Irish Standard

I.S. EN ISO 13408-5:2011

Aseptic processing of health care

products - Part 5: Sterilization in place
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(ISO 13408-5:2006)

© NSAI 2011 No copying without NSAI permission except as permitted by copyright law.
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I.S. xxx: Irish Standard – national specification based on the consensus of an expert panel and
subject to public consultation.

S.R. xxx: Standard Recommendation - recommendation based on the consensus of an expert

panel and subject to public consultation.

SWiFT xxx: A rapidly developed recommendatory document based on the consensus of the
participants of an NSAI workshop.

EN 13824:2004

EN ISO 13408-5:2011 5 July, 2011

EN 13824:2004 24 November, 2004

This document was published ICS number:

under the authority of the NSAI 11.080.01
and comes into effect on:
5 July, 2011

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 I.S. EN ISO 13408-5:2011

EUROPEAN STANDARD EN ISO 13408-5

NORME EUROPÉENNE
EUROPÄISCHE NORM June 2011

ICS 11.080.01 Supersedes EN 13824:2004

English Version

Aseptic processing of health care products - Part 5: Sterilization

in place (ISO 13408-5:2006)

Traitement aseptique des produits de santé - Partie 5: Aseptische Herstellung von Produkten für die
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Stérilisation sur place (ISO 13408-5:2006) Gesundheitsfürsorge - Teil 5: Sterilisation vor Ort (ISO
13408-5:2006)

This European Standard was approved by CEN on 10 June 2011.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-5:2011: E
worldwide for CEN national Members.
 I.S. EN ISO 13408-5:2011
EN ISO 13408-5:2011 (E)

Contents Page

Foreword ..............................................................................................................................................................3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ......................4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .........................................................5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices............................6
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2
 I.S. EN ISO 13408-5:2011
EN ISO 13408-5:2011 (E)

Foreword
The text of ISO 13408-5:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 13408-5:2011 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat
of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by December 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 13824:2004.

This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directives.

For relationship with EU Directives, see informative Annexes ZA, ZB, or ZC, which are integral parts of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 13408-5:2006 has been approved by CEN as a EN ISO 13408-5:2011 without any
modification.

3
 I.S. EN ISO 13408-5:2011
EN ISO 13408-5:2011 (E)

Annex ZA
(informative)

Relationship between this European Standard and the Essential

Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices

This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
This is a free 15 page sample. Access the full version online.

implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC

Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes

Directive 90/385/EEC

4,5,6,7,8,9,10 7 This relevant Essential Requirement is

only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

4
 I.S. EN ISO 13408-5:2011
EN ISO 13408-5:2011 (E)

Annex ZB
(informative)

Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC on Medical Devices

This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
This is a free 15 page sample. Access the full version online.

standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes

Directive 93/42/EEC

4,5,6,7,8,9,10 8.3 This relevant Essential Requirement is

only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
4,5,6,7,8,9,10 8.4 This relevant Essential Requirement is
addressed in this European standard
only in conjunction with
EN ISO 13408-1

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

5
 I.S. EN ISO 13408-5:2011
EN ISO 13408-5:2011 (E)

Annex ZC
(informative)

Relationship between this European Standard and the Essential

Requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices

This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 98/79/EC on in vitro diagnostic medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
This is a free 15 page sample. Access the full version online.

implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC

Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes

Directive 98/79/EC

4,5,6,7,8,9,10 B.2.3 This relevant Essential Requirement is

only partly addressed in this European
Standard and only in conjunction with
EN ISO 13408-1
4,5,6,7,8,9,10 B.2.4 This relevant Essential Requirement is
addressed in this European standard
only in conjunction with
EN ISO 13408-1

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

6
 I.S. EN ISO 13408-5:2011
INTERNATIONAL ISO
STANDARD 13408-5

First edition
2006-11-15
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Aseptic processing of health care

products —
Part 5:
Sterilization in place
Traitement aseptique des produits de santé —
Partie 5: Stérilisation sur place

Reference number
ISO 13408-5:2006(E)

© ISO 2006
 I.S. EN ISO 13408-5:2011
ISO 13408-5:2006(E)

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ii © ISO 2006 – All rights reserved

 I.S. EN ISO 13408-5:2011
ISO 13408-5:2006(E)

Contents Page

1 Scope .................................................................................................................................................... 1
2 Normative references .......................................................................................................................... 1
3 Terms and definitions .......................................................................................................................... 2
4 Quality system elements ..................................................................................................................... 3
4.1 General ................................................................................................................................................. 3
4.2 Management responsibility ................................................................................................................ 3
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4.3 Design control ..................................................................................................................................... 3

4.4 Measuring instruments and measuring systems ............................................................................. 3
5 Process and equipment characterization .......................................................................................... 4
5.1 General concepts ................................................................................................................................ 4
5.2 Effectiveness of sterilization in place (SIP) ...................................................................................... 4
5.3 Equipment ............................................................................................................................................ 4
6 Sterilizing agent characterization ...................................................................................................... 6
6.1 Selection of sterilizing agent(s) ......................................................................................................... 6
6.2 Quality of sterilizing agent(s) ............................................................................................................. 6
6.3 Safety and the environment ............................................................................................................... 6
7 SIP process .......................................................................................................................................... 6
7.1 Process parameters ............................................................................................................................ 6
7.2 Cycle development .............................................................................................................................. 7
8 Validation .............................................................................................................................................. 7
8.1 Validation protocol .............................................................................................................................. 7
8.2 Design qualification ............................................................................................................................ 7
8.3 Installation qualification ..................................................................................................................... 7
8.4 Operational qualification .................................................................................................................... 8
8.5 Performance qualification .................................................................................................................. 8
8.6 Review and approval of validation ................................................................................................... 10
8.7 Requalification ................................................................................................................................... 10
9 Routine monitoring and control ....................................................................................................... 10
9.1 SIP process control ........................................................................................................................... 10
9.2 Procedures ......................................................................................................................................... 10
9.3 SIP process records .......................................................................................................................... 11
9.4 Change control .................................................................................................................................. 11
9.5 Maintenance of equipment ............................................................................................................... 11
10 Personnel training ............................................................................................................................. 11
Annex A (informative) Steam sterilization in place ................................................................................. 12
Bibliography ............................................................................................................................................... 14

© ISO 2006 – All rights reserved iii

 I.S. EN ISO 13408-5:2011
ISO 13408-5:2006(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
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The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 13408-5 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products :
— Part 1: General requirements
— Part 2: Filtration
— Part 3: Lyophilization
— Part 4: Clean-in-place technologies
— Part 5: Sterilization in place
— Part 6: Isolator systems

iv © ISO 2006 – All rights reserved

 I.S. EN ISO 13408-5:2011
ISO 13408-5:2006(E)

Introduction
During the process of preparing ISO 13408-1, several items, e.g. filtration, freeze drying and sterilization in
place, were found to be in need of supplementary information which was too voluminous to be given in
corresponding annexes.

This part of ISO 13408 includes requirements and guidance that are to be observed during sterilization in place.
The purpose of this part of ISO 13408 is to achieve standardization in the field of validation and routine control
of sterilization in place processes used in the manufacture of health care products.

Sterilization in place is, in most instances, preceded by cleaning in place which is described in ISO 13408-4.
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While methods of cleaning in place and sterilization in place differ considerably in technology, the concept of in
situ treatment is similar.

The most important issue to consider in establishing sterilization-in-place technology is the design of the
system(s) to ensure that they be able to successfully sterilize manufacturing equipment to the desired level of
sterility assurance.

© ISO 2006 – All rights reserved v

This is a free 15 page sample. Access the full version online.
I.S. EN ISO 13408-5:2011
 I.S. EN ISO 13408-5:2011
INTERNATIONAL STANDARD ISO 13408-5:2006(E)

Aseptic processing of health care products —

Part 5:
Sterilization in place

1 Scope
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1.1 This part of ISO 13408 specifies the general requirements for sterilization in place (SIP) applied to product
contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing
and offers guidance on qualification, validation, operation and control.

NOTE SIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steam
sterilization in place, which is the most common method used, is given in Annex A.

1.2 This part of ISO 13408 applies to processes where sterilizing agents are delivered to the internal surfaces
of equipment that can come in contact with the product.

1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to a
sterilizer.

1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good
Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional
jurisdictions.

1.5 This part of ISO 13408 does not specify requirements for development, validation and routine control of a
process for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovine
spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in
particular countries for the processing of materials potentially contaminated with these agents.

NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.

ISO 11138 (all parts), Sterilization of health care products — Biological indicators

ISO 11140 (all parts), Sterilization of health care products — Chemical indicators

ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements

ISO 13408-4, Aseptic processing of health care products — Part 4: Clean-in-place technologies

ISO 14161, Sterilization of health care products — Biological indicators — Guidance for the selection, use and
interpretation of results

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices

© ISO 2006 – All rights reserved 1

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