1. A presentation on New Trends in Modular cleanrooms
2. Flow of Presentation History of Clean Rooms Introduction to
Clean Rooms Emerging Trends in Cleanrooms Need of Clean Rooms
History of Clean Rooms in Healthcare
3. A cleanroom is an environment, typically used in
manufacturing or scientific research, that has a low level of
environmental pollutants such as dust, airborne microbes, aerosol
particles and chemical vapors. More accurately, a cleanroom has a
controlled level of contamination that is specified by the number
of particles per cubic meter at a specified particle size. To give
perspective, the ambient air outside in a typical urban environment
contains 35,000,000 particles per cubic meter in the size range 0.5
m and larger in diameter, corresponding to an ISO 9 cleanroom,
while an ISO 1 cleanroom allows no particles in that size range and
only 12 particles per cubic meter of 0.3 m and smaller (see table
below).
4. Class maximum particles/m FED STD 209E equivalent0.1 m 0.2 m
0.3 m 0.5 m 1 m 5 m ISO 1 10 2 ISO 2 100 24 10 4 ISO 3 1,000 237
102 35 8 Class 1 ISO 4 10,000 2,370 1,020 352 83 Class 10 ISO 5
100,000 23,700 10,200 3,520 832 29 Class 100 ISO 6 1,000,000
237,000 102,000 35,200 8,320 293 Class 1000 ISO 7 352,000 83,200
2,930 Class 10,000 ISO 8 3,520,000 832,000 29,300 Class 100,000 ISO
9 35,200,000 8,320,000 293,000 Room air
5. History of Cleanrooms The Clean-room is a recent technology
coming to the age as part of the Atomic Age and greatly enhanced in
the space-age. However, its roots go back hundreds of years to
swiss watch makers who used to cover their precious watches with a
small bell jars when they were not working on them to prevent dust
from falling on them. The American Civil war (18611865) gave
impetus to the next phase, when due to immense loss of life due to
bullet wounds surgeons recognised the need for steps to prevent
post traumatic infections. So, the methods were developed to
achieve this and sterility became a watchword in operating suits
and surgical tools. As a final step the development of HEPA (High
efficiency Particulate Air) filter at Sandia Labs for Atomic Energy
Commission after World War-II, in 1945 where deadly nuclear
particles were isolated in process areas with HEPA filters while
allowing air to circulate in them.
6. History of Clean-rooms in Healthcare sector The first
Clean-rooms in Healthcare were found in hospitals It was after
Pasteur, Koch, Lister and other pioneer microbiologists and
surgeons over a 100 years ago established that bacteria cause wound
infections It was discovered that elimination of bacteria from
hospital and in particular Operating room should prevent infection
This was the scientific basis for the first clean rooms Joseph
Lister (1827 1912) British surgeon Heinrich Hermann Robert Koch
(1843-1910) Prussian physician Lister's Operation Theatre
(1869)
7. Why are Clean Rooms needed? Need To reduce contamination
levels in the product or services performed To achieve compliance
to world wide standards like cGMP, USFDA etc. the manufacturing has
to follow certain standards (ISO standards) which makes clean-room
a compulsion than a need. These standards cant be achieved without
following contamination control technology, of which clean rooms
are an important part. Contamination Control Technology : It deals
with the removal of particles from the air and the levels of air
cleanliness that can be achieved How items are handled, cleaned and
stored What equipment is used and the method of its use. What
materials are used in the process and what changes take place to
that material, what are the contaminants, where do they come from
and how can they be eliminated
8. Sources of Contamination 1. Facilities (building) Walls,
floors and ceilingsPaint and coatingsConstruction material Air
conditioning debrisRoom air and vaporsSpills and leaks 2. People
Skin flakes and oilCosmetics and perfumeSpittle Clothing debris
(lint, fibers etc.)Hair 3. Tool Generated Friction and wear
particlesLubricants and emissionsVibrations Brooms, mops and
dusters 4. Fluids Particulates floating in airBacteria, organics
and moisture Floor finishes or coatingsCleaning chemicals
Plasticizers (outgasses)Deionized water 5. Product generated
Silicon chipsQuartz flakesCleanroom debris
9. Key Elements of Contamination Control Cleanroom
Construction: Cleanrooms construction material should be
non-shredding, Chemically stable/ resistant, with minimal places
for dust-settlement. HEPA(High Efficiency Particulate Air Filter)
They filter particles as smallas 0.3 microns with a 99.97% minimum
particle-collective efficiency. Cleanroom Architecture: Cleanrooms
are designed to achieve and maintain a airflow in which essentially
the entire body of air within a confined area moves with uniform
velocity along parellel flow lines (laminar flow). As, turbulence
can cause particle movement. Filteration: In addition to the HEPA
filters commonly used in cleanrooms, there are a number of other
filtration mechanisms used to remove particles from gases and
liquids. These filters are essential for providing effective
contamination control. Cleaning: Cleaning is an essential element
of contamination control.
10. Key Elements of Contamination Control Laminar Air-Flow
Turbulent Air-Flow
11. Pharma Industry Dynamics Pharma Industry Development
12. Disadvantages of Brick-walls It shreds particles and Gets
chemically effected very fast Paint peals off very fast leading to
high maintenance cost (frequent painting) Absorbs moisture
expediting the paint peal-off and particle shreding. No modularity.
In case of any change required the area will need to be shut down
for weeks together. Re-validation will be required after any
changes. More down time due to maintenance reasons.
13. Emerging trends in Cleanrooms
14. Types of Cleanroom Construction Trends in clean room
partition materials 1900 s 1980 s 2000 s 2006 Plaster / Blockwork
Plasterboard /Studwork /paint Solid core panel monoblock+factory
applied paint finish Hollow core/ 2 part panel /factory applied
finish GI & HPL Pre- Engineered Panels GRP Panels
15. It is a general partitioning system, which is being used in
pharmaceutical cleanrooms just because of lower price. These panels
are not Pre-engineered & all cut-outs, conduits, view-panels
are done manually at site. This drastically reduces the final
finish quality. Thickness of 50mm is not very sturdy and doesnt
allow many utilities and switch-boards to fit into it. The paint is
wet type and paint thickness is just 20-25 microns. So, the scratch
resistance is very poor as compared to powder coating. CRC sheets
used in making panels instead of GI. This increases the risk of
rusting at later stage. C-Type floor-track is used to fix the panel
on the floor. This leads to a direct contact between the panel and
any kind of seepage/ spillage/ leakage of water etc. Resulting in
bacteria formation. Removal of partition is very difficult after
installation. Hanging system is used for ceiling (load-bearing
capacity of 70-80 Kg/m2) and very less movement space over ceiling.
Also the ceiling cut-outs are done at site and covered with
channels from outside (not welded), hence reduced strength of
panels with cut-outs. PVC covings and corners in standard colours
is provided Overall final finish is not very good Disadvantages of
thin pre-painted panels
16. Major highlights: Integrated system specially designed for
Pharmaceutical industries. Pre-engineered system (panels, cut-outs,
conduits, view-panels are designed and manufactured in factory) as
per design requirements. Inbuilt risers for low-level air discharge
resulting in better aesthetics and better space utilization. Raised
type floor-track can be provided to accommodate epoxy coving. This
results in total flushing of epoxy coving with walls. Truss system
used for ceiling hanging for sturdy ceiling (load-bearing capacity
of 150 Kg/m2) and more movement space over ceiling. Aluminium
Powder coated covings and corners to match colour, gloss as of
partitions and for better life. Doors and accessories are specially
designed to suit the clean-room requirements. Pre-engineered
Partitioning System
17. Pre- Engineered, Pre-Designed (different sized panels as
per requirement) Progressive / Non-Progressive (Both types) are
provided as per layout requirement. (Please see an Example of Pre-
Engineered panels in next slide) Pre-Engineered Panels Standard
Design Standard Length and Width panels are supplied and are cut at
site to make any changes Pre-engineered 80 mm Partitions Normal
Partitions
18. Pre-Engineered Panels
19. - Panels have a profile all around and channels are welded
to the sheet to give more strength - The wall panels supports the
load- bearing ceiling. i.e. Panels are self- supporting -
Stiffeners are provided where-ever required in ceiling panels and
hence more strength. - Better chemical resistance due to 70- 90
microns of powder coating. Panels Having more strength Panels are
made of sheets pasted on the frame of GI or Aluminium resulting in
lower strength Also some panels doesnt have any supporting profile/
frame 80 mm Partitions Normal Partitions
20. Raised Floor Track Raised type Floor Track C Type Floor
Track 80 mm Partitions Normal Partitions Disadvantages of C-Type
Floor Track: PVC or Al. Coving is only option in this case. Since
panels are resting just on the C Channel; Any seepage of water will
enter the area behind coving and also panels bottom and create
bacterial formation/ Contamination Advantages of Raised Floor
Track: This allows total flushing of Epoxy coving with wall panels
thus giving total flush surface and also avoids Water contact with
the panels, so no chance of any bacterial growth.
21. Truss Hanging ROOF HANGING Rod Hanging Truss Type Hanging
Normal Partition
22. RETURN AIR RISER Inbuilt Risers In 80 mm Panels Advantages
of In-built risers: Smooth surface of wall, as internal ducts acts
as risers. Proper space utilization is possible, as no obstacles
are there in the rooms in terms of external riser ducts. Easy duct
connections at the top. More clear area inside the rooms. Easy
cleaning of rooms is possible as wall surfaces are in straight
lines.
23. RETURN AIR RISER Projected Type Risers Normal Partitions
Disadvantages of Projected risers: Non-Smooth surface of wall, as
the externs ducts creates a many projections in the wall. Proper
space utilization is not possible, as many obstacles/ projections
are there in the rooms in terms of external riser ducts.
Duct-connection at the top of riser is difficult. It decreases
clear area inside the rooms. Cleaning of rooms is difficult due to
presence of projected risers as wall surfaces are in not in
straight lines.
24. 80 mm pre-engineered partitions Normal Partitions Paint
Quality Paint Type: Pure Polyester Method: Powder coating , oven
baked Paint Thickness: 70 to 90 Microns Gloss level: 25 % Maximum
Cross-cut/ Paint Adhesion Test: Done Paint Peal-off test: Done
Impact/ Drop Test : Done Chemical Resistance: Yes ADVANTAGES: -
Better final finish - Low fatigue in working (low gloss) - More
life - Better Scratch and Chemical resistance Paint Type: Wet PU
paint Method: pre-painted sheets used to make partitions Paint
Thickness: 20 to 25 Microns Gloss level: above 35% Paint Adhesion
Test: Not Done Paint Peal-off test: Not Done Drop Test : Not Done
Chemical Resistance: Very low DISADVANTAGES: - Poor final finish -
Higher fatigue due to higher gloss - Lower life - Poor Scratch and
Chemical resistance
25. Chemical Resistance chart of Powder Coating
26. Bend Test Different tests for powder coating Scratch Test
Weight drop Test
27. Different tests for powder coating and bar coding Gloss
level test (205%) Dry film thickness test (70-90 micron) Bar coding
for easy identification
28. Factory Made cut-outs with conduits fitted in factory:
-With and Without Lip cut-outs possible for ceiling - Conduits are
fitted in factory in wall cut-outs - All cut-outs are covered with
channels fitted inside them, which are welded - These results in
proper sealing (i.e. Infill is not in touch with wires/
connections. Hence less fire hazards) - Proper welding of channels
results in higher strength. - Machine made cut-outs give better
finishing. 80 mm Pre-engineered Partitions Wall/ Ceiling Cut-outs
and Conduits
29. Cut-outs are done manually at site - Only Through cut-outs
possible for ceiling - Conduits are fitted at site in wall
cut-outs, which are also done at site - Only ceiling cut-outs are
covered with external covering channels. These are just put on
cut-out in pieces with no welding etc. - No covering channels in
the wall cut-outs results in no sealing (i.e. Infill is in touch
with wires/ connections. Hence more fire hazard) - No welding of
channels results in lower strength. - Man made cut-outs results in
poor finishing. Normal Partitions Wall/ Ceiling Cut-outs and
Conduits
30. Load bearing capacity of 150 kg/m2 Load Bearing Ceiling 80
mm Pre-engineered Partitions Truss system for hanging and self-
supported system (Wall panels supports the ceiling panels and are
rested on it)
31. Load Bearing Ceiling Load bearing capacity of 90-100 kg/m2
Normal Partitions Turn- Buckle system for hanging is used; This
results in poor mobility space over ceiling and lower load bearing
capacity
32. VIEW PANELS Factory fitted View Panels Advantages of
Factory fitted view panels : -View-Panels are fitted in factory in
controlled environment and hence no dust/ moisture etc. Is present.
- Cavity is made on CNC machines resulting in high quality and
finish. - SS channels inside the two glasses gives even better
finish.
33. DOOR FIXING Door Fixing in partitions Advantages of
Pilaster joints in doors: Easy Removal of door is possible by
removing both sides pilasters. This is extremely useful in case any
big machine/ item needs to be transferred to/ from the room. After
removing the door the height and width of open space is increased.
Conduits for Door-interlocking/ Access control etc. Can easily be
accommodated inside the plaster joints on both sides of the door.
Pilaster fixing of doors
34. Aluminium frame cut in parts and fixed at site DOOR FIXING
Normal Partitions Disadvantages of Aluminium frame in doors:
Removal of door is not possible or is very difficult. Even if the
door is removed the door over panel (DOP) cant be removed. So, any
removal/ shifting of bigger machines becomes very difficult.
35. Factory Fitted View-panels Different sheet thickness of
door frame and door leafs is considered for better strength. Press
fit type door seal is used resulting in better finish and low
maintenance. Powder coating on doors and frames for better
appearance (same colour for frame and door leafs) and life. Good
quality of accessories are used (door closure (Dorma), SS ball
bearing hinges, SS handles, Drop seals etc.) DOOR Features
Pre-engineered Partitions Normal Partitions Site Fixed View-panels
Aluminium frame (generally without paint) and same thickness
pre-painted sheet (as of the partitions) is used to make door leafs
resulting in poor strength. Pasted type door seal is used resulting
in poor finish and more maintenance. Pre painted sheet for doors
and bare frames results in poor appearance/ life. Normal
accessories are used instead of specially designed clean-room
accessories, which results in frequent failures and poor
performance.
36. COVING Normal PartitionsPre-engineered Partitions
Advantages of Aluminium Powder Coated covings and corners:
-Aluminium powder coating of covings have very good strength and
life. - Exactly same colour and gloss level as of partitions is
maintained resulting in better look and finish. - If required to
remove and re-fix, it will not break-up as in case of PVC covings.
Disadvantages of PVC covings and corners: - PVC covings have poor
strength and life. - Colour as not possible to match resulting in
poor look and finish. - If required to remove and re-fix, it will
break-up, as it becomes brittle after some time.
37. Pre-engineered Partitions- Final Finish
38. Advantages of HPL Partitions - Panel skin is non-metallic
and hence no static charge. So it is suitable for areas requiring
low static charge. - HPL is having very good scratch resistance due
to melamine coating done on the skin. - The panel skin is having
very good mechanical properties i.e. no denting or breaking due to
impact. - Final finish of the project is excellent and there is no
waviness in panels. - No rusting/ deformation in due course of
time
39. HPL Installation photos
40. Advantages of GRP partitions - Panels are molded out of
resins with reinforcement of fibers. Material is virgin in nature.
- Chemical resistance of GRP is very high. Even can withstand high
potential acids. - One service panel after each solid panel. -
Inbuilt / molded covings. - High capacity return-air risers (150mm
depth) are provided within wall. - Bigger view-panels provided. -
Mechanical strength of product is very high. - Repairable at site
in case of any kind of damage.
41. GRP Installation photos
42. CRUX of the presentation 80mm Pre-engineered partitions
system design is most suitable for pharmaceutical cleanrooms.
However GRP partitions are best suited for more critical facilities
like Oncology, Hormones etc. which needs frequent fumigation by
using harsh chemicals.
