David Campbell CBioL MRSB STERIS Corporation › seksjon › nasjonal-kompetansetj… · •Harmonised against EU MDD 93/42/EEC on Medical Devices •Harmonised against 90/385/EEC

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Chemical Indicators used in Sterilizer and Sterilizer Process Standards 21 May 2019 Nasjonal kompetansetjeneste for dekontaminering Sandvika Norway

David Campbell CBioL MRSB STERIS Corporation

Home Office Edinburgh Scotland UK Leicester UK

Today Sandvika Norway

STERIS Corporation

• Revenues of $2.7 Billion • Over 14000 employees • Manufacturing sites in 6 countries • Supplying to over 100 countries



A longstanding, leading global expertise in sterilization Our history dates back to 1894, to the founding of AMSCO, the American Sterilizer Company.

Albert Browne Ltd History

• In the late 1800’s • James Lister, Robert Koch and Louis Pasteur began

understanding the world of microbiology and the effect of Infection on patients

• In 1870 Albert Browne Ltd began

Albert Browne

• Began selling catheters into hospitals in UK

• Family business until 1975 • Biggest Distributor of

Medical and Surgical Products in UK by 1950

• Acquired 1975 and 1985 • Acquired by STERIS in

2004

Sterilization Indicators

• First Chemical Indicator 1930 • Sheffield Hospital – ‘Childbirth fever’ • Cause traced to Incorrect sterilizer operation • Hospital worker’s husband invented ‘Control Tube’ • Albert Browne was offered the product to commercialise.

World’s First Sterilization Indicator

• Browne Control Tubes Sealed glass vial • Red liquid – changed colour from Red to Green when

exposed to a time and temperature combination • Product is still manufactured and distributed today – over

80 years! • Standards…

The EU Parliament approved the final

text of the EU MDR in May 2017

MDR will replace the

MDD

Current annex ZAs

are harmonised against the

MDD

We will need

additional ZAs for MDR

3 year transition from MDD to MDR

Medical Device Regulations and Standards

Revision to EU Legislation for Medical Devices (EU MDR) • There are currently 3 Medical Device Directives in EU

• 93/42/EEC+2007/47/EC – General MDD • 90/385/EEC - Active Implantable MDD (AIMDD) • 98/79/EC - In Vitro Diagnostic MDD (IVDMDD)

• The EU MDD Directives have been extensively redrafted as the EU Medical Device Regulations

• Regulation (EU) 2017/745 concerning Medical Devices and Active Implantable Medical Devices • Regulation (EU) 2017/746 concerns In Vitro Diagnostic Devices

• The EU Parliament approved the final text of the EU Device Regulations on 25th May 2017

• 3 or 5 year transition – • 2017/745 (MDR) combines the MDD with the AIMDD - has to be fully implemented (date of application) by 26th

May 2020 • 2017/746 (IVDR) replaces the IVDMD - has to be fully implemented (date of application) by 26th May 2022

EU MDR • Very significant changes in EU law • New regulation is 4 times longer • Scope of MDR is greater and includes new devices

• Chemical Indicators are now within the scope of the EU MDR • Existing devices will need to conform to new regulation • Essential Requirements (ERs) now known as General Safety and Performance

Requirements (GSPRs) • Significant changes to requirements considering clinical data, post-market

surveillance, technical documentation and labelling • New requirements for Unique Device Identification (UDI)

• Via EUDAMED database • Increased Notified Body oversight of CE-process • Implementing & Delegated Acts necessary for complete implementation of the

MDRs are not yet in place…

Harmonised EN Standards

Term ‘harmonised’ means harmonised to a

European Directive

Not all EN standards are ‘harmonised’

Standard title is published in Official Journal of EU (OJEU)

Table (Annex ZA) cross- references clauses of the

standard with clauses of the Essential Requirements of the

directive

Harmonised

EN Standards have to be implemented into every

EU member state (currently 28 countries)

Further implementation into European Free Trade

Area (EFTA)

They must be implemented unaltered, so no national deviations

are permitted

Any conflicting national standard has to be

withdrawn

EN Standards

https://www.cen.eu/cen/

Amendment & Systematic review

• Standards can be amended at any time

• Amendment or corrigendum

• Systematic review at least every 5 years

2019 2020 2021 2022 2023 2024

Reaffirm

Revise

Withdraw

Equipment & Process Standards

STANDARDS FOR DECONTAMINATION

Equipment standard

Process standard

Supporting standards

High Temperature Sterilization Standards

STEAM

Equipment standard EN 285

Process standard EN ISO 17665


Low Temperature Sterilization Standards

VHP


Draft

Process standard

EN ISO 14937 Or

ISO 22441D

FORM



EO



High Temperature Equipment Standards

• EN 13060 Sterilization. Steam sterilizers. Small Sterilizers

EN 13060

• EN 285 Sterilization. Steam sterilizers. Large Sterilizers

EN 285

EN 13060 Small Steam sterilizers EN 13060 first published in 2004

Latest version published in November 2014

•Revised to align with machinery directive in Europe

Small sterilizers differ from large porous load sterilizers (EN 285) in:

•size (less than 54 litres) •Performance • low steam supply capacity •small vacuum pumps

Minor amendment underway to correct text confusion regarding allowance of 134 °C – 138 °C with older sterilizers versus 134 °C- 137 ° C with 2014 version

EN 285 Large Steam Sterilizers

EN 285 first published in 1996; major revision in 2006

Two amendments to 2006 version published in 2008 (A1) and 2009 (A2)

EN 285:2015 is latest version

Revision/amendment needed to resolve technical comments deferred from main revision

Revision/amendment underway to address pressure gauge requirements

High Temperature Process Standard

•Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

EN ISO

17665

EN ISO 17665

EN ISO 17665-1 replaced EN 554, ISO 11134 and ISO 13683 in 2006

Specifies methods for validation and routine control for moist heat (steam) sterilization

Revision underway to incorporate guidance (currently in part 2) and product families (currently in part 3) into a single standard

Significant changes to EN ISO 17665 are likely to occur

Low Temperature Equipment Standards

• Sterilizers for medical purposes — Ethylene oxide sterilizers - Requirements and test methods

EN 1422

• Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing

EN 14180

• Sterilizers for medical purposes — Low temperature vaporized hydrogen peroxide sterilizers — Requirements and testing

prEN 17180

EN 1422:2014 is latest version; superseded EN 1422:1997+A1:2009

Harmonised EU standard (harmonised against EU MDD 93/42/EEC)

Major revision in 2014: • Scope changes • Explicit exclusion of sterilizers which employ the injection of EO or mixtures

containing EO directly into packages or into a flexible chamber • Removal of types A and B of EO sterilizers • A - user programmable (industrial) • B - typically smaller and have fixed cycles (health care)

• Alignment with structure of LTSF standard EN 14180 • Annex D deleted (sound power test)

EN 1422 EO Sterilizers

EN 14180:2014 is latest version; superseded EN 14180:2003+A2:2009

Harmonised EU standard (harmonised against EU MDD 93/42/EEC)

Major revision in 2014:

• The terms risk assessment, risk analysis and software validation added • Biological testing aligned with method from ISO 25454 • Machinery safety requirements, mainly as a consequence of compliance

with the machinery directive added • Requirements and testing for sound power and vibration updated

EN 14180 Formaldehyde Sterilizers

prEN 17180 Vaporized hydrogen peroxide sterilizers

Work item to develop a sterilizer standard for vaporized hydrogen peroxide sterilizers; approved in September 2015

Work began at a meeting in Brussels in February 2016

Uses vaporized hydrogen peroxide [VH2O2] as the sterilant

Standard defines the design & performance of the sterilizer, rather than the process

Work likely to take at least another year (PWI 3 years max)

Low Temperature Process Standards

•Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

EN ISO 25424

• Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

EN ISO 11135

• Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

EN ISO 14937

EN ISO 11135 EO Process EN ISO 11135:2014 is latest version; superseded ISO 11135-1:2007 and ISO/TS 11135-2:2008

Harmonised EU standard

• Harmonised against EU MDD 93/42/EEC on Medical Devices • Harmonised against 90/385/EEC on Active Implantable Medical Devices

Updated in 2014:

• It replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008 • Part 1 was requirements and part 2 was guidance on the application of part 1 • Both technically revised and condensed into a single standard • Guidance placed in annex D

EN ISO 14937:2009 is latest version

Currently used for ‘novel sterilization processes, e.g. hydrogen peroxide sterilization processes

Harmonised EU standard

• Harmonised against EU MDD 93/42/EEC on Medical Devices • Harmonised against 90/385/EEC on Active Implantable Medical

Devices

EN ISO 14937 Generic Process

ISO/CD 22421 Common Aspects of Sterilizers ISO has just started developing a new standard on common aspects of sterilizers; work is likely to take 3 years

Its application would potentially include all types of sterilizers for health care applications

It would enable common requirements across a range of equipment

Scope consists of:

• Material, design and construction • Chamber requirements • Doors and interlocks • Noise, heat, vapour, vibration and EMC emissions • Quality & risk management • Safety requirements • Service and local environment • Information to be provided by the manufacturer • Test Equipment etc

Information being considered from EN, US, Japanese and Australian sterilizer standards, as well as IEC 61010-1 and IEC 61010-2-040


STEAM




Process and Equipment Standards

Equipment standards specify the requirements for the physical equipment i.e. the sterilizer • Equipment standards are manufacturer standards

Process standards specify the requirements for the cycles that are conducted in that equipment • Process standards are user standards

Why split like this?

Equipment vs. Process Standards

Some aspects of an equipment standard are the responsibility of the user • Or at least the user’s facility • For example, services

The manufacturer of the equipment does not always know

how it will be used

We recognise that there is an overlap, or grey area…

Overlaps between Equipment and Process

Process • Designed by the equipment

manufacturer • May be modified by User

• Cycle i.e. process, cannot be established without an understanding of the equipment

Equipment

• Is used according to the demands of the user

• Requirements for the cycle cannot be divorced from the equipment

High Temperature Equipment Standards

• EN 13060 Sterilization. Steam sterilizers. Small Sterilizers

EN 13060

• EN 285 Sterilization. Steam sterilizers. Large Sterilizers

EN 285

EN 285:2015

102 pages…

Scope: •Must be able to accommodate a sterilization module (STU) or have a chamber volume of at least 60 litres

Specifies requirements and tests for large steam sterilizers for the sterilization of medical devices •primarily used in health care

Defines a sterilization module

Defines test loads designed to represent the majority of loads • i.e. wrapped goods consisting of metal, rubber and porous materials •Specific loads (e.g. heavy metal objects or long and/or narrow lumen) require the use of other test loads

Large steam sterilizers can also be used in industry during the commercial production of medical devices

Machinery Directive

When EN 285 was first published (1996), sterilizers (and washer-disinfectors) were considered accessories to a medical device (but were not considered ‘machines’) • This requires CE marking (as an accessory) to the MDD

The 2007/47/EC modification to 93/42/EEC aligned sterilizers (and washer-disinfectors) to the machinery directive 2006/42/EC • Sterilizers (and washer-disinfectors) are now considered ‘machines’ and must be CE marked against the

MDD and Machinery Directive

There are 2 annex ZAs against the MDD and the MD in the 2015 version of EN 285

EN 285 Normative References • EN 764-7:2002, Pressure equipment - Part 7: Safety systems for unfired pressure equipment

• EN 867-5:2001, Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

• EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices

• EN 13445-1:2014, Unfired pressure vessels - Part 1: General

• EN 13445-2:2014, Unfired pressure vessels - Part 2: Materials

• EN 13445-3:20143), Unfired pressure vessels - Part 3: Design

• EN 13445-4:2014, Unfired pressure vessels - Part 4: Fabrication

• EN 13445-5:2014, Unfired pressure vessels - Part 5: Inspection and testing

• EN 13445-8:2014, Unfired pressure vessels - Part 8: Additional requirements for pressure vessels of aluminium and aluminium alloys

• EN 14222:2003, Stainless steel shell boilers

• EN 22768-1:1993, General tolerances - Part 1: Tolerances for linear and angular dimensions without individual tolerance indications (ISO 2768-1:1989)

• EN 60204-1:2006, Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC 60204-1:2005, modified)

• EN 60584-1:2013, Thermocouples - Part 1: EMF specifications and tolerances (IEC 60584-1:2013)

• EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC 60751:2008)

• EN 60770-1:2011, Transmitters for use in industrial-process control systems - Part 1: Methods for performance evaluation (IEC 60770-1:2011)

• EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (IEC 61010-1:2010)

• EN 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC 61010-2-040:2005)

• EN 61326-1:2013, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements (IEC 61326-1:2012)

• EN ISO 228-1:2003, Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000)

• EN ISO 3746:2010, Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)

• EN ISO 11140-3:2009, Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

• EN ISO 12100:2010, Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010)

• EN ISO 13408-2:2011, Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

• How many normative references are there in EN 285:2015? i.e. How many additional standards are necessary to comply to EN 285? 23!

Leak Rate Test 7.1.14, 18

An automatic leak rate test must be included

• Vacuum level of less than 70 mbar, then vacuum pump stopped and all valves closed

• Dwell of 5 minutes, followed by test period of 10 minutes

Leak rate shall not exceed 1.3 mbar per minute over 10 mins

Air Detector 8.2.4

• Option in EN 285 • If an air detector is not fitted, means need to be provided

to verify steam penetration in each cycle • If no air detector a means of verifying steam penetration

should be used. • In practice some countries who have air detectors also use

batch control PCD to release or not release the load.

Services 13.3.4, Table 4

• Services are not necessarily in control of the sterilizer manufacturer

• Steam, water, compressed air, electricity, drainage etc • ‘The sterilizer shall be designed to operate with…’

Please enure your Chemical Indicators do not add to this !

Type Testing and Recommended Test Programme, Table 5


STEAM




High Temperature Process Standard

•Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

EN ISO

17665

EN ISO 17665

EN ISO 17665-1 replaced EN 554, ISO 11134 and ISO 13683 in 2006

Specifies methods for validation and routine control for moist heat (steam) sterilization

Revision underway to incorporate guidance (currently in part 2) and product families (currently in part 3) into a single standard

Significant changes to EN ISO 17665 are likely to occur

Sterilization Agent - 5

• Sterilizing agent is moist heat • We do not use the term ‘STEAM’ without clarification • ‘Fluids’ sterilization is also considered moist heat…

Process & Equipment Characterization 6

• Considers: • Description of the operating CYCLE • Process parameters and their tolerances • Product families than can be sterilized • Pre-conditioning of product, if necessary • Load configuration • Location and acceptance criteria for BIs and CIs • Minimum lethality • etc

Specification - Saturated Steam Processes 6.1.2

• Typically used in health care (hospitals) • Considers:

• Hold time • Theoretical steam temperature max delta T • Steam penetration test(s); air leakage rate • Specified reference load • Monitoring device(s) • Dryness

Specification – Contained Product Processes 6.1.3

• ‘Fluids’ processes

Specification – Equipment 6.2

• Description • Location • Services • Conformity documentation

Product Definition - 7

• Product to be sterilized must be specified • Includes packaging • Product family assignment • Process Challenge Device (PCD) definition • Limiting values for process variables • Pre-requisites

• E.g. cleaning, disinfection • Bioburden

Process Definition - 8

• Definition of the sterilization process • Minimum Sterility Assurance Level (SAL)* • Maximum level of air or other non-condensable gases

(NCGs) • BIs (conform to EN ISO 11138) • CIs (conform to EN ISO 11140)

Process Definition – SAL – 8.11

• 3 methods • Bioburden method (annexes B & C) • Overkill method (annex D) • Pharmacopoeial method

Validation - 9

• Everything must be validated! • Calibration • IQ, OQ and PQ

IQ, OQ, PQ - 9

• Installation Qualification (IQ) • Equipment and documentation are as intended/specified • Installed correctly • Services are correct • Safety devices function • No leaks or obvious defects

• Operational Qualification (OQ) • Demonstrate that installed equipment will deliver the specified sterilization

process • Test loads used so show performance

• Performance Qualification (PQ) • Performance testing on actual products to be processed

Routine Monitoring - 10

• Routine monitoring and control must be carried out on each operating cycle

• Monitoring considers: • Air leakage • Steam quality and NCGs • Automatic control • Steam penetration • Delivery of sterilization process

• Uses CIs, BIs and PCDs • Physical parameter information

Product Release - 11

• Must be a formally defined procedure that includes: • Review of records • Mechanism of release • Segregation of conforming and non-conforming materials/loads

What is the Problem?

Control of a Steam Sterilizer • Many steam sterilizers use

knowledge of the properties of steam to control and monitor the process

• PRESSURE of steam is controlled • TEMPERATURE of load is

monitored • There is no means (or need) to

control presence of moisture • MUST control air or

NCGs 0

0,5

1

1,5

2

2,5

100 121 134

Pres

sure

(Bar

)

Temperature (C)

Control this

Monitor this

Removal of Air • Is air lighter or heavier than steam?

• Heavier! WHY REMOVE AIR? • Remaining air in or on a load will be concentrated within the load • Insulate the load and prevent attainment of the necessary

temperature • The temperature difference of 2 °C in EN ISO 17665-1 is a consequence of

this • Insufficient moisture to kill micro-organisms HOW? • Air is removed by using a series of steam and vacuum pulses

• Steam pulses not used to heat load, as steam can do this extremely quickly, as long as steam can contact all parts of the load i.e. all air has been removed

• High thermal-inertia loads will also heat up quickly - as long as air is adequately removed (we shouldn’t need extended hold time cycles…)

Control of Air • Air and other non-condensable gases (NCGs) need to be

reduced to a level as low as possible • This is done by:

• Minimising amount of NCGs in steam • Minimising air leaks into chamber

• How is this checked? • Periodic (daily?) leak rate test • Bowie Dick test at commencement of each day • In-cycle means to measure steam penetration/air removal

• Internal chemical indicators in each load item, plus: • In UK, Ireland & Australia: air detector fitted to the sterilizer • Other parts of the world: charge control or challenge pack

Air Detectors

• BS 3970:1966 was amended in August 1969 to include a requirement for an ‘air detector’ to monitor every cycle

• ‘A device capable of detecting the presence of air in sufficient quantity to prevent…sterilizing conditions …shall be fitted to form part of the automatic control’

• There are 3 ways in which air detectors can operate: • ‘Thermometric’ air detectors • ‘Partial Pressure’ air detectors • ‘Condensate’ air detectors

Thermometric Air Detector

Temperature Probe

Air detector tube Drain

Sterilizer chamber

Air

Steam

Partial Pressure Air Detector

Drain

Sterilizer chamber

X

Pressure transducer

Cooling water

Isolating valve

‘Condensate’ Air Detector

Drain

Sterilizer chamber

Detector

Condenser

Capillary

Sensitivity of Air Detectors

• The 3 types of air detector vary in sensitivity • Performance is dependant upon how they are calibrated • Influenced significantly by:

• Air leak position • Load size & type • Chamber size

• Air detectors are not perfect, however: • Air detectors do monitor every cycle, although not as

accurately as a Bowie Dick test

Control of Air in a Steam Sterilizer

• Two approaches are used to assess the steam penetration and therefore air & other non-condensable gases in the sterilizer chamber

•Porous Load Approach

•Hollow Load Approach

What are Porous Loads?

• Wrapped and steam-permeable loads • Porous loads incorporating significant mass demonstrate a

significant challenge to a steam sterilizer • Steam will be attracted to the mass of a porous pack and

will penetrate into it • Porous loads may not challenge depth of vacuum used for

air removal • Hollow loads present a greater challenge to depth of vacuum

Porous Loads & Steam

Steam & air mixture

Bowie Dick Test, Yesterday & Today

• The original towel pack was described by Bowie and Dick in 1963:

• Bowie, J.H., Kelsey, J.C. and Thompson, G.R., Lancet, i, (1963), p. 586

• The origins of this test form a key part of OQ of steam sterilizers:

• NF EN 285:2015, Sterilization — Steam sterilizers — Large sterilizers, Small load thermometric test, clause 16.1

• Current performance requirements for the Bowie Dick test are given in EN ISO 11140-4

Origins of the Hollow Device

• Hollow lumen testing originated as a test to demonstrate penetration of the sterilizing agent in Low Temperature Steam and Formaldehyde (LTSF) sterilizers

• Commonly known as the Line–Pickerill Helix • Line, S.J., Pickerill, J.K., J. Clin. Pathol., 1973, 26pp, 716-720

• Further developed for use in EO sterilization • More recently used for penetration of steam in moist heat

sterilization • EN 867-5; draft ISO 11140-6 (both defined for small steam

sterilizer testing)

Line-Pickerill vs. EN 867-5

Line-Pickerill • Capsule volume 0.75 cm3

• internal diameter 3mm • wall thickness n/a • length 4650mm • capsule ratio 6% of tube volume

EN 867-5 • Capsule volume 0.28 cm3 • internal diameter 2mm +/- 5% • wall thickness 0.5mm +/- 0.5% • length 1500mm +/- 1% • capsule ratio 6% of tube volume

What are Hollow Loads?

• Loads consisting of lumens or channels • Steam will be attracted to the mass of a lumen PCD

capsule, and not to the open end of the lumen • Air leaks are therefore more difficult to detect

• PCDs incorporating lumens associated with mass are much more sensitive to detection of air leaks

Steam Penetration • Lumens can be difficult to penetrate • Ease of penetration will be based on

• Diameter of lumen • Open ended or closed

• If closed, the volume of the terminal end (capsule) versus the total lumen volume

• Mass of material • Conductivity of material • Specific heat capacity of material

• Penetration with a condensing gas is complex • Different mechanism to penetration into porous loads

Hollow Device PCD

• Steam penetration into a lumen device will be affected by the vacuum level reached

• Hollow PCDs based on lumens are good at detecting poor vacuum levels

• Sterilizers are better at determining vacuum levels! • Hollow PCDs are not good at detecting small air leaks • CAUTION:

• PCDs are not designed to simulate real medical devices; successful penetration into a PCD does not guarantee penetration into an actual medical device

Bowie Dick Cycle Hollow and Porous Load Cycle Steam Penetration/Air Removal Coverage in %.

0 100% Porous 90% Covered----------------------------------------------------------- ! Hollow 10%

Hollow plus Porous Mass • Specifically designed to confirm

steam penetration into both porous and hollow devices

• Benefits of both porous and hollow approach to steam penetration monitoring

Porous vs. Hollow

Porous • 55 year history • Large mass • Capable of detecting small

air leaks • Used as small load

thermometric test in EN 285

Hollow • 45 year history • Small mass • Incapable of detecting

small leaks • Sensitive to ultimate

vacuum depth

Principle of the Steam Penetration Test • Test MUST be conducted in an otherwise empty chamber • Other load items will cause preferential mass flow of steam

to condensation sites • In this case, test sensitivity will be reduced

Don’t Forget Pack Monitoring!

• Use of internal indicators ensures monitoring of steam penetration in actual loads

Sterilization Monitoring • Sterilizer should be tested at the start of every day

• Bowie Dick Test • Each cycle must be tested

• Air detector or process challenge device • Each load must be monitored

• Internal chemical indicators • There is not a single perfect solution to process monitoring • Choice available for hollow and porous devices • A combination of both hollow and porous devices, in an

EN ISO 11140-4 device, is the best of both worlds


Thank You

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Documents

David Campbell CBioL MRSB STERIS Corporation › seksjon › nasjonal-kompetansetj… · •Harmonised against EU MDD 93/42/EEC on Medical Devices •Harmonised against 90/385/EEC