedure and
does not clean the
area of
intervention. This
can generate the
risk of macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure of
cleaning, organizing
a training course.
Chapter 7
144
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.1.4 Assemble the
new insulation
components.
Structural
malfunctioning
Organisation does
not choose high
quality insulation
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Choose high quality
components, which
are available, reliable
and durable.
S.5.1.5 Bring old
components
outside
cleanroom.
S.5.1.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Chapter 7
145
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.5.2 Substitution
of filters
S.5.2.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.5.2.2 Enter in the
E.U.1 and
disassemble
the old filters,
putting them
into a package.
Macro-
contamination
Worker does not
know the correct
procedure and
does not put the
contaminated and
old insulation
components into a
package, after
having
disassembled it.
This can generate
macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging materials
outside the
cleanroom, where
store the necessary
materials.
Chapter 7
146
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.2.3 Clean the area,
with a cloth
moistened
with acetone.
Macro-
contamination
Worker does not
know the correct
procedure and
does not clean the
area of
intervention. This
can generate the
risk of macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure of
cleaning, organizing
a training course.
S.5.2.4 Assemble the
new filters.
System
malfunctioning
Organisation does
not choose high
quality filters. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Choose high quality
components, which
are available, reliable
and durable.
Chapter 7
147
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.2.5 Bring old
components
outside
cleanroom.
S.5.2.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
A.5.3 Substitution
of ceiling
lights
S.5.3.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
Chapter 7
148
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.3.2 Enter in the
E.U.1 and
disassemble
the old ceiling
lights, putting
them into a
package.
Macro-
contamination
Worker does not
know the correct
procedure and
does not put the
contaminated and
old insulation
components into a
package, after
having
disassembled it.
This can generate
macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging materials
outside the
cleanroom, where
store the necessary
materials.
S.5.3.3 Clean the area,
with a cloth
moistened
with acetone.
Macro-
contamination
Worker does not
know the correct
procedure and
does not clean the
area of
intervention. This
can generate the
risk of macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure of
cleaning, organizing
a training course.
Chapter 7
149
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.3.4 Assemble the
ceiling lights.
Structural
malfunctioning
Organisation does
not choose high
quality lights. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Choose high quality
components, which
are available, reliable
and durable.
S.5.3.5 Bring old
components
outside
cleanroom.
S.5.3.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Chapter 7
150
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.5.4 Substitution
of mobile
workstation
plans
S.5.4.1 Enter in E.U.2
and perform
the dressing
procedure,
wearing the
following
sanitary
devices:
smock and
headdress.
.
Macro-
contamination
Environmental
contamination
Worker can enter
in the cleanroom
without wearing
one or more
sanitary devices,
generating macro
contamination for
the environment
and the entire
production.
Organisation does
not plan any
training course for
personnel
education.
The organisation
does not provide
an adequate
supply of sanitary
devices, as smock
and headdresses.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information plaque
at the entrance of
the E.U.2, with a
detailed
explanation of the
dressing procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for sanitary
devices at the
entrance of the E.U.2,
positioned next the
information plaque
about dressing
procedure.
S.5.4.2 Enter in the
E.U.1 and
disassemble
the old plans
of the mobile
workstation,
putting them
into a package.
Macro-
contamination
Worker does not
know the correct
procedure and
does not put the
contaminated and
old insulation
components into a
package, after
having
disassembled it.
This can generate
macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging materials
outside the
cleanroom, where
store the necessary
materials.
Chapter 7
151
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.4.3 Clean the area,
with a cloth
moistened
with acetone.
Macro-
contamination
Worker does not
know the correct
procedure and
does not clean the
area of
intervention. This
can generate the
risk of macro
contamination.
Organisation does
not plan any
training course for
personnel
education.
Instruct personnel
about the correct
procedure of
cleaning, organizing
a training course.
S.5.4.4 Assemble the
mobile
workstation
plans.
Equipment
malfunctioning
Organisation does
not choose high
quality
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This
can generate the
risk of failure of
items and the
necessity of a
frequent
maintenance.
Choose high quality
components, which
are available, reliable
and durable.
Chapter 7
152
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.4.5 Bring old
components
outside
cleanroom.
S.5.4.6 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance
activity
registration and
does not compile
the module.
Organisation does
not plan any
training course for
personnel
education.
Organisation does
not provide the
necessary
documentation
and modules for
the registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary modules
for the registration
of maintenance
activities.
Create an information
system for the
management of
maintenance
activities. This allow
to organize, collect
and manage all
information about
maintenance,
improving it.
Table 7.5: Mako Shark S.r.l. framework application.
Chapter 8
153
8. Proposal of a framework for identifying risks factors
connected to maintenance activities: application to Aerosol
Service Italiana S.r.l.
As explained in the fourth chapter, Aerosol Service Italiana S.r.l. is a company operating
in the pharmaceutical sector. Part of the manufacturing process of the factory is developed
in a cleanroom, in which the control of temperature, humidity and pressure allows to
obtain the adequate sterilized environment for the production of pharmaceutical and
cosmetic products.
8.1 Environmental units
The cleanroom is composed by four environmental units, with the following
characteristics:
Name Characteristics
E.U.1 Cleanroom
- Surface: 83.7 sqm
- Temperature: +20°C / +24°C
- Relative Humidity: 50%
- ISO Class: 7
- GMP Grade: C
- Function: Execution of the replenishment and packaging phase of the
manufacturing process.
E.U.2 Clothing change area
- Surface: 10 sqm
- Temperature: +20°C / +24°C
- Relative Humidity: 50%
- ISO Class: 7
- GMP Grade: C
- Function: Execution of the dressing phase before the entrance in the
cleanroom.
E.U.3 Material transfer area
- Surface: 10 sqm
- Temperature: +20°C / +24°C
- Relative Humidity: 50%
- ISO Class: 7
- GMP Grade: C
- Function: Passage and sterilization of the material before the entrance
in the cleanroom.
Chapter 8
154
Table 8.1: Aerosol Service Italiana S.r.l. environmental unit characteristics.
The functional plan of this cleanroom is the following:
Figure 8.1: Aerosol Service Italiana S.r.l. functional plan.
Red arrows highlight connections and relationships among the different environmental
units.
8.2 Tasks and activities
The organisation has adopted different strategies for the management of maintenance.
Ordinary cleaning is performed by internal workers, while all other ordinary maintenance
activities and extraordinary ones are outsourced.
Company maintenance activities are the following:
Tasks Activities
Removal of macro-contamination - Empty the machine plans
- Removal of material and equipment
- Empty the garbage containers
Equipment cleaning - Removal of macro-contamination
- Clean the internal parts of machines
- Clean all parts of machines
- Clean cabinets and benches
Environment cleaning - Clean all floors with the specific broom
- Clean all floors with the vacuum cleaner
E.U.4 Storage room
- Surface: 6 sqm
- Temperature: +20°C / +24°C
- Relative Humidity: 50%
- ISO Class: 7
- GMP Grade: C
- Function: Storage of materials and equipment used in the cleanroom.
E.U.1
E.U.2 E.U.3
E.U.4
Chapter 8
155
- Clean doors, windows and recovering grids
- Clean the walls
- Clean ceiling and ceiling lights
- Clean filters
Sanitization - Sanitize doors, windows, walls and recovering grids
- Sanitize floors
- Sanitize equipment and machines
Control - Control the correct functioning of doors
- Control filters
- Control the insulation components
- Control doors, windows, walls, floors, and ceiling
- Control magnehelic systems
Substitution - Substitution of insulation components
- Substitution of filters
- Substitution of ceiling lights
Table 8.2: Tasks and activities of Aerosol Service Italiana S.r.l. maintenance.
8.3 Maintenance steps
Every maintenance activity has been broken down into steps, which describe the
execution of it, indicating the environmental unit in which are carried out.
The following table aims to resume all maintenance activities, detailed according to the
following information:
- Maintenance step;
- Environmental unit in which the activity is carried out;
- Executor of the maintenance activity;
- Frequency of the maintenance.
These data are considered fundamental and necessary for a complete analysis of
maintenance and its risks.
Chapter 8
156
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
T.1
Removal of
macro-
contamination
A.1.1 Empty the
machine plans
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.1 and pick up waste and macro residuals
from the machine plans.
- Sort waste and residuals in the opposite containers.
- Bring all the residuals and waste outside the cleanroom,
passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
Daily / After
final
production
Cleaner
A.1.2
Removal of
material and
equipment
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter the E.U.1 and pick up all materials and equipment
used during the production.
- Clean with a cloth all equipment used during the
production and stores it into the E.U.4.
- Bring all the materials outside the cleanroom, passing
through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4
After final
production Cleaner
Chapter 8
157
Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
A.1.4
Empty the
garbage
containers
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.1 and pick up all garbage containers,
sealing them.
- Bring the garbage containers outside the cleanroom,
passing through the E.U.3.
- Sort garbage into different containers, according to the
pharmaceutical standards.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
Daily / After
final
production
Cleaner
T.2 Equipment
cleaning A.2.1
Removal of
macro-
contamination
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.4 and take the specific vacuum cleaner.
- Enter in the E.U.1 and clean with the vacuum cleaner all
the machines and equipment used during the production.
- Bring the vacuum cleaner outside the cleanroom, passing
through the E.U.3, and empty it.
- Sterilize the vacuum cleaner in the E.U.3, and store it in
the E.U.4.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4
Daily / After
final
production
Cleaner
A.2.2
Clean the
internal parts of
machines
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.1 and isolate the electric parts of the
machines with a tarp.
- Blow with compressed air all internal parts of machines.
-
E.U.1 – E.U.2 – E.U.3 After final
production Cleaner
Chapter 8
158
Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
A.2.3 Clean all parts
of machines
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary products and
equipment.
- Enter in the E.U.1 and isolate the electric parts of the
machines with a tarp.
- Clean with a cloth moistened with alcohol all parts of
machines.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
Daily /
After final
production /
Before new
production /
Monthly /
Quarterly
Cleaner
A.2.4 Clean cabinets
and benches
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary products and
equipment.
- Enter in the E.U.2 and clean internally and externally all
cabinets. Then, clean all benches.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
-
E.U.2 – E.U.3
Daily /
After final
production /
Before new
production /
Monthly /
Quarterly
Cleaner
Chapter 8
159
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
T.3 Environment
cleaning A.3.1
Clean all floors
with the
specific broom
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.4 and take the specific broom.
- Clean with the specific products and the broom the floors
of the E.U.1, E.U.2, E.U.3, and E.U.4.
- Sterilize the broom in the E.U.3, and store it in the E.U.4.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4
Daily /
After final
production /
Monthly /
Quarterly
Cleaner
A.3.2
Clean all floors
with the
vacuum cleaner
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.4 and take the specific vacuum cleaner.
- Clean with the vacuum cleaner the floors of the E.U.1,
E.U.2, E.U.3, and E.U.4.
- Bring the vacuum cleaner outside the cleanroom, passing
through the E.U.3, and empty it.
- Sterilize the vacuum cleaner in the E.U.3, and store it in
the E.U.4.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4
Daily /
After final
production /
Monthly /
Quarterly
Cleaner
Chapter 8
160
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.3.3
Clean doors,
windows and
recovering grids
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary products and
equipment.
- Clean with the specific products doors, widows and
recovering grids of the E.U.1, E.U.2, E.U.3, and E.U.4.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4
Daily /
After final
production /
Before new
production /
Monthly /
Quarterly
Cleaner
A.3.4 Clean the walls
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary equipment.
- Isolate all electrical parts of machines with a tarp.
- Clean with the specific products the walls of the E.U.1,
E.U.2, E.U.3, and E.U.4.
- Bring the equipment outside the cleanroom, passing
through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4
After final
production /
Monthly /
Quarterly
Cleaner
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161
Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
A.3.5
Clean ceiling
and ceiling
lights
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary equipment.
- Isolate all electrical parts of machines.
- Clean with the specific products the ceiling and ceiling
lights of the E.U.1, E.U.2, E.U.3, and E.U.4.
- Bring the equipment outside the cleanroom, passing
through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4 Quarterly Cleaner
A.3.6 Clean filters
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary products and
equipment.
- Clean with the specific products all filters of the E.U.1.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4 Monthly Cleaner
Chapter 8
162
Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
T.4 Sanitization A.4.1
Sanitize doors,
windows, walls
and recovering
grids
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary equipment.
- Isolate all electrical parts of machines with a tarp.
- Clean with the specific products walls, windows, doors
and recovering grids of the E.U.1, E.U.2, E.U.3, and
E.U.4.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
After final
production /
Monthly /
Quarterly
Cleaner
A.4.2 Sanitize floors
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary equipment.
- Isolate all electrical parts of machines with a tarp.
- Clean with the specific products the floors of the E.U.1,
E.U.2, E.U.3, and E.U.4.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
Daily /
After final
production /
Before new
production /
Monthly /
Quarterly
Cleaner
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163
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.4.3
Sanitize
equipment and
machines
- Enter in the E.U.3, bring the necessary products and
equipment and sterilize them.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 and take the necessary products and
equipment.
- Isolate all electrical parts of machines with a tarp.
- Clean with the specific products all equipment and
machines of the E.U.1, E.U.2, E.U.3, and E.U.4.
- Bring the products and equipment used outside the
cleanroom, passing through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
Daily /
After final
production /
Before new
production /
Monthly /
Quarterly
Cleaner
T.5 Control A.5.1
Control the
correct
functioning of
doors
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Control the electronic opening of the doors of the E.U.1,
E.U.2, E.U.3, and E.U.4, ensuring the correct functioning
of the alarm systems.
- In case of damages, follow the procedure of
extraordinary maintenance, calling the external
maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4 Daily Technician
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164
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
A.5.2 Control filters
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Control the correct functioning of filters of the E.U.1.
- In case of damages, follow the procedure of extraordinary
maintenance, calling the external maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3 Weekly Technician
A.5.3
Control the
insulation
components
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Control the insulation components of the E.U.1, E.U.2,
E.U.3, and E.U.4.
- In case of damages, follow the procedure of extraordinary
maintenance, calling the external maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4 Daily Technician
A.5.4
Control doors,
windows, walls,
floors, and
ceiling
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Control the doors, windows, walls, floors and ceiling of
the E.U.1, E.U.2, E.U.3, and E.U.4.
- In case of damages, follow the procedure of extraordinary
maintenance, calling the external maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4 Daily Technician
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165
Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
A.5.5
Control
magnehelic
systems
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Control the correct functioning of the magnehelic systems
of the E.U.1, E.U.2, E.U.3, and E.U.4.
- In case of damages, follow the procedure of extraordinary
maintenance, calling the external maintenance worker.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3
– E.U.4 Daily Technician
T.6 Substitution A.6.1
Substitution of
insulation
components
- Enter in the E.U.3, bring all materials and equipment
necessary for the ceiling lights substitution and sterilize
them, removing possible packages.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 to take the necessary materials and
equipment sterilized.
- Enter in the E.U.1 and disassemble the old insulation
components, putting them into a package.
- Clean and sterilize the area, with a cloth moistened with
alcohol.
- Assemble the new insulation components.
- Bring old components outside cleanroom, passing
through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3 Annually Technician
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166
Task Activity
Execution Environmental Unit Frequency Executor Code Description Code Description
A.6.2 Substitution of
filters
- Enter in the E.U.3, bring all materials and equipment
necessary for the filter substitution and sterilize them,
removing possible packages.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 to take the necessary materials and
equipment sterilized.
- Enter in the E.U.1 and disassemble the old filters, putting
them into a package.
- Clean and sterilize the area, with a cloth moistened with
alcohol.
- Assemble the new filters, controlling their functioning.
- Bring old filters outside cleanroom, passing through the
E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
E.U.1 – E.U.2 – E.U.3 Annually Technician
A.6.3 Substitution of
ceiling lights
- Enter in the E.U.3, bring all materials and equipment
necessary for the insulation components substitution and
sterilize them, removing possible packages.
- Enter in the E.U.2 and perform the dressing procedure,
wearing the following sanitary devices: gloves, mask,
tracksuit, headdress, and booties.
- Enter in the E.U.3 to take the necessary materials and
equipment sterilized.
- Enter in the E.U.1 and disassemble the old ceiling lights,
putting them into a package.
- Clean and sterilize the area, with a cloth moistened with
alcohol.
E.U.1 – E.U.2 – E.U.3 Annually Technician
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167
Task Activity Execution Environmental Unit Frequency Executor
Code Description Code Description
- Assemble the new ceiling lights.
- Bring old components outside cleanroom, passing
through the E.U.3.
- Compile the module of maintenance activity for the
registration of data and information about cleanroom
maintenance.
Table 8.3: Aerosol Service Italiana S.r.l. maintenance activities.
Chapter 8
168
8.4 Maintenance risk factors: the micro-contamination hazard
The last passage of the analysis aims to examine every single step of each maintenance
activity, to highlights and understand possible risks factors, and indicate one or more
possible solutions.
This analysis allows to obtain different information about maintenance, among which a
list of possible risks, which can occur during the execution of maintenance.
The possible risks are the following:
Risk Description
Micro-contamination Contamination generated by micro particles, which are defined as particle with
dimension between 0.1 and 100 µm.
Macro-contamination Contamination generated by macro particles, which are defined as particles
visible to the naked eye.
Environmental contamination Contamination, which affects the environmental parameters of the cleanroom
as pressure, humidity, and temperature.
Generation of immune
microorganisms
Microscopic organisms, which become resistant and immune to detergents,
after a frequent use of the same cleaning products.
Mismanagement Bad management of maintenance activity, which can occur when the company
does not provide maintenance documentation, the personnel does not compile
the documentation or when extraordinary maintenance procedures are not
followed.
Organisational inefficiency Inadequate or absent managerial efficiency, caused by the not-transmission of
maintenance information or by an inadequate management of maintenance
activities.
No feedback information Absence of transmission or exchange of maintenance information,
fundamental for the development and improvement of maintenance
organisation.
Standard violation Non-compliance with standards about the sort of normal and special waste and
production residuals.
Spatial inefficiency Inefficiency caused by lack of an adequate space where perform maintenance,
or absence of necessary space where store the necessary equipment.
Electronic failure Termination of the ability of an electronic item to perform a required function,
generated by inexperience of maintenance worker, non-fulfilment of
maintenance activities, or non-respect of maintenance procedures.
Item failure Termination of the ability of an item to perform a required function, generated
by inexperience of maintenance worker, non-fulfilment of maintenance
activities, or non-respect of maintenance procedures.
Item obsolescence Inability of an item to be maintained due to the unavailability on the market
of the necessary resources at acceptable technical and/or economic conditions,
caused by inexperience of maintenance worker, non-fulfilment of
maintenance activities, or non-respect of maintenance procedures.
Item degradation Detrimental change in physical condition, with time, use or external cause of
an item, caused by inexperience of maintenance worker, non-fulfilment of
maintenance activities, or non-respect of maintenance procedures.
System malfunctioning Malfunctioning of systems caused by inexperience of maintenance worker,
non-fulfilment of maintenance activities, or non-respect of maintenance
procedures.
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169
Structural malfunctioning Malfunctioning of the structure generated by inexperience of maintenance
worker, non-fulfilment of maintenance activities, or non-respect of
maintenance procedures.
Equipment malfunctioning Malfunctioning of the equipment caused by inexperience of maintenance
worker, non-fulfilment of maintenance activities, or non-respect of
maintenance procedures.
Table 8.4: Aerosol Service Italiana S.r.l. maintenance risks.
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170
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.1.1
Empty the
machine
plans
S.1.1.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.1.1.2
Enter in the
E.U.1 and pick
up waste and
macro
residuals from
the machine
plans.
Micro-
contamination
Macro-
contamination
Worker does not
collect all waste and
macro residuals,
leaving
contamination.
Request a visual
control after the
maintenance
activity.
Provide a form to
fill, to be used as
control check list
after the
maintenance
activity.
S.1.1.3
Sort waste and
residuals in the
opposite
containers.
Worker does not
know how to sort the
pharmaceutical waste
and residuals into
different containers.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide specific
containers where
sort the waste and
residuals.
Instruct personnel
about the sort of
waste, organizing
a training course.
Guarantee the
supply of
specific
containers for
the disposal of
waste and
residuals.
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171
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.1.1.4
Bring all the
residuals and
waste outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.1.1.5
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.1.2
Removal of
material and
equipment
S.1.2.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
Micro-
contamination
Macro-
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
Instruct personnel
about dressing
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
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172
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Environmental
contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
headdresses, and
booties.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
quantity of
them.
information
plaque about
dressing
procedure.
S.1.2.2
Enter the
E.U.1 and pick
up all
materials and
equipment
used during
the
production.
Micro-
contamination
Macro-
contamination
Worker does not
collect all materials
and equipment used
during production,
leaving
contamination.
Request a visual
control after the
maintenance
activity.
Provide a form to
fill, to be used as
control check list
after the
maintenance
activity.
S.1.2.3
Clean with a
cloth all
equipment
used during
the production
and stores it
into the E.U.4.
Micro-
contamination
Macro-
contamination
Spatial
inefficiency
Worker does not
know the correct
procedure for
cleaning and use
wrong products and
equipment, generating
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide a correct
supply of sterilized
cloth.
Organisation does
not design the
correct space, where
store all equipment
in the storage room.
Instruct personnel
about cleaning
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of sterilized
cloths, stocking
up a minimum
quantity of
them.
Install an opposite
wardrobe, where
store sterilized
cloths, positioning
it in the storage
room.
Install wardrobes
and shelfs in the
storage room,
where store the
necessary
equipment.
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173
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.1.2.4
Bring all the
materials
outside the
cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.1.2.5
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.1.3
Empty the
garbage
containers
S.1.3.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
Micro-
contamination
Macro-
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
Instruct personnel
about dressing
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
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174
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Environmental
contamination
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
headdresses, and
booties.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
quantity of
them.
plaque about
dressing
procedure.
S.1.3.2
Enter in the
E.U.1 and pick
up all garbage
containers,
sealing them.
Micro-
contamination
Macro-
contamination
Worker does not put
the covers on the
garbage containers,
generating micro and
macro contamination
during their transport.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide correct
garage containers
with the hermetic
cover.
Instruct personnel
about the correct
procedure about
the closure of
garbage
containers.
Supply the
cleanroom with
the specific
garbage
containers,
equipped with
hermetic covers.
S.1.3.3
Bring the
garbage
containers
outside the
cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take garbage
container outside the
cleanroom without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about the correct
procedure,
organizing a
training course.
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175
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.1.3.4
Sort garbage
into different
containers.
Spatial
inefficiency
Standard
violation
Worker does not
know the standards
about the sort of
garbage into different
containers.
Organisation does not
plan any training
course for personnel.
Organisation does
not provide the
correct containers,
where store garbage
according to
pharmaceutical
standards.
Instruct personnel
about the sort of
garbage
procedure,
organizing a
training course.
Purchase the
correct garbage
containers,
according to the
pharmaceutical
standards.
Design the
specific area
outside the
cleanroom, where
position the
garbage
containers.
S.1.3.5
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.2.1
Removal of
macro-
contamination
S.2.1.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
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176
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
headdress, and
booties.
Organisation does not
plan any training
course for personnel
education.
explanation of the
dressing
procedure.
S.2.1.2
Enter in the
E.U.4 and take
the specific
vacuum
cleaner.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and bring a
vacuum cleaner from
the outside,
generating micro and
macro contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply the
cleanroom with a
dedicated vacuum
cleaner.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Purchase a
vacuum cleaner
used only in the
cleanroom and
execute its
maintenance
monthly.
S.2.1.3
Enter in the
E.U.1 and
clean with the
vacuum
cleaner all the
machines and
equipment
used during
the
production.
Micro-
contamination
Macro-
contamination
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Chapter 8
177
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.2.1.4
Bring the
vacuum
cleaner
outside the
cleanroom,
passing
through the
E.U.3, and
empty it.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take garbage
containers outside the
cleanroom without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.2.1.5
Sterilize the
vacuum
cleaner in the
E.U.3, and
store it in the
E.U.4.
Micro-
contamination
Macro-
contamination
Spatial
inefficiency
Worker does not
know the correct
procedure and take
the vacuum cleaner
inside the cleanroom
without sterilize it
after the use. This can
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not design the
correct space, where
store the vacuum
cleaner in the E.U.4.
Instruct personnel
about the correct
procedure about
sterilization of the
vacuum cleaner.
Design a
dedicated space in
the storage room
for the vacuum
cleaner.
S.2.1.6
Compile the
module of
maintenance
activity for the
Mismanagement
Organisational
inefficiency
Worker does not
know the correct
procedure for
maintenance activity
Organisation does
not provide the
necessary
documentation and
Instruct personnel
about the
maintenance
procedure,
Create an
information
system for the
management of
Chapter 8
178
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
registration of
data and
information
about
cleanroom
maintenance.
No feedback
information
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
modules for the
registration of
maintenance
activities and the
collection of data
and information.
providing the
necessary
modules for the
registration of
maintenance
activities.
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.2.2
Clean the
internal parts
of machines
S.2.2.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.2.2.2
Enter in the
E.U.1 and
isolate the
electric parts
of the
machines with
a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
Chapter 8
179
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does not
plan any training
course for personnel
education.
S.2.2.3
Blow with
compressed
air all internal
parts of
machines.
Macro-
contamination
Organisation does
not predispose and
install the necessary
components for the
compressed air.
Design the
necessary space
and components
for the installation
of compressed air.
S.2.2.4
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.2.3
Clean all
parts of
machines
S.2.3.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
Chapter 8
180
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
sterilization of
products in the
E.U.3.
S.2.3.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.2.3.3
Enter in the
E.U.3 and take
the necessary
products and
equipment.
Chapter 8
181
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.2.3.4
Enter in the
E.U.1 and
isolate the
electric parts
of the
machines with
a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Organisation does not
plan any training
course for personnel
education.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
S.2.3.5
Clean with a
cloth
moistened
with alcohol
all parts of
machines.
Micro-
contamination
Macro-
contamination
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course.
S.2.3.6
Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Chapter 8
182
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.2.3.7
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.2.4
Clean
cabinets and
benches
S.2.4.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
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183
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
and equipment
coming from
outside.
equipment for
the sterilization
of products
coming from
outside.
S.2.4.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.2.4.3
Enter in the
E.U.3 and take
the necessary
products and
equipment.
S.2.4.4
Enter in the
E.U.2 and
clean
internally and
externally all
cabinets.
Then, clean all
benches.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
micro
contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Guarantee a
supply of
different
cleaning
products,
interchanging
them biweekly.
Chapter 8
184
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.2.4.5
Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.2.4.6
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.3.1
Clean all
floors with
the specific
broom
S.3.1.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
Micro-
contamination
Macro-
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
Chapter 8
185
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Environmental
contamination
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
headdresses, and
booties.
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
quantity of
them.
plaque about
dressing
procedure.
S.3.1.2
Enter in the
E.U.4 and take
the specific
broom.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and bring a
broom from the
outside, generating
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply the
cleanroom with a
dedicated broom.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Purchase a
broom used only
in the cleanroom
and organize its
substitution
weekly.
S.3.1.3
Clean with the
specific
products and
the broom the
floors of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Materials used for
the floor
construction allows
the generation of
particles, are not
easily cleanable,
water resistant,
durable, chemically
inert, antistatic and
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of cleaning
products,
stocking up a
minimum
quantity of
them.
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Choose materials
of construction
with the following
characteristics:
- capacity to not
generate particles;
- capacity to be
easily cleaned;
Chapter 8
186
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
does not have an
airtight structure.
This does not allow
a correct cleaning
and generate the risk
of micro and macro
contamination.
- capacity to resist
to water,
detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have
an airtight
structure.
S.3.1.4
Sterilize the
broom in the
E.U.3, and
store it in the
E.U.4.
Micro-
contamination
Macro-
contamination
Spatial
inefficiency
Worker does not
know the correct
procedure and take
the broom inside the
cleanroom without
sterilize it after the
use. This can generate
the risk of micro and
macro contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not design the
correct space, where
store the vacuum
cleaner in the E.U.4.
Instruct personnel
about the correct
procedure about
sterilization of the
vacuum cleaner.
Design a
dedicated space in
the storage room
for the vacuum
cleaner.
S.3.1.5
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
Chapter 8
187
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
cleanroom
maintenance.
Organisation does not
plan any training
course for personnel
education.
collection of data
and information.
maintenance
activities.
manage all
information about
maintenance,
improving it.
A.3.2
Clean all
floors with
the vacuum
cleaner
S.3.2.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.3.2.2
Enter in the
E.U.4 and take
the specific
vacuum
cleaner
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and bring a
vacuum cleaner from
the outside,
generating micro and
macro contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply the
cleanroom with a
dedicated vacuum
cleaner.
Instruct personnel
about the correct
procedure,
organizing a
training course.
Purchase a
vacuum cleaner
used only in the
cleanroom and
execute its
maintenance
monthly.
Chapter 8
188
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.2.3
Clean with the
vacuum
cleaner the
floors of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the correct
procedure,
organizing a
training course
S.3.2.4
Bring the
vacuum
cleaner
outside the
cleanroom,
passing
through the
E.U.3, and
empty it.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.3.2.5
Sterilize the
vacuum
cleaner in the
E.U.3, and
store it in the
E.U.4.
Micro-
contamination
Macro-
contamination
Spatial
inefficiency
Worker does not
know the correct
procedure and take
the vacuum cleaner
inside the cleanroom
without sterilize it
after the use. This can
generate the risk of
micro and macro
contamination.
Organisation does
not design the
correct space, where
store the vacuum
cleaner in the E.U.4.
Instruct personnel
about the correct
procedure about
sterilization of the
vacuum cleaner.
Design a
dedicated space in
the storage room
for the vacuum
cleaner.
Chapter 8
189
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Organisation does not
plan any training
course for personnel
education.
S.3.2.6
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.3.3
Clean doors,
windows and
recovering
grids
S.3.3.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
Chapter 8
190
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
coming from
outside.
of products
coming from
outside.
S.3.3.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.3.3.3
Enter in the
E.U.3 and take
the necessary
products and
equipment.
S.3.3.4
Clean with the
specific
products
doors, widows
and recovering
grids of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Materials used for
the floor
construction allows
the generation of
particles, are not
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Choose materials
of construction
with the following
characteristics:
Chapter 8
191
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
easily cleanable,
water resistant,
durable, chemically
inert, antistatic and
does not have an
airtight structure.
This does not allow
a correct cleaning
and generate the risk
of micro and macro
contamination.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
micro
contamination.
use of different
products
biweekly.
- capacity to not
generate particles;
- capacity to be
easily cleaned;
- capacity to resist
to water,
detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have
an airtight
structure.
S.3.3.5
Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
Chapter 8
192
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.3.6
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.3.4 Clean the
walls S.3.4.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
Chapter 8
193
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.4.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.3.4.3 Enter in the
E.U.3 and take
the necessary
products and
equipment.
S.3.4.4
Isolate all
electrical parts
of machines
with a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Organisation does not
plan any training
course for personnel
education.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
Chapter 8
194
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.4.5
Clean with the
specific
products the
walls of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Materials used for
the floor
construction allows
the generation of
particles, are not
easily cleanable,
water resistant,
durable, chemically
inert, antistatic and
does not have an
airtight structure.
This does not allow
a correct cleaning
and generate the risk
of micro and macro
contamination.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
micro
contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
use of different
products
biweekly.
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Choose materials
of construction
with the following
characteristics:
- capacity to not
generate particles;
- capacity to be
easily cleaned;
- capacity to resist
to water,
detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have
an airtight
structure.
Chapter 8
195
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.4.6
Bring the
equipment
outside the
cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.3.4.7
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.3.5
Clean ceiling
and ceiling
lights
S.3.5.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
Chapter 8
196
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
organizing
training courses.
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
S.3.5.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.3.5.3
Enter in the
E.U.3 and take
the necessary
equipment.
Chapter 8
197
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.5.4
Isolate all
electrical parts
of machines
with a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Organisation does not
plan any training
course for personnel
education.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
S.3.5.5
Clean with the
specific
products the
ceiling and
ceiling lights
of the E.U.1,
E.U.2, E.U.3,
and E.U.4.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Materials used for
the floor
construction allows
the generation of
particles, are not
easily cleanable,
water resistant,
durable, chemically
inert, antistatic and
does not have an
airtight structure.
This does not allow
a correct cleaning
and generate the risk
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
use of different
products
biweekly.
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Choose materials
of construction
with the following
characteristics:
- capacity to not
generate particles;
- capacity to be
easily cleaned;
- capacity to resist
to water,
detergents and
disinfectants;
Chapter 8
198
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
of micro and macro
contamination.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
micro
contamination.
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have
an airtight
structure.
S.3.5.6
Bring the
equipment
outside the
cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
Chapter 8
199
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.5.7
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.3.6 Clean filters S.3.6.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
Chapter 8
200
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.3.6.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.3.6.3
Enter in the
E.U.3 and take
the necessary
products and
equipment.
S.3.6.4
Clean with the
specific
products all
filters of the
E.U.1.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker is not able to
clean filters, due to
the inaccessibility to
them. Indeed, filters
can be positioned in
unattainable points or
can be barrier which
impede their
accessibility.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
use of different
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Position filters
where it is
possible to
execute their
maintenance
easily, without
Chapter 8
201
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
micro
contamination.
products
biweekly.
barriers, which
can impede their
accessibility.
S.3.6.5
Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.3.6.6
Compile the
module of
maintenance
activity for the
registration of
data and
information
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
Chapter 8
202
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
about
cleanroom
maintenance.
Organisation does not
plan any training
course for personnel
education.
activities and the
collection of data
and information.
registration of
maintenance
activities.
collect and
manage all
information about
maintenance,
improving it.
A.4.1
Sanitize
doors,
windows,
walls and
recovering
grids
S.4.1.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
S.4.1.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
Micro-
contamination
Macro-
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
Chapter 8
203
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Environmental
contamination
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
headdresses, and
booties.
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
quantity of
them.
plaque about
dressing
procedure.
S.4.1.3
Enter in the
E.U.3 and take
the necessary
equipment.
S.4.1.4
Isolate all
electrical parts
of machines
with a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Organisation does not
plan any training
course for personnel
education.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
Chapter 8
204
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.1.5
Clean with the
specific
products
walls,
windows,
doors and
recovering
grids of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Materials used for
the floor
construction allows
the generation of
particles, are not
easily cleanable,
water resistant,
durable, chemically
inert, antistatic and
does not have an
airtight structure.
This does not allow
a correct cleaning
and generate the risk
of micro and macro
contamination.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
micro
contamination.
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
use of different
products
biweekly.
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Choose materials
of construction
with the following
characteristics:
- capacity to not
generate particles;
- capacity to be
easily cleaned;
- capacity to resist
to water,
detergents and
disinfectants;
- durability;
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have
an airtight
structure.
Chapter 8
205
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.1.6
Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.4.1.7
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.4.2 Sanitize
floors S.4.2.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
Chapter 8
206
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Environmental
contamination
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
organizing
training courses.
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
S.4.2.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.4.2.3
Enter in the
E.U.3 and take
the necessary
equipment.
Chapter 8
207
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.2.4
Isolate all
electrical parts
of machines
with a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Organisation does not
plan any training
course for personnel
education.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
S.4.2.5
Clean with the
specific
products the
floors of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Materials used for
the floor
construction allows
the generation of
particles, are not
easily cleanable,
water resistant,
durable, chemically
inert, antistatic and
does not have an
airtight structure.
This does not allow
a correct cleaning
and generate the risk
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
use of different
products
biweekly.
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
Choose materials
of construction
with the following
characteristics:
- capacity to not
generate particles;
- capacity to be
easily cleaned;
- capacity to resist
to water,
detergents and
disinfectants;
- durability;
Chapter 8
208
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
of micro and macro
contamination.
The use of the same
cleaning product
can generate
immune
microorganisms,
able to resist to these
products. This
generate the risk of
micro
contamination.
- capacity to be
chemically inert;
- capacity to be
antistatic;
- capacity to have
an airtight
structure.
S.4.2.6 Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
Chapter 8
209
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.2.7 Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.4.3
Sanitize
equipment
and machines
S.4.3.1
Enter in the
E.U.3, bring
the necessary
products and
equipment and
sterilize them.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the correct
cleaning products
and equipment for
the correct
execution of the
maintenance
activity.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of cleaning
products and
equipment,
stocking up a
minimum
quantity of them
in a dedicated
warehouse
outside the
cleanroom.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Design a
dedicated
warehouse for the
cleaning products
and equipment for
the cleanroom,
positioned outside
it.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
Chapter 8
210
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.3.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.4.3.3
Enter in the
E.U.3 and take
the necessary
products and
equipment.
S.4.3.4
Isolate all
electrical parts
of machines
with a tarp.
Electronic
failure
Worker does not
know the correct
procedure and does
not isolate machines.
Organisation does not
plan any training
course for personnel
education.
Worker does not have
the necessary space to
move and cover the
electric part of
machines.
Organisation does
not purchase the
necessary material
to cover the
machines.
Instruct personnel
about the correct
isolation
procedure.
Purchase tarps
of sufficient
dimension to
cover the
machines.
Design the
sufficient space
around machines,
to allow a correct
movement and
accessibility to
isolate them.
Chapter 8
211
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.3.5
Clean with the
specific
products all
equipment and
machines of
the E.U.1,
E.U.2, E.U.3,
and E.U.4.
Micro-
contamination
Macro-
contamination
Generation of
immune
microorganisms
Worker does not clean
in the correct and
deepened way,
generating the risk of
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with necessary
products for the
cleanroom cleaning.
Instruct personnel
about the correct
procedure,
organizing a
training course
Guarantee a
sufficient supply
of different
cleaning
products,
stocking up a
minimum
quantity of
them. In
addition,
interchange the
use of different
products
biweekly.
Design and
organize the
necessary space in
the E.U.4 for the
storage of
cleaning products.
S.4.3.6
Bring the
products and
equipment
used outside
the cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
Chapter 8
212
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.4.3.7
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.5.1
Control the
correct
functioning of
doors
S.5.1.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
Chapter 8
213
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.1.2
Control the
electronic
opening of the
doors of the
E.U.1, E.U.2,
E.U.3, and
E.U.4,
ensuring the
correct
functioning of
the alarm
systems.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Item failure
Item
obsolescence
Item
degradation
Worker does not
know the mode of
operation of the
electronic
components of doors.
On consequence, he is
not able to control the
correct functioning of
them.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not install electronic
systems for the
control of the
opening of doors.
Doors opened
together can cause
the risk of macro
and micro
contamination or the
risk of variation of
the cleanroom
environmental
conditions
(temperature,
humidity, and
pressure).
Organisation does
not choose high
quality components.
On consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Instruct personnel
about the
functioning of
electronic systems
of doors,
organizing a
training course.
Install electronic
systems with
alarms for the
control of the
opening of doors.
This impede the
simultaneously
opening of doors.
Choose high
quality
components,
which are
available, reliable
and durable.
Chapter 8
214
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.1.3
In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and try
to repair possible
damages, causing a
failure in the system.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the
procedure of
extraordinary
maintenance,
organising a
training course
and provide the
necessary
documentation for
the opening of
procedure.
Establish a
technical
agreement with an
external
organization for
the provision of
extraordinary
maintenance
works.
S.5.1.4
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.5.2 Control filters S.5.2.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
Chapter 8
215
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
gloves, mask,
tracksuit,
headdress, and
booties.
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
dressing
procedure.
S.5.2.2
Control the
correct
functioning of
filters of the
E.U.1.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Item failure
Item
obsolescence
Item
degradation
Worker does not
know the functioning
of filters and he is not
able to control their
operation.
Organisation does not
plan any training
course for personnel
education.
Worker is not able to
control filters, due to
the inaccessibility to
them. Indeed, filters
can be positioned in
unattainable points or
can be barrier which
impede their
accessibility.
Organisation does
not choose high
quality components.
On consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Instruct personnel
about the
functioning of
filters, organizing
a training course.
Position filters
where it is
possible to
execute their
maintenance
easily, without
barriers, which
can impede their
accessibility.
Choose high
quality
components,
which are
available, reliable
and durable.
S.5.2.3
In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and try
to repair possible
damages, causing a
failure in the system.
Instruct personnel
about the
procedure of
extraordinary
maintenance,
organising a
training course
and provide the
Establish a
technical
agreement with an
external
organization for
the provision of
extraordinary
Chapter 8
216
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
maintenance
worker.
Organisation does not
plan any training
course for personnel
education.
necessary
documentation
for the opening of
procedure.
maintenance
works.
S.5.2.4
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.5.3
Control the
insulation
components
S.5.3.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
Chapter 8
217
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.3.2
Control the
insulation
components of
the E.U.1,
E.U.2, E.U.3,
and E.U.4.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Item failure
Item
obsolescence
Item
degradation
Organisation does
not choose high
quality components.
On consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Choose high
quality
components,
which are
available, reliable
and durable.
S.5.3.3
In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and try
to repair possible
damages, causing a
failure in the system.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the
procedure of
extraordinary
maintenance,
organising a
training course
and provide the
necessary
documentation for
the opening of
procedure.
Establish a
technical
agreement with an
external
organization for
the provision of
extraordinary
maintenance
works.
Chapter 8
218
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.3.4
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.5.4
Control
doors,
windows,
walls, floors,
and ceiling
S.5.4.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
Chapter 8
219
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.5.4.2
Control the
doors,
windows,
walls, floors
and ceiling of
the E.U.1,
E.U.2, E.U.3,
and E.U.4.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Item failure
Item
obsolescence
Item
degradation
Organisation does
not choose high
quality components.
On consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Choose high
quality
components,
which are
available, reliable
and durable.
S.5.4.3
In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and try
to repair possible
damages, causing a
failure in the system.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the
procedure of
extraordinary
maintenance,
organising a
training course
and provide the
necessary
documentation for
the opening of
procedure.
Establish a
technical
agreement with an
external
organization for
the provision of
extraordinary
maintenance
works.
S.5.4.4
Compile the
module of
maintenance
activity for the
registration of
Mismanagement
Organisational
inefficiency
Worker does not
know the correct
procedure for
Organisation does
not provide the
necessary
documentation and
modules for the.
Instruct personnel
about the
maintenance
procedure,
providing the
Create an
information
system for the
management of
maintenance
Chapter 8
220
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
data and
information
about
cleanroom
maintenance.
No feedback
information
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
registration of
maintenance
activities and the
collection of data
and information
necessary
modules for the
registration of
maintenance
activities.
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.5.5
Control
magnehelic
systems
S.5.5.1
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
S.5.5.2
Control the
correct
functioning of
the
magnehelic
systems of the
E.U.1, E.U.2,
E.U.3, and
E.U.4.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Item failure
Worker does not
know the functioning
of magnehelic
systems and he is not
able to control their
operation.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not choose high
quality components.
On consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
Instruct personnel
about the
functioning of
magnehelic,
organizing a
training course.
Position
magnehelic
system outside
cleanrooms doors,
where it is
possible to read
the environmental
parameters and
execute their
Chapter 8
221
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
Item
obsolescence
Item
degradation
Worker is not able to
control magnehelic
systems, due to the
inaccessibility to
them. Indeed, they
can be positioned in
unattainable points or
can be barrier which
impede their
accessibility.
the necessity of a
frequent
maintenance.
maintenance
easily.
Choose high
quality
components,
which are
available, reliable
and durable.
S.5.5.3
In case of
damages,
follow the
procedure of
extraordinary
maintenance,
calling the
external
maintenance
worker.
Mismanagement
Item failure
Worker does not
know the correct
procedure for
extraordinary
maintenance and try
to repair possible
damages, causing a
failure in the system.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the
procedure of
extraordinary
maintenance,
organising a
training course
and provide the
necessary
documentation for
the opening of
procedure.
Establish a
technical
agreement with an
external
organization for
the provision of
extraordinary
maintenance
works.
S.5.5.4
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
Chapter 8
222
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
A.6.1
Substitution
of insulation
components
S.6.1.1
Enter in the
E.U.3, bring
all materials
and equipment
necessary for
the ceiling
lights
substitution
and sterilize
them,
removing
possible
packages.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
S.6.1.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
dressing
procedure.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
dressing
procedure.
Chapter 8
223
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.6.1.3
Enter in the
E.U.3 to take
the necessary
materials and
equipment
sterilized.
S.6.1.4
Enter in the
E.U.1 and
disassemble
the old
insulation
components,
putting them
into a package.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and does
not put the
contaminated and old
insulation
components into a
package, after having
disassembled it. This
can generate micro
and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging
materials outside
the cleanroom,
where store the
necessary
materials.
S.6.1.5
Clean and
sterilize the
area, with a
cloth
moistened
with alcohol.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and does
not sterilize the area
of intervention. This
can generate the risk
of macro and micro
contamination.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the correct
procedure of
sterilization,
organizing a
training course.
Chapter 8
224
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.6.1.6
Assemble the
new insulation
components.
Structural
malfunctioning
Organisation does
not choose high
quality insulation
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Choose high
quality
components,
which are
available, reliable
and durable.
S.6.1.7
Bring old
components
outside
cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.6.1.8 Compile the
module of
maintenance
activity for the
registration of
Mismanagement
Organisational
inefficiency
Worker does not
know the correct
procedure for
Organisation does
not provide the
necessary
documentation and
modules for the
Instruct personnel
about the
maintenance
procedure,
providing the
Create an
information
system for the
management of
maintenance
Chapter 8
225
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
data and
information
about
cleanroom
maintenance.
No feedback
information
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
registration of
maintenance
activities and the
collection of data
and information.
necessary
modules for the
registration of
maintenance
activities.
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.6.2 Substitution
of filters S.6.2.1
Enter in the
E.U.3, bring
all materials
and equipment
necessary for
the filter
substitution
and sterilize
them,
removing
possible
packages.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
S.6.2.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
following
sanitary
devices:
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
generating micro and
macro contamination
for the environment
and the entire
production.
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
headdresses, and
booties.
Instruct personnel
about dressing
procedure,
organizing a
training course.
Position an
information
plaque at the
entrance of the
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
information
plaque about
Chapter 8
226
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
gloves, mask,
tracksuit,
headdress, and
booties.
Organisation does not
plan any training
course for personnel
education.
E.U.2, with a
detailed
explanation of the
procedure.
dressing
procedure.
S.6.2.3
Enter in the
E.U.3 to take
the necessary
materials and
equipment
sterilized.
S.6.2.4
Enter in the
E.U.1 and
disassemble
the old filters,
putting them
into a package.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and does
not put the
contaminated and old
filters into a package,
after having
disassembled it. This
can generate micro
and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging
materials outside
the cleanroom,
where store the
necessary
materials.
S.6.2.5
Clean and
sterilize the
area, with a
cloth
moistened
with alcohol.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and does
not sterilize the area
of intervention. This
can generate the risk
Instruct personnel
about the correct
procedure of
sterilization,
organizing a
training course.
Chapter 8
227
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
of macro and micro
contamination.
Organisation does not
plan any training
course for personnel
education.
S.6.2.6
Assemble the
new filters,
controlling
their
functioning.
System
malfunctioning
Organisation does
not choose high
quality insulation
components. On
consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Choose high
quality
components,
which are
available, reliable
and durable.
S.6.2.7
Bring old
filters outside
cleanroom,
passing
through the
E.U.3.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Install an
information
plaque in the
cleanroom,
indicating the
exits.
Instruct personnel
about exit
procedure,
organizing a
training course.
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Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.6.2.8
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
A.6.3
Substitution
of ceiling
lights
S.6.3.1
Enter in the
E.U.3, bring
all materials
and equipment
necessary for
the insulation
components
substitution
and sterilize
them,
removing
possible
packages.
Micro-
contamination
Macro-
contamination
Environmental
contamination
Worker does not
know the correct
procedure and enters
in the cleanroom
without having
sterilized equipment
and products coming
from outside. This
generate the risk of
micro and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not supply worker
with the necessary
equipment for the
sterilization of
products, materials
and equipment
coming from
outside.
Instruct personnel
about the correct
procedure for the
introduction of
external materials
and equipment,
organizing
training courses.
Guarantee a
sufficient supply
of products and
equipment for
the sterilization
of products
coming from
outside.
Install a wardrobe
with the necessary
equipment for the
sterilization of
products in the
E.U.3.
S.6.3.2
Enter in the
E.U.2 and
perform the
dressing
procedure,
wearing the
Micro-
contamination
Macro-
contamination
Worker can enter in
the cleanroom without
wearing one or more
sanitary devices,
The organisation
does not provide an
adequate supply of
sanitary devices, as
gloves, masks,
tracksuits,
Instruct personnel
about dressing
procedure,
organizing a
training course.
Guarantee a
sufficient supply
of sanitary
devices,
stocking up a
minimum
Install a dedicated
wardrobe for
sanitary devices at
the entrance of the
E.U.2, positioned
next the
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Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
following
sanitary
devices:
gloves, mask,
tracksuit,
headdress, and
booties.
Environmental
contamination
generating micro and
macro contamination
for the environment
and the entire
production.
Organisation does not
plan any training
course for personnel
education.
headdresses, and
booties.
Position an
information
plaque at the
entrance of the
E.U.2, with a
detailed
explanation of the
procedure.
quantity of
them.
information
plaque about
dressing
procedure.
S.6.3.3
Enter in the
E.U.3 to take
the necessary
materials and
equipment
sterilized.
S.6.3.4
Enter in the
E.U.1 and
disassemble
the old
insulation
components,
putting them
into a package.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and does
not put the
contaminated and old
ceiling lights into a
package, after having
disassembled it. This
can generate micro
and macro
contamination.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide an
adequate supply of
materials for the
packaging of
disassembled
components.
Instruct personnel
about the correct
procedure of
packaging of
substituted
components,
organizing a
training course.
Supply
personnel with
the necessary
materials for
packaging,
stocking up a
minimum
quantity of
them.
Install a dedicated
wardrobe for
packaging
materials outside
the cleanroom,
where store the
necessary
materials.
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Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
S.6.3.5
Clean and
sterilize the
area, with a
cloth
moistened
with alcohol.
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure and does
not sterilize the area
of intervention. This
can generate the risk
of macro and micro
contamination.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about the correct
procedure of
sterilization,
organizing a
training course.
S.6.3.6
Assemble the
new ceiling
lights.
Structural
malfunctioning
Organisation does
not choose high
quality components.
On consequence,
perishability of
items is very high
and their life cycle
very short. This can
generate the risk of
failure of items and
the necessity of a
frequent
maintenance.
Choose high
quality
components,
which are
available, reliable
and durable.
S.6.3.7
Bring old
insulation
components
outside
cleanroom,
passing
Micro-
contamination
Macro-
contamination
Worker does not
know the correct
procedure for the exit
and take products and
equipment used for
the cleaning without
passing through
Install an
information
plaque in the
cleanroom,
indicating the
exits.
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231
Activity Step Risks
Risk factors Possible actions
Code Description Code Description Personnel Equipment Personnel Equipment Project
through the
E.U.3.
Environmental
contamination
E.U.3. This can
generate macro and
micro contamination.
Organisation does not
plan any training
course for personnel
education.
Instruct personnel
about exit
procedure,
organizing a
training course.
S.6.3.8
Compile the
module of
maintenance
activity for the
registration of
data and
information
about
cleanroom
maintenance.
Mismanagement
Organisational
inefficiency
No feedback
information
Worker does not
know the correct
procedure for
maintenance activity
registration and does
not compile the
module.
Organisation does not
plan any training
course for personnel
education.
Organisation does
not provide the
necessary
documentation and
modules for the
registration of
maintenance
activities and the
collection of data
and information.
Instruct personnel
about the
maintenance
procedure,
providing the
necessary
modules for the
registration of
maintenance
activities.
Create an
information
system for the
management of
maintenance
activities. This
allow to organize,
collect and
manage all
information about
maintenance,
improving it.
Table 8.5: Aerosol Service Italiana S.r.l. framework application.
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9. Framework validation and outcomes
The analysis of maintenance activities and steps, to find possible risks factors and solution
to them, has brought to the generation of a tool, which can be used for several different
applications.
The objective of this framework is to provide an instrument useful for a correct and
complete organisation of maintenance, considering all that factors, as requirements and
criticalities, which require a specific attention and consideration in respect to a general
maintenance. Indeed, as analysed in previous chapters, cleanrooms are controlled
environment, which have specific characteristics and requirements to be respected in
order to ensure the control of the environmental conditions and the respect of the product
necessities to be worked.
Important characteristic of the framework is its applicability to all typologies of
cleanroom, necessary to establish a common and useful tool, generally valid for every
sector. This characteristic emerges from a comparison between the application of the
framework on the two case studies, and its consequently validation.
The successive step consists in the analysis of the possible outcomes of this framework,
giving a concrete example of them. Indeed, exists several outcomes of this framework but
has been decided to take into consideration only two of them. Analysis proposed focus
the attention of the risks, elaborating them for maintenance activities and environmental
units. These applications illustrate the functionality of the framework and its applicability
to different cleanrooms typology.
9.1 Comparison between the case studies on the framework application
The aim of this framework is to provide a tool generally applicable to all type of
cleanrooms. Indeed, its modular structure can be used for different situations. Introducing
all data about any cleanroom maintenance, it is possible to obtain this basic framework.
The specificity of each cleanroom is outlined by the tool itself, thanks to the level of
detail, which requires a deepened analysis of each maintenance step. This allows to
identify possible risk factors and relative possible solutions, which are specific for the
case.
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From a comparison between the two case studies, is emerged that the framework is
applicable and functional for both. The two companies taken as example, belong to
different sectors, the mechanical engineering and the pharmaceutical one. As
demonstrated in the previous chapters, every sector has its specific characteristics
requirements and risks, which have to be considered and evaluated to guarantee the
quality and the correct execution of the manufacturing process.
The applicability of the framework to every cleanroom is evident from the fact that the
structure of the framework has not been modified between the two cases. The structure
of the tool is modular and has been developed considering basic information, easily
identifiable and recognizable in every cleanroom.
To correctly compile and structure the framework, it is necessary to start an analysis of
the cleanroom, considering module by module, its characteristics. Indeed, the first part of
the tool consists in the definition of basic information about maintenance tasks and
activities. The compilation of the first part of modules requires general data and allows
to have a global overview about cleanroom maintenance.
The second part of the tool consists in specific modules, which should be filled
considering possible risks and solutions about maintenance. These information are easily
obtainable because, the specificity of the module, requires a deepened analysis on
maintenance and bring to observe that each maintenance step can be subjected to a risk.
This allows to obtain a specific overview, which consider all possible aspect without
overlook any maintenance step.
The applicability to each cleanroom, as demonstrated with the case studies, is feasible
because the final information obtained derive from a way of thinking, which goes from
the general to the specific. The first general information required are easily reachable, and
the second part of them derive from a deepened analysis of the first.
The modular structure allows to change, if necessary, the structure of the tool, adding or
not, modules, according to specific requirements. Regardless, the structure of the tool
works for different cleanrooms and is applicable to each sector.
After the definition of the framework applicability, it is important to understand its
concrete outcomes and its efficiency about the management of cleanroom maintenance.
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234
For this reason, it is necessary to apply the framework according to different requirements
of each cleanroom and sector. Indeed, from this tool, it is possible to make several types
of analysis, which can be made through an elaboration of data obtained. Information
contained in the tool can be extrapolated, in order to find new data, useful for a correct
and efficient management and execution of maintenance.
9.2 Outcomes of the application of the framework in the mechanical
engineering sector
The first application of the framework aims to analysis maintenance activities according
to their riskiness. This analysis has been made considering the case study of Mako Shark
S.r.l., in order to analysis the impact of macro-contamination risk on the maintenance
activities of the mechanical engineering sector.
The goal is to consider all risk factors identified in each maintenance step, and, through
an elaboration of data, define which is the most frequent risk and which are the most
riskiness activities.
The utility of this application is to focus the attention on the most critic activities and, if
possible, to take preventive measure to reduce or avoid the probability of occurrence and
the impact of the major risk of the sector, the macro-contamination.
The first step consists in attributing a value to each maintenance activity, based on the
number of step that compose it. This means that, considering that each step has a value
of 1, a maintenance activity composed by 5 steps has a value of 5.
Maintenance activity Number of steps Activity value
A.1.1 Empty the machine plans 4 4
A.1.2 Removal of material and equipment 4 4
A.1.3 Empty the garbage containers 5 5
A.1.4 Removal of macro-contamination 6 6
A.2.1 Clean machines, equipment, mobile workstations,
and chairs
4 4
A.2.2 Clean freezers 4 4
A.2.3 Clean of garbage containers 5 5
A.3.1 Clean all floors with the specific broom 5 5
A.3.2 Clean all floors with the vacuum cleaner 6 6
A.3.3 Clean doors, windows and recovering grids 4 4
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A.3.4 Clean the walls 4 4
A.3.5 Clean ceiling and ceiling lights 4 4
A.3.6 Clean the entrance rubber mat 4 4
A.3.7 Clean filters 4 4
A.4.1 Control mobile workstation plans 4 4
A.4.2 Control filters 4 4
A.4.3 Control the insulation components 4 4
A.4.4 Control doors, windows, walls, floors, and ceiling 4 4
A.4.5 Control electronic systems 4 4
A.4.6 Control the joints of the vacuum system 4 4
A.5.1 Substitution of insulation components 6 6
A.5.2 Substitution of filters 6 6
A.5.3 Substitution of ceiling lights 6 6
A.5.4 Substitution of mobile workstation plans 6 6
Table 9.1: Mako Shark S.r.l. cleanroom activity value.
The second step consists in evaluating all risks identified for each step of each
maintenance activity. Giving to each risk a value of 1, the total value of risk for each
maintenance activity derives from how many steps can be affected by it. This means that
if an activity has 5 steps and in 3 of them exists the risk of macro-contamination, this risks
will have a value of 3.
This evaluation can be done for every risk identified by the framework. This analysis is
made taking into consideration one of the major risks: Macro-contamination.
Maintenance activity Risk value
A.1.1 Empty the machine plans 2
A.1.2 Removal of material and equipment 2
A.1.3 Empty the garbage containers 3
A.1.4 Removal of macro-contamination 5
A.2.1 Clean machines, equipment, mobile workstations, and chairs 3
A.2.2 Clean freezers 3
A.2.3 Clean of garbage containers 3
A.3.1 Clean all floors with the specific broom 4
A.3.2 Clean all floors with the vacuum cleaner 5
A.3.3 Clean doors, windows and recovering grids 3
A.3.4 Clean the walls 3
A.3.5 Clean ceiling and ceiling lights 3
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A.3.6 Clean the entrance rubber mat 1
A.3.7 Clean filters 3
A.4.1 Control mobile workstation plans 3
A.4.2 Control filters 2
A.4.3 Control the insulation components 2
A.4.4 Control doors, windows, walls, floors, and ceiling 2
A.4.5 Control electronic systems 2
A.4.6 Control the joints of the vacuum system 2
A.5.1 Substitution of insulation components 3
A.5.2 Substitution of filters 3
A.5.3 Substitution of ceiling lights 3
A.5.4 Substitution of mobile workstation plans 3
Table 9.2: Macro-contamination value for each maintenance activity.
Next step consists in match the two previous tables, multiplying each value of macro-
contamination for each maintenance activity.
This allows to obtain a value for each maintenance activity, based on its number of
maintenance steps and the macro-contamination value. The final result will be a ranking
table based on the macro-contamination risk, useful to focus the attention to some
activities, that will have a higher macro-contamination risk in respect to others.
Maintenance activity Activity value Risk value Final value
A.1.1 2 4 8
A.1.2 2 4 8
A.1.3 3 5 15
A.2.1 5 6 30
A.2.2 3 4 12
A.2.3 3 4 12
A.2.4 3 5 15
A.3.1 4 5 20
A.3.2 5 6 30
A.3.3 3 4 12
A.3.4 3 4 12
A.3.5 3 4 12
A.3.6 1 4 4
A.3.7 3 4 12
A.4.1 3 4 12
A.4.2 2 4 8
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A.4.3 2 4 8
A.4.4 2 4 8
A.4.5 2 4 8
A.4.6 2 4 8
A.5.1 3 6 18
A.5.2 3 6 18
A.5.3 3 6 18
A.5.4 3 6 18
Table 9.3: Maintenance activity value according to macro-contamination risk.
The final ranking of activities according to the macro-contamination risk is the
following:
Ranking Maintenance activity
1° A.2.1 / A.3.2
2° A.3.1
3° A.5.1 / A.5.2 / A.5.3 / A.5.4
4° A.1.3 / A.2.4 /
5° A.2.2 / A.2.3 / A.3.3 / A.3.4 /
A.3.5 / A.3.7 / A.4.1
6° A.1.1 / A.1.2 / A.4.2 / A.4.3 /
A.4.4 / A.4.5 / A.4.6
7° A.3.6
Table 9.4: Final maintenance activity ranking.
This final ranking highlights that activities A.2.1 “Clean machines, equipment, mobile
workstations, and chairs” and A.3.2 “A.3.2 Clean all floors with the vacuum cleaner”, are
those in which the risk of macro-contamination is the higher. This allows organisation to
take the necessary measure in order to reduce or avoid this risk.
From the framework defined in the previous chapter, it is possible to identify and analyse
risk factors and relative possible solutions associated to these activities, in order to
prevent macro-contamination and organize in the most adequate way these maintenances.
This analysis is made as example, in order to illustrate the concrete application of the
framework. Indeed, values of risks and steps are assumed to be equal to 1, in order to
simplify the explanation.
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238
A more deepened analysis allows to give a significant value to each data, attributing to
theme a weight. Indeed, the value of steps and risks can vary according to several factors
and cannot be assumed all equal to 1. Weights should be evaluated by organisation, based
on its priorities and decisions.
The following map allows to resume and understand the construction and the passages of
this analysis.
Figure 9.1: Schema of the analysis
9.3 Outcomes of the application of the framework in the pharmaceutical
sector
The second application of the framework aims to analysis cleanroom environmental units,
in regards to their riskiness. The objective is to consider environmental units and the
maintenance activity steps performed in them, in order to understand which is the riskiest
area.
The analysis has been applied on the second case study, Aerosol Service Italiana S.r.l., to
define a ranking of environmental, from the first risky to the less one, of the
pharmaceutical sector. The risk analysed is the micro-contamination, the major risk in a
pharmaceutical production.
Definition of a value for
maintenance activities, based on the
number of steps that compose them.
Choice of a risk and definition
of its value for each maintenance
activities, according to its occurrence
in a step.
Multiplication of the value
obtained, to define a value for each
maintenance activity in regards to the risk
chosen.
Definition of a ranking of riskiness
maintenance activities, in regards to the
risk.
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The utility of this application is to focus the attention on the most critic area of the
cleanroom and, if possible, to take preventive measure to reduce or avoid the probability
of occurrence and the impact of possible risks.
The first step consists in define how many maintenance steps are performed in an
environmental unit. Considering each step with a value of 1, it is possible define a value
for each environmental unit.
Environmental units Number of steps performed in E.U.
E.U.1 Cleanroom 23
E.U.2 Clothing change area 37
E.U.3 Material transfer area 56
E.U.4 Storage room 19
Table 9.5: Number of steps performed in each environmental unit.
Second step of the analysis consists in evaluate risks present in each environmental unit.
This means that, given a value of 1 to a risk, it is possible to obtain a value of risk for
each environmental unit, calculating how any time this risk occur in a step. The risk value
is obtained analysing steps performed in each environmental unit.
This means that, if a risk with a value of 1, occur in 5 steps of an environmental unit, the
risk value of this area will be equal to 5.
This application can be done taking into account each risk identified in the framework.
This analysis has been focused on the Micro-contamination risks.
Environmental units Risk value
E.U.1 Cleanroom 21
E.U.2 Clothing change area 37
E.U.3 Material transfer area 43
E.U.4 Storage room 19
Table 9.6: Micro-contamination risk value for each environmental unit.
Next step consists in the match of the two table, to obtain a ranking of environmental unit
according to their riskiness. To obtain these data it is necessary to multiply the number of
steps performed in each environmental unit with the micro-contamination risk of each
area.
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240
Environmental units Number of step Risk value Final value
E.U.1 Cleanroom 21 21 441
E.U.2 Clothing change area 37 37 1369
E.U.3 Material transfer area 43 43 1849
E.U.4 Storage room 19 19 361
Table 9.7: Environmental unit value according to micro-contamination risk.
Values obtained allows to establish a ranking, in order to prioritize environmental units
according to their riskiness.
Ranking Environmental unit
1° E.U.3
2° E.U.2
3° E.U.1
4° E.U.4
Table 9.8: Final environmental unit ranking.
This final ranking highlights that the riskiest environmental unit for micro-contamination
is the E.U.3 “Material transfer area”.
Data obtained allows to take better organisational decisions about maintenance,
improving the management and the quality of it. The identification of riskiest cleanroom
areas, allows to control the diffusion of the risks in all environmental units, minimizing
the risk.
This analysis is made as example, in order to illustrate the concrete application of the
framework. Indeed, values of risks and steps are assumed to be equal to 1, in order to
simplify the explanation.
A more deepened analysis allows to give a significant value to each data, attributing to
theme a weight. Indeed, the value of steps and risks can vary according to several factors
and cannot be assumed all equal to 1. Weights should be evaluated by organisation, based
on its priorities and decisions.
The following map allows to resume and understand the construction and the passages of
this analysis.
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241
Figure 9.2: Schema of the analysis.
Definition of a value for
environmental units, based on the
number of steps that compose them.
Choice of a risk and definition
of its value for each maintenance
activities, according to its occurrence
in a step.
Multiplication of the value
obtained, to define a value for each
environmental unit in regards to the risk
chosen.
Definition of a ranking of riskiness
environmental unit, in regards to the risk.
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9.4 General outcomes of the framework application
The framework proposed allows to obtain several outcomes, useful for the management
of cleanroom maintenance. These outcomes, as described in the previous paragraphs,
permit to find different information about maintenance and their risks, in order to acquire
more awareness about important organizational aspects.
The results obtained in the analysis illustrate that the applicability of the framework to
real sectors produce tangible and numerical data, which can be elaborated and
implemented in different ways.
As explained before, the examples are made assuming a value equal to 1 for each data.
Steps, activities, and risks are not all the same weight. They differ for typology and for
priorities established by the organisation. The allocation of a specific weight to each
parameter of the framework allows to obtain more precise and significant data which can
reflect in the best proper way the reality of the organisation.
Achievable outcomes can be specific of a sector or general. Indeed, analysis made before,
are applicable for both cases studies, changing some variables, as the typology of risk.
The variation of some data depends on the organisation and of the objective that it wants
to achieve.
In the first case, the aim was to obtain a ranking about the activities more subjected to the
macro-contamination risks. This hazard is proper to mechanical engineering sector, in
which the requirements for the correct workability of the product are defined by the
environmental characteristics of the cleanroom (relative humidity, temperature and
pressure) and by the minimization of contamination derived by macro particles.
The second case focuses the attention on the micro-contamination risk, analysing and
obtaining a ranking of riskiest environmental units. This outcome aim to analyse the
riskiest aspect of pharmaceutical sector, in order to obtain a tool useful for the
minimization of the micro particles and microorganisms generation.
The two analysis can be switched between the two case studies, but to have concrete and
reasonable results its necessary to change the typology of risk. Indeed, an analysis of
micro-contamination on the mechanical engineering sector will not have useful results.
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243
However, maintaining the macro-contamination risk as key factor of the analysis, could
be useful to understand which environmental unit can be more subjected to this hazard.
The functionality of the framework and, on consequence, of the outcomes resides in the
way in which information are chosen and elaborated, according to the results that the
organisation wants to achieve, in order to focus the attention on its problems and obtain
data useful for a real improvement of cleanroom maintenance.
Although the specificity that the application of the framework requires, it is possible to
have some general outcomes and information, useful for a correct management of
maintenance and applicable to all sectors:
- Information for the composition of tenders for the supply of facility services;
- Information for the definition of the necessary technical expertise for the correct
execution of maintenance;
- Information about riskiest maintenance tasks;
- Information about riskiest maintenance activities;
- Information about riskiest maintenance steps;
- Information about riskiest environmental unit;
- Information about most important hazards;
- Information about necessary solution to adopt to minimize risks;
- Information about necessary equipment for the correct execution of maintenance;
- Information about the necessary training course for the correct execution of
maintenance;
- Information about the possible diffusion of a risk in all environmental unit and its
prevention;
- Information about the probability and the impact of risks to define a Risk
Assessment.
This list represents some of the possible outcomes obtainable through the elaboration of
the framework. The specificity of each outcome for each organisation emerges from the
requirements of the sector and of the product worked.
The following map allows to understand the application of the framework and the
adaptability of the outcomes:
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244
Figure 9.3: Application of the framework and adaptability of the outcomes.
Tasks and activities Steps, risks and possible solutions
Possible outcomes:
- Information about
riskiest maintenance
tasks;
- Information about
riskiest maintenance
activities;
- Information about
riskiest maintenance
steps;
- Information about
riskiest
environmental unit;
- …..
Mechanical
engineering sector
Pharmaceutical
sector
Food sector
….
245
Conclusions
The thesis has developed an analysis about cleanroom maintenance requirements and
criticalities, in order to understand the complexity of this controlled environment and to
better manage its maintenance.
Starting from an analysis about the meaning of cleanroom, it has been studied all
characteristics of this controlled area, from its structural features, until the description of
different cleanroom typologies.
The study is continued with an examination of all standards that regulate this topic. It has
been analysed the UNI ISO classification method and its variation during the years and
sector by sector.
Then, due to the particularity of cleanroom, it has been chosen to understand and analyse
the concept of risk, giving a general overview about all possible hazards, which can occur
in these areas. After that, the thesis has been continued with the analysis of two case
studies: a cleanroom belonging to a mechanical engineering firm, and a different one,
belonging to a pharmaceutical organisation.
The last theoretical part of the work has been structured with an analysis about general
maintenance requirements and criticalities, in order to give some basic information about
them.
Finally, it has been chosen to elaborate all information studied, providing a framework,
which aim is to analyse and understand maintenance risks and their possible solutions.
This framework has been developed for both case studies, to highlight the versatility of
this tool. Indeed, this analysis helps to enter in details with maintenance activities,
examining every single step of them and identifying possible risks and solutions.
Last part of the thesis has focused on an exemplifying application of this framework. It
has been chosen to carry out two different analysis of maintenance, easily realized thank
to the use of the framework. Indeed, it has been decided to execute these analyses on the
two case studies presented. For the mechanical engineering industry, it has been analysed
the riskiest activity, in regards to the macro-contamination hazard. For the pharmaceutical
246
organisation, it has been chosen to take into account the environmental units that compose
it, identifying the riskiest one, in regards to the micro-contamination danger.
Results obtained has forthwith demonstrated the applicability and functionality of the
framework. Indeed, through a simplified application of this maintenance tool, it has been
possible to obtain significant data, useful for maintenance improvements. These outcomes
have produced rankings of maintenance activities and environmental units, which
illustrate the riskiest activities or unit according to the different typology of hazards
analysed.
These concrete applications allow to obtain substantial data, which can be used during
the definition of cleanroom maintenance and the writing of the Maintenance Plan. The
analysis studied in the thesis is simplified, to make of comfortable and understandable
reading it. In order to obtain more significant and realistic results, each organisation has
to define priorities, weights and requirements of their cleanroom. This allows to perform
more correctly the analysis, considering the necessities of the firm and of the product.
The development of maintenance framework and the choice of which analysis carry out,
vary from organisation to organisation. Exists several applicability of this tool and its
versatility allows to use this framework in different contests, for different sectors.
Indeed, as studied during the thesis, cleanrooms are not standard environments. Their
characteristics vary according to the needs of the product and its process. Starting from
the design, until the definition of the right maintenance to perform, cleanrooms are unique
environments, which have to be considered individually. Their characteristics,
requirements and risks differ according to the needs of the product and the working sector.
Due to this complexity, it is difficult to define a general maintenance strategy for this
controlled environment, and, at the same time, it is complex to define general
maintenance requirements to fulfil and criticalities to avoid.
The objective of this work was to find general guidelines to analyse most important
characteristics of cleanrooms, and define the proper maintenance management. The
structure of the framework allows to apply it to different cleanrooms, because of its
specificity. Information necessary to construct the analysis are easily identifiable and
analysable.
247
The point that clarify the intent of the work is the elaboration of these data. The
elaboration and application of the framework provide a real and concrete instrument for
the definition of cleanroom maintenance.
Through several possible analyses, any organisation can make numerous and deepened
studies about its activities and risks, finding concrete results. These outcomes allow to
have a better control on cleanroom maintenance, organising in the most adequate way its
execution.
This better and specific management of cleanroom maintenance helps to define a precise
Maintenance Plan, based on requirements and risks. In this way, the management of the
general working environment can be matched and managed with the one of the
cleanroom, making this “environment in the environment” an integral part of the
organisation.
248
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