Sterilization Standards

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INTERNATIONAL AND

EUROPEAN PURPOSE OF THE PRESENTATION:


STERILIZATION „ To provide a brief introduction to standards and the
STANDARDS standardization bodies.
To introduce the current sterilization and associated
“All Change Please”
„
standards focusing on:
„ The moist heat processing standards.
Dr Brian Kirk „ The moist heat equipment standards.
„ The Chemical and Biological Indicator Standards for
Senior Technical Service Specialist Moist Heat Sterilization.
„ To provide an update on the revision of the moist
3Health Care Ltd. heat processes and equipment standards.
Oct 06

B. Kirk – Product Development Scientist.


Member of: What are standards:
„ ABHI – Sterilization & Microbiology Committee „ Standards are;
„ BSI - CH198 – Sterilization „ written documents,
„ BSI - LBI/35/3 – Chemical and Biological „ agreed by consensus of all parties involved
Sterilization Indicators. „ approved by a recognised regulating body
„ CEN - TC 102 wg 2/3 – Steam Sterilizers „ a specification for a given device or a process
„ CEN - TC 102 wg 7 - Chemical and Biological designed to achieve a desired end point.
Sterilization Indicators.
„ ISO - TC 198 wg 3 – Moist Heat Sterilization.
„ ISO - TC 198 wg 4 – Biological Indicators.
„ ISO - TC 198 wg 6 – Chemical Indicators.

Standardisation of outcomes
Why do we need them: eg of a sterilization process
„ To ensure that what we want is
SINGLE USE PRODUCTS

what we get (purchasing spec).


•LINEAR MANUFACTURING PROCESSES
•MOSTLY USED IN INDUSTRY
„ To avoid cross border barriers to OUTCOME
trade. THE SAME
„ To enable a universal approach to A STERILE
achieving a given objective MULTI USE PRODUCTS PRODUCT
„ eg a sterile product. •CIRCULAR MANUFACTURING PROCESS
•MOSTLY USED IN HEALTH CARE
SETTING

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The Standards Organisations: The Standards Organisations:
1. National Organisations: 2. Regional Organisations:
UK - BSI
USA -AAMI/ANSI Ge - DIN
Ne - RIVM
Fr - AFNOR
etc
Comité Européen de
Normalisation
European Committee for Standardization

Committees populated by experts from industry, academia, Eg CEN – Committees populated by delegates nominated from
user groups & regulatory bodies. each EU countries standards body.

The Standards Organisations:


3. Global Organisations: Points to Note:
International „ Standards are voluntary BUT compliance to
ISO Organization for standards identifies a clear path to regulatory
Standardization compliance (see Article 5 of MDD).
„ ISO standards can be;
„ adopted as National Standards,
„ coexist with existing National Standards,
„ be subject to local variations (national deviations).
„ CEN standards for EU member states have to be;
„ adopted as national standards,
„ adopted unchanged,
Committees populated by delegates nominated by each countries „ any conflicting local standards must be withdrawn.
standards body (mostly N America, EU, Japan & Australasia)

Medical Device Directive – Article 5 The Vienna Agreement


„ Under MDD, Medical Devices have to be CE „ An agreement made between CEN and ISO to
marked when sold in EU. ensure harmonisation of standards published by
„ This means the Essential Requirements of MDD the two organisations.
must be met. „ When standards are reviewed under the terms of
„ Article 5 states that products complying with a the agreement, one of the organisations take the
harmonised EN are presumed to meet the lead and revise both sets of standards in a single
Essential Requirements of the MDD stated in committee.
annex ZA of the standard. „ Once finished the resulting document will go out for
„ Thus Harmonised EN’s are very important to “parallel voting” which means member bodies in EU
Med Device Manufacturers because they offer a will vote for the standard as both an EN and ISO
clear cut route to conformity to MDD’s & CE and then adopt said standard as an EN.
marking of product.

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ISO Technical Committee 198
Sterilization of Health Care products
Working Groups Current Processing Standards
European Standards International Standards
Committee Title
TC 198/WG 1 Industrial ethylene oxide sterilization TC 204 TC 198
TC 198/WG 2 Radiation sterilization „ ISO 11135.
„ EN 550 - EO
TC 198/WG 3Moist
3Moist heat sterilization „ TC 198 wg 1.
TC 198/WG 4 Biological indicators „ EN 552 - Irradiation „ Sterilization by EO will become EN
TC 198/WG 5 Terminology „ EN 554 – Moist Heat ISO 11135 parts 1 and 2.
TC 198/WG 6 Chemical indicators „ ISO 11137.
TC 198/WG 7 Packaging „ TC 198 wg 2.
TC 198/WG 8 Microbiological methods „ Sterilization by Irradiation will
TC 198/WG 9 Aseptic processing become EN ISO 11137 parts 1 to 3.
TC 198/WG 10 Liquid chemical sterilization
TC 198/WG 11 General criteria for sterilization processes
„ ISO 11134 & ISO 13683.
TC 198/WG 12 Information for reprocessing of re-sterilizable devices „ TC 198 wg 3.
TC 198/WG 13 Washer-disinfectors „ Sterilization by Moist Heat will
become EN ISO 17665.

Revision of the Processing Standards ISO 14937


Under The Vienna Agreement with ISO lead „ Sterilization of health care products –
„ They will all have a common format. General requirements for
„ Following that used in ISO 14937. characterisation of a sterilizing agent
„ They will all use consistent definitions. and the development, validation and
„ Using those defined in ISO TS 11139. routine control of a sterilization process
„ They will all have common Quality System for medical devices.
Elements.
„ Based on reference to ISO 13485.

ISO 14937 – Sections ISO 14937 – Sections


ƒ Quality system elements ƒ Validation
ƒ Sterilizing agent characterisation ƒ (IQ, OQ, PQ, Review and approval)
ƒ (Agent definition, Microb effectiveness, Material compat,
compat, ƒ Routine control and monitoring
Safety & Env)
Env) ƒ (Product presentation, Process monitoring, Record
ƒ Process / equipment characterization generation)
ƒ (Process definition, Equipment specification) ƒ Product release from sterilization
ƒ Product definition ƒ (Record Review, Indicator Tests, Product disposition,
(Product spec, Packaging mtls, Corrective action)
ƒ mtls, Product quality prior to
sterilization) ƒ Maintaining process effectiveness
ƒ Process definition ƒ (Product Quality prior to Steril,
Steril, Calibration,
ƒ (Development, Biological safety, Process residuals, Product Maintenance, Requalification.)
Requalification.)
compat,
compat, Resteril)
Resteril)

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Moist Heat Sterilization
& Standards Involved
¾ EN 554 – Validation and Routine Control of Sterilization by Moist Heat
ISO 17665 ¾ ISO 11134-
11134- Validation & Routine Control – Industrial Moist Heat Sterilization.
. ¾ ISO 13683 – Validation & Routine Control Of Moist Heat Steril.
Steril. In HC Facilities.

¾ revised and consolidated into:


¾ ISO 17665 – Requirements for the development, validn.
validn. &
routine cont. of sterilization processes for med. Dev. – Moist heat.
¾ A single standard for all moist heat processes
used in Pharma,
Pharma, Medical Device & Health Care
sectors following the format of ISO 14937

Current Status ISO 17665 - Scope


¾ EN ISO 17665:2006 „ Specifies requirements for the development,
¾ NOW PUBLISHED validation and routine control of a moist heat
sterilization process for medical devices.
¾ 17665 – 2, Guidance „ Although the scope of this standard is limited to medical devices,
devices, it
specifies requirements and provides guidance that may be applicable
applicable
¾ to follow early 2007 to other health care products.
¾ Note: 3 year transition „ Moist heat sterilization processes covered by this
period before EN 554 standard include but are not limited to:
withdrawn „ a) saturated steam venting systems;
„ b) saturated steam active air removal systems;
„ c) air steam mixtures;
„ d) water spray; and
„ e) water immersion.

ISO 17665 - Scope ISO 17665 – Structure


ISO 17665 -1
Requirements
Pharmaceutical Pharmaceutical
Industry Industry ISO 17665 -1
Guidance
USA EU Very Brief explanation
of sections
(AAMI / FDA) (EP)
ISO TS 17665 - 2
Guidance
Comprehensive
Health Care Health Care General Guidance

(Hospital, Dental, GPO) (Hospital, Dental, GPO)


Annex A Annex B Annex C Annex D
USA EU Specific Specific Specific Specific
(AAMI) (CEN) Guidance
HC/EU
Guidance
US / Industry
Guidance
Canadian HC
Guidance
?

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ISO 17665 vs EN 554 Format Clause structure:
ISO 17665 (after 14937) EN 554 „ Document format revised so that each
Quality System.
¾
¾ Sterilizing Agent
¾ General (Personnel, Product
compatibility, Product
section covers specific processes when
Characterisation. Storage, Equipment, Process, appropriate.
¾ Process/Equipment Instruments, Maintenance)
Characterisation. ¾ Validation (Commissioning,
„ General – applicable to all processes
¾ Product Definition. PQ, Re-
Re-Comms.)
Comms.) „ Saturated steam processes eg porous load
¾ Process Definition.
¾ Process Control & Monitoring
¾ Validation. „ Steam supply is the primary steriliant
(Process Control, Routine
¾ Routine Control & Monitoring. Monitoring & Testing, „ Contained product processes eg pharma
¾ Product Release from Records)
Sterilization. „ Steam supply acts as a heat transfer medium
¾ Product Release from
¾ Maintenance of Process Sterilization
Effectiveness.
¾ GUIDANCE
¾ GUIDANCE – will be a new std

Considerations from revision process: Considerations from revision process:


1. “all embracing”. 3. Apparent redundant sections.

¾ The new document is trying to be all embracing ¾ Sterilizationusing heat in the presence of
covering such diverse processes as: moisture is a well understood process with a
¾ Air ballasted processes used in the Pharma industry long reliable history dating back over 200
for flexible IV containers where residual chamber air years.
is essential to prevent product damage ¾ The sections covering
¾ To: ¾ Sterilizing
Agent Characterisation,
¾ Porous Load processes used in hospitals for reusable ¾ Sterilizing
Agent specification &
surgical packs where residual chamber air is ¾ microbicidal effectiveness
dangerous and can compromise attainment of ¾ appear redundant.
sterility.

Considerations from revision process: Considerations from revision process:


4. Clauses appear vague requiring interpret . 5. Steam Penetration test omitted .
¾ The original documents omitted the steam
¾ Because of the general nature of the
penetration test totally ignoring one of
document the clauses often appear too the fundamental tests of equipment
general requiring extensive explanation in capability.
the Guidance which in turn requires ¾ This has been corrected and clauses
interpretation in its annexes. covering the steam penetration test are
¾ Anticipated that local regional application now included in several sections.
documents will also arise ¾ The Guidance document includes
¾ Eg in UK DoH will publish revised HTM 0101 extensive discussion on suitable steam
penetration test devices.

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Considerations from revision process: Considerations from revision process:
5. Steam Penetration test omitted . 6. The document describes the use of BI’s
¾ Unlike EN 554 the new document describes
„ The Guidance document also explains why process definition and monitoring based on
the correlation of temperature and the use of Biological Indicators as an option.
pressure with steam table values cannot ¾ Whilst this is a common approach in the
be used as an alternative to conducting a Pharma industry it will be interesting to see if
steam penetration test. the Medical Device & Health Care sectors
embrace the approach.
¾ One can anticipate some interesting cycle
definitions being used if they do (eg
(eg 134 C for a
few seconds).

Large Steam Sterilizers Standards Affected


& „ EN 285 – Sterilization – Steam
EN 285 Sterilizers – Large Sterilizers.
„ Has been revised under the 5 year
revision rule by CEN TC 102 wg 2/3
„ Note : Is not an ISO but rather a
harmonised EU standard.

Current Status Issues Arising from the revision:


1. Cannot Be Prescriptive

EN 285: 2006 „ A new directive from CEN means that


standards cannot be prescriptive.
IS NOW „ Standards should contain requirements
PUBLISHED. which must be fulfilled but must not
describe how they can be fulfilled
allowing manufacturing flexibility.
„ 1995 document described lots of tests
which manufacturers found useful and
which were used during type testing.
These have been diluted from
mandatory to reference tests.

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Issues Arising from revision: Issues Arising from revision:
2. Focus is on Design 3. Attempt to remove steam tests.

„ 1995 version covered type & works testing, „ Attempts were made to have the steam
IQ and some routine monitoring. quality tests and the Bowie and Dick Test
„ New standard focuses on design and factory deleted from the document.
testing. „ This was being driven by the US
„ Useful IQ and routine tests have been Pharmaceutical Industry who have
moved to an informative annex. questioned the relevance and applicability of
„ ISO 17665 will cover IQ,OQ, PQ & routine the steam quality and Bowie and Dick tests.
monitoring. „ The document still contains these valuable
daily tests.

Issues Arising from revision:


4. Introduction of a Hollow Load PCD Test. Round Robin tests - Outcome
The German delegation tabled a proposal to
„ Committee reviewed results and decided there
„
introduce an additional performance test similar to
the Hollow Load A test described in EN 867-
867-5. was a need for:
„ It was suggested that a sterilizer meeting all of the „ Hollow Load Test
current EN 285 requirements may not be able to
remove residual air from hollow instruments and and
therefore sterilize them. „ Standard Textile Bowie & Dick test
„ An ad hoc group was formed to investigate the „Because the textile pack is sensitive to certain process
performance of the Hollow Load test in large failures which the helix test is not and vice versa
sterilizers and compare it to the BDT, the rubber
load test and three surrogate devices designed to „ Outcome : publish an amendment to 285 to replace
mimic hollow / cannulated surgical instruments. rubber load test, which was shown to be impractical
and insensitive to residual air, with Helix Test.
„ The amendment is currently out for vote
„ – deadline 13th Dec 2006 .

Hollow Load PCD – Issues Arising from revision:


4. Introduction of modified thermocouple
EN 867-5 pattern for small load test .

„ A thin tube 1500mm long with a capsule at „ The German delegation tabled a proposal to modify
one end for placement of an indicator. the thermocouple arrangements in the small load
thermometric test to include additional sensors in
the pack.
„ Wall Thickness = 0.5 +/-
+/- 0.025mm „ The reason for this is that there is evidence to show
„ Internal Diam.
Diam. = 2.0 +/-
+/- 0.1 mm that if an air pocket forms in a textile pack it can be
off centre. Thus a sensor placed in the geometric
„ Length = 1500 +/-
+/- 15 mm centre of the pack may not detect the lowest
„ Capsule Mass = 10.0 +/-
+/- 0.1g temperature depression present.
„ Free Capsule Vol = 6 +/-
+/- 1% of tot int vol „ For this reason a new arrangement has been
introduced which places sensors at different
„ Material = PTFE locations positioned along the vertical axis.

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The air pocket The air pocket
- Temperature profile
Research shows the air pocket’s form
is not a perfect ball, but egg shaped. „ Temperature profile
from within a textile
pack exposed to a sub
atmospheric pulsing
cycle with set points of
275mB – Fail cycle.

Small Load thermometric Test


Introduction of multiple sensors inside pack
Biological and
EN 285:1996
Chemical Sterilization
„ specifies three sensors
„ shown in red plus ref point
Indicator Standards
EN285:2006
„ Specifies seven sensors
„ Six shown plus ref point
„ HIGHLY
CONTROVERSIAL !!!

Definition of a BI & scope Current BI & CI Standards


„ BI - A microbiological test system „ EN 866 / ISO 11138 – Biological Indicators.
providing a defined resistance to a „ EN 867 /ISO 11140 – Chemical Indicators.
specified sterilization process.
„ Scope – Covers biological test systems
which depend for their function on the
demonstration of viability of a test
organism (however this is determined).

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EN 866 & ISO 11138 parts BI – changes to docs
„ Both sets of docs were combined using EN
EN 866 ISO 11138
format – ISO cmmt taking lead.
„ Pt 1 - General Requirements „ Pt 1 – General Requirements
„ Pt 2 – Reqs for EO BI’s „ Pt 2 – Reqs for EO BI’s „ Part 4 – Irrad BI deleted (Irradiation industry
„ Pt 3 – Reqs for Moist Heat BI’s „ Pt 3 – Reqs for Moist Heat BI’s does not want reference to BI’s).
„ Pt 4 – Reqs for Irradiation BI’s „ Part 7 & 8 deleted - Self Contained parts of EN
„ Pt 5 – Reqs for LTSF BI’s (7 & 8) combined with parts 2 & 3 of new
„ Pt 6 – Reqs for Dry Heat BI’s document.
„ Pt 7 – Reqs for Moist Heat SC’s
„ Bacillus subtilis renamed to B. atrophaeus
„ Pt 8 – Reqs for EO SC’s BI’s
„ Bacillus stearothermophilus renamed to
Geobacillus stearo.
stearo.
„ New term Fbio introduced = D x logP

BI’s – Current status: Definition of a CI & Scope


„ All parts of 11138: 2006 now published
„ CI – System that reveals a change in one
„ Pt 1 – General requirements or more predefined process variables
„ Pt 2 – BI’s for EO based on a chemical or physical change
„ Pt 3 – BI’s for Moist Heat resulting from exposure to a process.
„ Pt 4 – BI’s for Dry Heat „ Scope – Covers test systems which are
„ Pt 5 – BI’s for LTS&F not dependent for their action on the
detection of the presence or absence of
living organisms.

EN 867 and ISO 11140 parts CI – changes to docs


EN 867 ISO 11140 „ ISO 11140 pt 1 contains specific requirements
„ Pt 1 – General Requirements „ Pt 1 – General Requirements for class 1 & 3 to 6 indicators. This has been
„ Pt 2 – Process Indicators „ Pt 2 – Test Equipment & Methods combined with pts 1 and 2 of EN 867.
„ Pt 3 – Bowie and Dick Test Sheets „ Pt 3 – Bowie & Dick Test Sheets „ ISO 11140 pt 2 has been revised and combined
„ Pt 4 – Alternative BDT packs „ Pt 4 – Alternative BDT packs with the BI BIER vessel specification creating a
„ Pt 5 – Indicator systems and PCD’s „ Pt 5 – BDT sheets and alternative single test vessel standard for both CI’s and BI’s
for small steam sterilizers. packs (US sensitivity).
ISO 18472
„ Classification as per ISO ie 1 to 6 not A to D.
„ Section covering integrators completely revised
to align more closely with function ie equivalency
to biological indicators.

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CI’s – Current Status – Oct 06. Test Equipment for CI’s & BI’s
„ ISO 11140-
11140-1 Published. „ The requirements for the test
equipment (BIER / CIER vessels) will be
„ ISO 11140-
11140-2 deleted from ISO 11138 & 11140 and
Currently replaced by ISO 18472.
„
combined and harmonised into a single
„ Likely to become the replacement for EN 867-
867-5 now in
revision new standard, ISO 18472, covering test
„ ISO 11140-
11140-3 to 5 equipment specification for testing CI’s
„ BDT standards and BI’s
„ Awaiting publication as FDIS.

CI’s – Guidance on selection &


use of CI’s – ISO 15882 CI classes
„ Class 1 – Process Indicators
„ Published but in revision. „ Used to show exposure to a process. No information about the
success or failure of the process
„ Gives guidance on 11140 part 1 to 5 „ Class 2 – Specific Test Indicators (eg
(eg BDT)
Class 3 – Single variable indicators
explaining the different classes and „
„ Respond to a single variable in the process eg temperature.
requirements for each class. „ Class 4 – Multivariable Indicators
„ Respond to two or more variables in the process
„ In process of revision during 2006 /07. „ Class 5 – Integrating Indicators (Chemical Biological Indicators)
„ Respond in a way which mimics the response of a BI if used in the the
same process.
„ Class 6 – Emulating Indicators (Cycle Verification Indicators -Chemical
Chart Recorders)
„ Respond to all critical variables of the process at levels associated
associated
with acceptable sterilizing conditions eg 134 for 3 mins.
mins.

An explanation of integrators
Explanation of integrators Class 5
ISO 11138-
11138-3, biological indicator for moist heat:
„ D 121 is not less than 1.5 mins
„ Population is not less than 1 x 10 5
„ z is not less than 6
„ For Geobacillus stearothermophilus z typically = 10.
„ To achieve a 10 -6 inactivation level in a BI having these
characteristics we need an exposure time of 16.5 mins at
121C
„ (11 log reductions , 11 x 1.5 = 16.5 mins).
mins).
„ Survivors would be expected to be seen at 7 log reductions
(10 -2)
„ ( 7 x 1.5 = 10.5 mins )

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An explanation of emulators, An explanation of emulators
class 6 Class 6 Test Point - Pass

„ Emulators are indicators which should show Pass


that a defined set of cycle parameters have 134
been attained and no other Test Point - Fail
133
„ eg 134 C for 3 mins.
mins. (this is the stated value)
„ ISO 11140 requires: Fail
„ a Pass at the stated value eg 134 C for 3 mins
„ a Fail at svT -1C and svt – 6% eg 133 C for 2’ 50’’

Emulators Stated Value = 2’50’’ 3’0’’


3 mins at 134 oC

The UK guidance Estates and Facilities Division


„ NHS Estates no longer exists. „ Engineering „ Guidance
Technology and Strategic
„ New division within DoH – „
Environs Programmes
„ Department of Health Estates and Facilities
„ Design and Costing implementing policy
Division.
„ Strategic Estate „ Governance
„ Role: Mgmt
„ New Health Technical Memoranda
„ Professional Roles and Responsibilities

Estates and Facilities NEW HTM’s


„ Willfocus on policy and strategy „ Refresh and Update over 190 existing
„ Key personnel: documents
„ Ken Holmes – Public Health Engineer „ To provide NHS with a suite of usable health
specific reference documents.
„ Infection Control
„ Reviewed and split into 9 core topics
„ Decontamination
„ Assessed content against new legislation and
„ Specialist Ventilation standards
„ Legionella „ Re Scoped guidance content
„ Med gases. „ Prioritised role out in accordance with gov policy

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New HTMs HTM 00 – Policy and Principals
„ Nine core documents 1. 1
„ 00 – Core Policy 2. Overview of all htms
„ 01 – Decontamination 3. Statutory requirements
„ 02 – Medical gases
4. Professional & technical support
„ 03 – Ventilation
„ 04 – Water 5. Operational policy / user involvement
„ 05 – Fire 6. Emergency preparedness
„ 06 – Electrical 7. Staff training, systems, maintenance
„ 07 – Environment 8. Optimisation of engineered systems
„ 08 – Specialist 9. Design and access availability

HTM 01-01 Decontamination


of Reusable Medical Devices HTM0101
„ Part A Mgmt & „ Part B – Equipment „ Consolidates previous documents into
Environs „ Sterilizers
one
Design and Prepurchase
Management
„
„
„ Validation and Verification „ HTM 2010, 2030, 2031
„ Decontamination „ Steam supply
Management „ Operational Mgmt „ HBN 13
Buildings and Washer Disinfectors
„ Model Engineering Specs, 14,15, 30 etc
„ „
Environment „ Design and Prepurchase
„ Validation and Verification „ Other guidance docs
„ Water Supply
„ Operational Mgmt

HTM 01-01 – Current Status


Responsibility Structure Dec06
Designated Person „ HTM00 will be published December
Appointed Senior Exec at Board level „ HTM0101-
HTM0101-A – reviewed and amended
with responsibility for service
„ Planned for publication before end Mar 07
AE(D) Trust Ops Mgr „ HTM0101-
HTM0101-B – comment period just finished
AP(D) „ Planned for publication end Mar 07
Trust employed qualified „ NOTE – great concern regarding content of
technical engineer part B especially
CP(D)
Craftsperson for testing and
maintenance

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THE END
ANY QUESTIONS ?

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