SIST EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process
simulations for the qualification of the aseptic processing of medical devices and combination products that cannot
be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic
process to design a process simulation study for medical devices and combination products in those cases
where a straightforward substitution of media for product during aseptic processing is not feasible or would not
simulate the actual aseptic process.

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 7: Alternative Verfahren für Medizinprodukte und Kombinationsprodukte (ISO 13408-7:2012)

Dieser Teil von ISO 13408 legt Anforderungen an alternative Ansätze zur Verfahrenssimulation für die Qualifizierung der aseptischer Herstellung von Medizinprodukten und Kombinationsprodukten fest, die nicht in der Endverpackung sterilisiert werden können und bei denen der Ansatz für die Verfahrenssimulation nach ISO 13408-1 nicht angewendet werden kann, und stellt einen Leitfaden dafür zur Verfügung.
Dieser Teil von ISO 13408 beschreibt, wie die Risikobeurteilung während der Entwicklung eines aseptischen Verfahrens verwendet werden kann, um eine Studie zur Verfahrenssimulation für Medizinprodukte und Kombinationsprodukte in den Fällen zu planen, in denen ein direkten Ersatz des Produktes durch Medien während der aseptischen Herstellung praktisch nicht möglich ist oder nicht das tatsächliche aseptische Verfahren simulieren würde.

Traitement aseptique des produits de santé - Partie 7: Procédés alternatifs pour les dispositifs médicaux et les produits de combinaison (ISO 13408-7:2012)

L'ISO 13408-7:2012 indique les exigences et recommandations concernant les approches alternatives des simulations de procédé pour la qualification du traitement aseptique des dispositifs médicaux et produits combinés qui ne peuvent subir une stérilisation finale et lorsque l'approche de l'ISO 13408-1 ne peut être appliquée.
L'ISO 13408-7:2012 décrit de quelle manière l'évaluation des risques peut servir lors de l'élaboration d'un procédé aseptique afin de concevoir une étude de simulation de procédé pour dispositifs médicaux et produits combinés dans les cas où une simple substitution du produit par un milieu de culture lors du traitement aseptique n'est pas possible ou ne simulerait pas le véritable procédé aseptique.

Aseptična proizvodnja izdelkov za zdravstveno nego - 7. del: Alternativni procesi za medicinske pripomočke in kombinirane izdelke (ISO 13408-7:2012)

Ta del standarda ISO 13408 določa zahteve in podaja smernice za alternativne pristope k simulacijam postopkov za kvalifikacijo aseptične proizvodnje medicinskih pripomočkov in kombiniranih izdelkov, ki jih ni mogoče končno sterilizirati in pri katerih ni mogoče uporabiti pristopa simulacije postopka v skladu z ISO 13408-1. Ta del standarda ISO 13408 opisuje, kako je mogoče uporabiti oceno tveganja med razvojem aseptične proizvodnje za načrtovanje študije simulacije postopka za medicinske pripomočke in kombinirane izdelke, kadar neposredna zamenjava medija za izdelek med aseptično proizvodnjo ni mogoča ali ne bi simulirala dejanske aseptične proizvodnje.

General Information

• Status: Published
• Public Enquiry End Date: 29-Apr-2015
• Publication Date: 07-Sep-2015
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Aug-2015
• Due Date: 24-Oct-2015
• Completion Date: 08-Sep-2015
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Ref Project: EN ISO 13408-7:2015 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13408-7:2015
01-oktober-2015
$VHSWLþQDSURL]YRGQMDL]GHONRY]D]GUDYVWYHQRQHJRGHO$OWHUQDWLYQLSURFHVL
]DPHGLFLQVNHSULSRPRþNHLQNRPELQLUDQHL]GHONH,62
Aseptic processing of health care products - Part 7: Alternative processes for medical
devices and combination products (ISO 13408-7:2012)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 7: Alternative
Verfahren für Medizinprodukte und Kombinationsprodukte (ISO 13408-7:2012)
Traitement aseptique des produits de santé - Partie 7: Procédés alternatifs pour les
dispositifs médicaux et les produits de combinaison (ISO 13408-7:2012)
Ta slovenski standard je istoveten z: EN ISO 13408-7:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 13408-7:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13408-7:2015

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SIST EN ISO 13408-7:2015

EUROPEAN STANDARD
EN ISO 13408-7

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2015
ICS 11.080.01
English Version
Aseptic processing of health care products - Part 7: Alternative
processes for medical devices and combination products (ISO
13408-7:2012)
Traitement aseptique des produits de santé - Partie 7: Aseptische Herstellung von Produkten für die
Procédés alternatifs pour les dispositifs médicaux et les Gesundheitsfürsorge - Teil 7: Alternative Verfahren für
produits de combinaison (ISO 13408-7:2012) Medizinprodukte und Kombinationsprodukte (ISO 13408-
7:2012)
This European Standard was approved by CEN on 30 July 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-7:2015 E
worldwide for CEN national Members.

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SIST EN ISO 13408-7:2015
EN ISO 13408-7:2015 (E)
Contents
Page
European 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

2

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SIST EN ISO 13408-7:2015
EN ISO 13408-7:2015 (E)
European foreword
The text of ISO 13408-7:2012 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 13408-7:2015 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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 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 and ZC, which are integral parts of this
document.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced document (including any amendments) listed below applies. For
dated references, only the edition cited applies. However, for any use of this standard within the meaning of
Annex ZA, ZB or ZC, the user should always check that any referenced document has not been superseded
and that its relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the
ISO or IEC standard as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.

Table – Correlation between normative references and dated EN and ISO standards

Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 13408-1:2008 EN ISO 13408-1:2015 ISO 13408-1:2008

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13408-7:2012 has been approved by CEN as EN ISO 13408-7:2015 without any modification.
3

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SIST EN ISO 13408-7:2015
EN ISO 13408-7:2015 (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
implemented as a national standard in at least one Member State, compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that risks
have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according
to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements 1,
4, 5, 8, 9 and 10 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword,
replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 90/385/EEC
4,5,6,7,8,9,10,11 7 Only attainment of sterility by aseptic processing is
considered by this standard.
This relevant Essential Requirement is only partly
addressed in this European Standard. Design and
packaging for maintenance of sterility during
transportation and storage are not covered. Aspects of
manufacture other than those related to aseptic
processing are not covered.

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this Standard.
4

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SIST EN ISO 13408-7:2015
EN ISO 13408-7:2015 (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 normative clauses of
this 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that risks have
to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the
wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements 1,
2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword,
replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
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
4,5,6,7,8,9,10,11 8.3 Only attainment of sterility by aseptic processing is
considered by this standard.
This relevant Essential Requirement is only partly
addressed in this European Standard. Design and
packaging for maintenance of sterility during
transportation and storage are not covered.
Aspects of manufacture other than those related
to aseptic processing are not covered.
4,5,6,7,8,9,10,11 8.4 This relevant Essential Requirement is only partly
addressed in this European Standard. Aspects of
manufacture other than those related to aseptic
processing are not covered.

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this Standard.
5

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SIST EN ISO 13408-7:2015
EN ISO 13408-7:2015 (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
implemented as a national standard in at least one Member State, compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with 98/79/EC. This means that risks have to be reduced ‘as far as
possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to the wording of the
corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements
Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6, and 7 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword,
replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
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
4,5,6,7,8,9,10,11 B.2.3 Only attainment of sterility by aseptic
processing is considered by this
standard.
This relevant Essential Requirement is
only partly addressed in this European
Standard. Design and packaging for
maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture other
than those related to aseptic
processing are not covered.
4,5,6,7,8,9,10,11 B.2.4 This relevant Essential requirement is
addressed in this International
Standard only with regard to:
- aseptic processing to attain sterility,
not covering other special
microbiological state
- medical devices for which aseptic
processing is appropriate

WARNING — Other requirements and other EU Directives may be applicable to the
product(s) falling within the scope of this Standard.
6

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SIST EN ISO 13408-7:2015
INTERNATIONAL ISO
STANDARD 13408-7
First edition
2012-08-01
Aseptic processing of health care
products —
Part 7:
Alternative processes for medical devices
and combination products
Traitement aseptique des produits de santé —
Partie 7: Procédés alternatifs pour les dispositifs médicaux et les
produits de combinaison
Reference number
ISO 13408-7:2012(E)
©
ISO 2012

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SIST EN ISO 13408-7:2015
ISO 13408-7:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 13408-7:2015
ISO 13408-7:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality system elements . 2
5 Aseptic process definition . 2
5.1 General . 2
5.2 Risk management . 2
6 Manufacturing environment . 3
7 Equipment . 3
8 Personnel . 3
9 Manufacture of the product . 3
10 Process simulation . 3
10.1 General . 3
10.2 Media selection and growth support. 3
10.3 Simulation procedures . 3
10.4 Incubation and inspection of process simulation units . 6
10.5 Initial performance qualification . 6
10.6 Periodic performance requalification . 6
10.7 Repeat of initial performance qualification . 7
10.8 Documentation of process simulations . 7
10.9 Disposition of filled product . 7
11 Test for sterility . 7
11.1 General . 7
11.2 Investigation of positive units from tests for sterility . 7
Annex A (informative) Risk assessment for aseptic processing — Quality risk management method . 8
Annex B (informative) Selection of a sample for testing for microbial contamination .15
Annex C (informative) Testing options for process simulation .16
Bibliography .19
© ISO 2012 – All rights reserved iii

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SIST EN ISO 13408-7:2015
ISO 13408-7:2012(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.
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 13408-7 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
— Part 7: Alternative processes for medical devices and combination products
iv © ISO 2012 – All rights reserved

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SIST EN ISO 13408-7:2015
ISO 13408-7:2012(E)
Introduction
ISO 13408 is the International Standard, published in a series of parts, for aseptic processing of health care
products. Historically, sterile health care products that are aseptically produced have typically been liquids,
powders or suspensions that cannot be terminally sterilized. More recently, medical devices and health care
products have been developed that are combined with medicinal products, including biological and viable cells,
that cannot be terminally sterilized.
The application of ISO 13408-1 to these medical devices and combination products can require the development
of alternative approaches to process simulation. This part of ISO 13408 specifies requirements and provides
guidance for developing such alternative approaches for the qualification of aseptic processes through process
simulation of medical devices and combination products that meet the requirements of ISO 13408-1.
ISO 13408-1:2008, 10.1.2 permits the use of alternative process simulation approaches, based on particular medical
devices or combination products, where the substitution in full with sterile liquid media might not be possible.
Medical devices and combination products that typically require aseptic processing might include, for example,
the following.
a) Medical devices that cannot be terminally sterilized and where the process simulation approach according
to ISO 13408-1 cannot be applied:
— bioprostheses (e.g. heart valves, vascular implants);
— biodegradable implants (e.g. hernia meshes);
— artificial and/or non-viable biologically based matrixes;
— extracorporeal processing devices (e.g. immuno-adsorbers);
— implantable osmotic pumps;
— hermetically sealed electromechanical devices and partially enclosed electronic devices (e.g. invasive
and non-invasive diagnostic devices).
b) Combination products (including viable cell-based combination products):
— implants coated with drug and/or biologically derived substances (e.g. drug-coated stents, carrier
materials with protein, bone-graft material with growth factors, biodegradable drug-coated stents);
— wound dressings (e.g. dressings with haemostatic agents, tissue sealants, or biologics);
— transdermal or injectable delivery systems (e.g. drug-coated or biologics interstitial patches);
— kits containing a biological or drug component (e.g. demineralized bone matrices).
For such products, a risk management strategy and method(s) can be used for the identification, evaluation and
quantification (estimation) of contamination risks throughout the entire product/process life cycle. Environmental
monitoring and microbiological studies can be performed on individual steps of the process to evaluate the
effectiveness of contamination controls and risk mitigations. The design of the process simulation can then be
driven by the results of the risk analysis. If the results of the process simulation are acceptable, this provides
evidence that the aseptic process is in a state of contamination control (i.e. no extrinsic microbiological/microbial
contamination has been introduced during the aseptic process).
This part of ISO 13408 should be read in conjunction with ISO 13408-1.
Within this International Standard, text that supplements ISO 13408-1 by providing additional requirements or
guidance is identified by the prefix “Addition”.
© ISO 2012 – All rights reserved v

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SIST EN ISO 13408-7:2015

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SIST EN ISO 13408-7:2015
INTERNATIONAL STANDARD ISO 13408-7:2012(E)
Aseptic processing of health care products —
Part 7:
Alternative processes for medical devices and combination
products
1 Scope
This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process
simulations for the qualification of the aseptic processing of medical devices and combination products that cannot
be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic
process to design a process simulation study for medical devices and combination products in those cases
where a straightforward substitution of media for product during aseptic processing is not feasible or would not
simulate the actual aseptic process.
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 13408-1:2008, Aseptic processing of health care products — Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13408-1 and the following apply.
3.1
extrinsic contamination
ingress of material of external origin during the manufacturing process
NOTE The focus of extrinsic contamination in this part of ISO 13408 is biological agents e.g. bacteria, mould, yeast.
3.2
process simulation
exercise that simulates the manufacturing process or portions of the process in order to demonstrate the
capability of the aseptic process to prevent biological contamination
3.3
risk management
systematic application of quality management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring risk
[ISO 14971:2007, definition 2.22]
3.4
surrogate product
item designed to represent product in process simulations and which is comparable to the actual product
© ISO 2012 – All rights reserved 1

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SIST EN ISO 13408-7:2015
ISO 13408-7:2012(E)
4 Quality system elements
ISO 13408-1:2008, Clause 4 applies.
5 Aseptic process definition
5.1 General
ISO 13408-1:2008, 5.1 applies.
5.2 Risk management
5.2.1 General
ISO 13408-1:2008, 5.2.1 applies with the following additional requirements.
a) Risk assessment shall consider all steps of the aseptic process and determine whether the aseptic process is to
be simulated in one continuous process or divided into sub-processes for the purposes of process simulation.
Risk assessment shall not be used to justify the simulation of only some but not all of the processes of an
aseptic process.
NOTE 1 Successful process simulation provides evidence of the capability of the specified aseptic process to
produce an acceptable overall residual risk of microbiological/microbial contamination.
NOTE 2 The risk ass
...