SIST EN ISO 13408-1:2024
(Main)Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2023)
Dieses Dokument legt die allgemeinen Anforderungen an Verfahren, Programme und Verfahrensweisen zur Entwicklung, Validierung und routinemäßigen Kontrolle der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung.
Dieses Dokument umfasst Anforderungen und einen Leitfaden in Bezug auf das Gesamtthema der aseptischen Herstellung.
Besondere Anforderungen und ein Leitfaden für verschiedene spezielle Prozesse und Verfahren in Bezug auf Sterilfiltration, Lyophilisierung, Technologien der Reinigung vor Ort (en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorensysteme sind in den anderen Teilen der Normenreihe ISO 13408 angeführt.
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO 13408-1:2023)
Le présent document spécifie des exigences générales et propose des recommandations en matière de procédés, de programmes et de modes opératoires pour le développement, la validation et le contrôle de routine du traitement aseptique des produits de santé.
Le présent document spécifie comprend des exigences et des recommandations relatives à la thématique générale du traitement aseptique.
Des exigences et des recommandations spécifiques relatives aux divers procédés et méthodes spécialisés de filtration stérilisante, de lyophilisation, de nettoyage in situ (CIP), de stérilisation in situ (SIP) et de systèmes isolateurs sont indiquées dans les autres parties de la série ISO 13408.
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO 13408-1:2023)
Ta dokument določa splošne zahteve ter ponuja smernice za procese, programe in postopke za razvoj, validacijo in rutinsko kontrolo aseptične proizvodnje izdelkov za zdravstveno nego.
Ta dokument vključuje zahteve in smernice v povezavi z aseptično proizvodnjo na splošno.
Posebne zahteve in smernice glede različnih specializiranih postopkov in metod, povezanih s sterilizacijsko filtracijo, liofilizacijo, tehnologijami čiščenja v zaprtih sistemih (CIP), sistemi za sterilizacijo (SIP) in izolatorskimi sistemi, so podane v drugih delih skupine standardov ISO 13408.
General Information
Relations
Overview
EN ISO 13408-1:2024 (ISO 13408-1:2023) specifies the general requirements and guidance for the development, validation and routine control of aseptic processing of health care products. Published by CEN as the European adoption of ISO 13408-1, this standard sets out high‑level expectations for processes, programs and procedures used to maintain aseptic conditions during manufacture of sterile medicines, medical devices and other health care products.
Key topics and requirements
- Scope and intent: General requirements and guidance for aseptic processing; not a replacement for product‑specific manufacturing controls.
- Process development: Framework for planning aseptic processes, including risk‑based approaches and procedural controls.
- Validation: Guidance on establishing and documenting validated aseptic processes prior to routine production.
- Routine control and monitoring: Expectations for ongoing environmental, personnel and process monitoring to maintain sterility assurance.
- Programs and procedures: Organization of standard operating procedures (SOPs), training, change control and quality oversight for aseptic operations.
- Interface to specialist methods: Identifies that sterilizing filtration, lyophilization, clean‑in‑place (CIP), sterilization‑in‑place (SIP) and isolator systems are covered in other parts of the ISO 13408 series (e.g., Part 2, Part 6).
- Regulatory linkage: Assists conformity with EU Regulations (e.g., Regulation (EU) 2017/745 and 2017/746) for applicable General Safety and Performance Requirements where aseptic processing is relevant.
Applications and who should use it
This standard is essential for:
- Pharmaceutical and biotech manufacturers implementing or improving aseptic filling and sterile product assembly.
- Medical device manufacturers producing devices requiring aseptic handling or sterile assembly.
- Quality assurance, validation and regulatory teams developing validation protocols, routine monitoring plans and compliance documentation.
- Facility design and operations teams aligning cleanroom practice, personnel flows and environmental control with aseptic requirements.
Use cases include process design, validation planning, writing SOPs for aseptic operations, and establishing monitoring programs to sustain sterility assurance during production.
Related standards
- ISO 13408-2 (Sterilizing filtration)
- ISO 13408-6 (Isolator systems)
- ISO 14644 series (Cleanrooms and associated controlled environments - notably Parts 1, 2, 4 and 7)
These referenced standards provide the detailed technical requirements for specific methods, cleanroom classification and separative devices that complement the general guidance in EN ISO 13408-1.
Keywords: aseptic processing, health care products, ISO 13408-1, EN ISO 13408-1:2024, validation, sterilizing filtration, lyophilization, CIP, SIP, isolator systems, cleanrooms, regulatory compliance.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve (ISO
13408-1:2023)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-
1:2023)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2023)
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO 13408
-1:2023)
Ta slovenski standard je istoveten z: EN ISO 13408-1:2024
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 13408-1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 13408-1:2015
English Version
Aseptic processing of health care products - Part 1:
General requirements (ISO 13408-1:2023)
Traitement aseptique des produits de santé - Partie 1: Aseptische Herstellung von Produkten für die
Exigences générales (ISO 13408-1:2023) Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO 13408-1:2023)
This European Standard was approved by CEN on 2 July 2023.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13408-1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 8
European foreword
This document (EN ISO 13408-1:2024) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13408-1:2015.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA and ZB, which is an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 13408-1:2023 has been approved by CEN as EN ISO 13408-1:2024 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance 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 Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Performance Requirements Clause(s)/sub-clause(s) of
Remarks/Notes
of Regulation (EU) this EN
2017/745
11.3 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Aspects of manufacture other
than those related to maintenance of a
specific microbial state by aseptic
processing are not covered.
11.4 first sentence only 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Evidence that the integrity of
the packaging is maintained to the point of
use is not covered. Aspects of manufacture
other than those related to maintenance of
sterility during aseptic processing are not
covered. Transport and storage conditions
are not covered.
11.5 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
General Safety and
Performance Requirements Clause(s)/sub-clause(s) of
Remarks/Notes
of Regulation (EU) this EN
2017/745
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Aspects of manufacture other
than those related to maintenance of
sterility during aseptic processing are not
covered.
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International Title Corresponding European
Clause 2 Standard Edition Standard Edition
ISO 13408-2 ISO 13408-2:2018 Aseptic processing of health care EN ISO 13408-2:2018
products — Part 2: Sterilizing
filtration
ISO 13408-6 ISO 13408-6:2021 Aseptic processing of health care EN ISO 13408-6:2021
products — Part 6: Isolator
systems
ISO 14644- ISO 14644-1:2015 Cleanrooms and associated EN ISO 14644-1:2015
1:2015 controlled environments —
Part 1: Classification of air
cleanliness by particle
concentration
ISO 14644-2 ISO 14644-2:2015 Cleanrooms and associated EN ISO 14644-2:2015
controlled environments —
Part 2: Monitoring to provide
evidence of cleanroom
performance related to air
cleanliness by particle
concentration
ISO 14664-4 ISO 14664-4:2001 Cleanrooms and associated EN ISO 14664-4:2001
controlled environments —
Part 4: Design, construction and
start-up
ISO 14644-7 ISO 14644-7:2004 Cleanrooms and associated EN ISO 14644-7:2004
controlled environments —
Part 7: Separative devices (clean
air hoods, gloveboxes, isolators
and mini-environments)
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document and are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
Annex ZB
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/746 of 5
April 2017 concerning in vitro diagnostic medical devices [OJ L 117] and to system or process
requirements including those relating to quality management systems, risk management, post-market
surveillance systems, performance studies, clinical evidence or post-market performance follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZB.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/746, the differences shall be indicated in the Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/746, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the In vitro Diagnostic
Regulation (EU) 2017/746).
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 Regulation (EU) 2017/746. This means that risks have to be
‘reduced as far as possible’, ‘reduced to a level as low as reasonably practicable’, ‘reduced to the lowest possible
level’, ‘reduced as far as possible and appropriate’, ‘removed or reduced as far as possible’, ‘eliminated or reduced
as far as possible’, ‘prevented’ or ‘minimized’, according to the wording of the corresponding General Safety and
Performance Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZB.1, it means that it is
not addressed by this European Standard.
Table ZB.1 — Correspondence between this European standard and Annex I of
Regulation (EU) 2017/746 [OJ L 117] and to system or process requirements including those
relating to quality management systems, risk management, post-market surveillance systems,
performance studies, clinical evidence or post-market performance follow-up
General Safety and Clause(s)/sub-clause(s)
Performance Requirements of of Remarks/Notes
Regulation (EU) 2017/746 this EN
11.2 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Aspects of manufacture other
than those related to maintenance of a
specific microbial state by aseptic
processing are not covered. Transport and
storage conditions are not covered.
11.3 4,5,6,7,8,9 This standard provides general
requirements for processes, programs and
procedures for development, validation
and routine control of aseptic processing.
This General Safety and Performance
Requirement is addressed only with regard
to devices for which use of aseptic
processing is appropriate.
This General Safety and Performance
Requirement is only partly addressed in
this European Standard. Design and
packaging for maintenance of sterility are
not covered. Aspects of manufacture other
than those related to maintenance of
sterility during aseptic processing are not
covered.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 13408-1
Third edition
2023-08
Aseptic processing of health care
products —
Part 1:
General requirements
Traitement aseptique des produits de santé —
Partie 1: Exigences générales
Reference number
ISO 13408-1:2023(E)
ISO 13408-1:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
ISO 13408-1:2023(E)
Contents Page
Foreword . vi
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 8
5 Principles of aseptic processing .9
5.1 General . 9
5.2 Use of an aseptic process . 9
5.3 Core elements . 10
5.4 Aseptic processing zones . 11
5.4.1 General . 11
5.4.2 Critical processing zone . 11
5.4.3 Direct support zones . 11
5.4.4 Indirect support zones .12
6 Process design, development and risk management .12
6.1 General .12
6.2 Process design . 13
6.3 Risk assessment . 14
6.4 Identification of critical control points and process parameters . 14
6.5 Handling and processing . 15
6.6 Environment and air handling . 15
6.7 Materials . 16
6.8 Personnel . 16
6.8.1 General . 16
6.8.2 Training . 16
6.8.3 Health . 17
6.8.4 Interventions . 17
6.8.5 Service personnel . 17
6.8.6 Cleanroom clothing systems . 17
6.9 Aseptic processing equipment. 18
6.9.1 General . 18
6.9.2 Automated processes and robotics . 19
6.9.3 Single use systems and connecting devices . 19
6.9.4 Auxiliary equipment and utilities . 19
6.10 Components . 20
6.11 Product related safety requirements . 20
6.12 Aseptic final packaging process . 20
6.13 Flow management . 20
6.13.1 Containment .20
6.13.2 Cross contamination . 21
6.13.3 Item introduction . 21
6.13.4 Egress . 21
6.13.5 Waste management . . 21
6.14 Manufacturing process duration . . 22
7 Contamination control strategy (CCS) .22
7.1 General .22
7.2 Cleaning and disinfection programs . 22
7.2.1 General .22
7.2.2 Cleaning . 23
7.2.3 Disinfection . 23
7.2.4 Equipment used for cleaning and disinfection in APA . 24
iii
ISO 13408-1:2023(E)
7.2.5 Cleaning process validation . 24
7.2.6 Disinfection process validation . . 25
7.2.7 Cleaning and disinfection of equipment . 25
7.2.8 Cleaning and disinfection procedures . 25
7.3 Sterilization . 26
7.3.1 General . 26
7.3.2 Sterilization processes . 26
7.3.3 Sterilization equipment . 26
7.3.4 Sterilization procedures . 26
7.3.5 Post aseptic lethal treatments . 27
7.3.6 Endotoxin control . 27
7.3.7 Depyrogenation process . 27
7.4 Maintenance of sterility .28
7.5 Maintenance and calibration programs .30
7.5.1 Service personnel . 30
7.5.2 Planned maintenance activities .30
7.5.3 Unplanned maintenance . 31
7.5.4 Calibration of equipment . 31
7.6 Environmental monitoring . 31
7.6.1 General . 31
7.6.2 Sampling for non-viable particulate monitoring . 32
7.6.3 Sampling for microbiological environmental monitoring . 32
7.7 Containment of highly potent or toxic substances . 33
8 Demonstration of the effectiveness .33
8.1 Equipment qualification and validation. 33
8.1.1 General . 33
8.1.2 User requirements specification . 33
8.1.3 Design qualification .34
8.1.4 Installation qualification (IQ).34
8.1.5 Operational qualification (OQ) .34
8.1.6 Performance qualification (PQ) .34
8.1.7 Requalification .34
8.2 Aseptic process validation . 35
8.2.1 General . 35
8.2.2 Establishment and management of interventions. 35
8.2.3 Process simulation. 35
8.2.4 Initial aseptic qualification .38
8.2.5 Periodic performance requalification .38
8.2.6 Repeat of initial aseptic qualification .39
8.2.7 Documentation of process simulations .39
8.2.8 Disposition of filled product .40
8.2.9 Aseptic process lifecycle considerations .40
8.3 Maintenance of process . 41
8.3.1 General . 41
8.3.2 Review of the manufacturing process . 41
8.3.3 Changes or developments to the manufacturing process . 41
9 Product release .42
9.1 General . 42
9.2 Testing for sterility . 42
9.3 Testing for bacterial endotoxins . 42
9.4 Testing for mycoplasma . . 43
9.5 Rapid and alternative microbiological methods . 43
Annex A (informative) Aseptic processing — Typical elements . 44
Annex B (informative) Risk management .45
Annex C (informative) Typical processing zones .52
iv
ISO 13408-1:2023(E)
Annex D (informative) Comparison of classification of cleanrooms and filters .57
Annex E (informative) Example of an aseptic process flow chart .60
Annex F (informative) Closed systems and robotics .61
Annex G (informative) Sterile cleanroom clothing system qualification .64
Annex H (informative) Rapid and alternative microbiological methods .68
Bibliography .70
v
ISO 13408-1:2023(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
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 13408-1:2008) which has been
technically revised. It also incorporates ISO 13408-1:2008/Amd 1: 2013.
The main changes are as follows:
— a complete restructuring of the document;
— inclusion of a diagram to explain the relationship between the ISO 13408 series and ISO 18362;
— revision of the normative references;
— alignment of definitions with ISO 11139:2018;
— positioning of the document to recognize current and future advances in sterile manufacturing
technology, acknowledging that new approaches to aseptic processing are transforming classical
aseptic processing;
— promotion of aseptic processing principles and the systematic implementation of quality risk
management (QRM), including for aseptic process design, and microbiological contamination and
particulate contamination control;
— provision of guidance for different types of aseptic processing, for example, manual processing
systems to automated robotic processing systems;
vi
ISO 13408-1:2023(E)
— deletion of tables from the previous edition of this document referring to acceptance criteria for
process simulation (media fill) qualification and requalification;
— encouraging adoption
...
Frequently Asked Questions
SIST EN ISO 13408-1:2024 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)". This standard covers: This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
SIST EN ISO 13408-1:2024 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 13408-1:2024 has the following relationships with other standards: It is inter standard links to SIST EN ISO 13408-1:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 13408-1:2024 is associated with the following European legislation: EU Directives/Regulations: 2017/745, 2017/746; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN ISO 13408-1:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
SIST EN ISO 13408-1:2024 표준은 의료 제품의 무균 처리에 대한 일반 요구 사항을 규정하고 있으며, 이와 관련된 프로세스, 프로그램 및 절차에 대한 지침을 제공합니다. 이 문서는 무균 처리의 전반적인 주제에 대한 요구 사항과 지침을 포함하고 있어, 의료 분야에서 매우 중요한 기준으로 자리잡고 있습니다. 이 표준의 강점은 명확하고 구체적인 요구 사항을 제시하여 의료 제품의 품질과 안전성을 보장하는 데 기여한다는 점입니다. 특히, 무균 처리 과정에서의 프로세스 개발, 검증 및 일상적인 관리를 위한 체계적인 접근 방식을 제공하여, 제조자가 안정성과 효율성을 높일 수 있도록 돕습니다. 또한, SIST EN ISO 13408-1:2024은 다양한 전문화된 프로세스와 방법에 대한 구체적인 요구 사항 및 지침을 제공하는 ISO 13408 시리즈의 다른 부분과 연결되어 있어, 전체적인 무균 처리 시스템의 이해와 적용을 한층 더 확장할 수 있습니다. 이는 CIP(제자리 세척), SIP(제자리 멸균) 기술 및 아이솔레이터 시스템 등과 관련된 최신 기술 및 방법론에 대한 인식을 제고하는 데 중요한 역할을 합니다. 결론적으로, SIST EN ISO 13408-1:2024 표준은 의료 제품의 무균 처리에 있어 필수적인 가이드라인을 제공하며, 이로 인해 효율적이고 안전한 무균 처리 환경을 구축할 수 있도록 지원하는 중요한 문서입니다. 이 표준은 현대 의료 분야에서 품질 관리와 안전 기준을 유지하는 데 필수적인 요소로 자리매김하고 있습니다.
SIST EN ISO 13408-1:2024は、医療製品の無菌処理に関する一般要件を規定している重要な文書です。この標準は、無菌処理のプロセス、プログラム、手順の開発、検証、ルーチンコントロールに関する要求事項とガイダンスを提供します。 この標準の強みは、無菌処理に関する包括的なガイドラインを提供することで、医療製品の安全性と品質を確保する手助けをしている点です。具体的には、無菌処理全般に関する要求事項が明確に示されており、関連する専門的なプロセスや手法に対する知見を得ることができます。また、ISO 13408シリーズの他の部分において、ろ過滅菌、凍結乾燥、クリーンインプレイス（CIP）技術、現場滅菌（SIP）、アイソレーターシステムに関する特定の要求事項とガイダンスも提供されており、包括的な理解を促進します。 SIST EN ISO 13408-1:2024は、無菌処理の標準化において必須のドキュメントであり、医療業界における製品の信頼性向上に寄与します。無菌処理に関する実務者や規制当局にとって、非常に有益なリソースであり、現場での実施に役立つ情報を豊富に含んでいます。この標準を基にして、さらなる無菌処理の質の向上が期待されます。
Die SIST EN ISO 13408-1:2024 ist ein entscheidendes Dokument, das allgemeine Anforderungen für die aseptische Verarbeitung von Gesundheitsprodukten festlegt. Es bietet umfassende Richtlinien zu Prozessen, Programmen und Verfahren, die für die Entwicklung, Validierung und routinemäßige Kontrolle in der aseptischen Herstellung erforderlich sind. Der Standard adressiert die generellen Anforderungen, die für die gesamte Thematik der aseptischen Verarbeitung von Bedeutung sind. Ein besonderer Stärke der SIST EN ISO 13408-1:2024 liegt in ihrer Fähigkeit, klare und strukturierte Vorgaben zu liefern, die es Herstellern ermöglichen, sicherzustellen, dass ihre Produkte die erforderlichen Qualitätsstandards erfüllen. Der Standard betont die Wichtigkeit von validierten Prozessen und regt zur Implementierung von Best Practices im Bereich der aseptischen Verfahren an. Die angebotenen Leitlinien sind nicht nur umfassend, sondern auch praxisnah, um den Herstellern eine effektive Umsetzung zu ermöglichen. Ein weiterer relevanter Aspekt dieser Norm ist die enge Verknüpfung zu den spezifischen Anforderungen und Techniken, die in den weiteren Teilen der ISO 13408 Reihe behandelt werden. Dazu zählen Methoden zur Sterilisierung durch Filtration, Lyophilisation, Clean-in-Place (CIP)-Technologien, Sterilisation vor Ort (SIP) sowie Isolatorsysteme. Durch diese klare Strukturierung in verschiedene Teile ermöglicht der Standard eine vertiefte Auseinandersetzung mit spezialisierten Prozessen und Methoden, was die Anwendung in der Praxis zusätzlich erleichtert. Die Relevanz der SIST EN ISO 13408-1:2024 wird durch den kontinuierlichen Bedarf an hohen Sicherheits- und Qualitätsstandards im Gesundheitswesen unterstrichen. In einer Branche, in der die Qualität der Produkte direkt die Gesundheit der Patienten beeinflusst, ist dieser Standard von zentraler Bedeutung für die Gewährleistung sicherer und effektiver aseptischer Prozesse. Die Einhaltung dieser Vorgaben unterstützt nicht nur die Produktintegrität, sondern auch das Vertrauen der Verbraucher in die Gesundheitsprodukte, die auf dem Markt angeboten werden.
The SIST EN ISO 13408-1:2024 standard provides a comprehensive framework for the aseptic processing of health care products, encompassing crucial general requirements that ensure the safety and efficacy of these products. Its primary focus is on the development, validation, and routine control processes critical to maintaining aseptic conditions throughout production. One of the notable strengths of this standard is its thorough guidance on various programs and procedures necessary for effective aseptic processing. This guidance aids manufacturers in aligning their processes with internationally recognized best practices, enhancing product quality and compliance. The document's emphasis on routine control adds an additional layer of assurance, establishing a systematic approach to monitoring aseptic environments. Furthermore, the scope of SIST EN ISO 13408-1:2024 reflects its relevance in today's health care landscape, where the integrity of aseptic processing is paramount. By addressing overall requirements and providing foundational knowledge, it serves as an essential resource for organizations involved in the development and production of health care products. The standard also lays the groundwork for further specialization in aseptic processing through its relationship with other parts of the ISO 13408 series. This interconnectedness allows professionals to dive deeper into specific topics such as sterilizing filtration, lyophilization, and clean-in-place (CIP) technologies, ensuring a holistic understanding of aseptic processing methods. In summary, the SIST EN ISO 13408-1:2024 standard is pivotal in guiding health care product manufacturers in establishing robust aseptic processing systems. Its structured approach to general requirements and its ability to connect with additional ISO 13408 documents make it a critical reference for ensuring industry compliance and product safety.
La norme SIST EN ISO 13408-1:2024, intitulée "Aseptic processing of health care products - Part 1: General requirements", constitue un cadre essentiel pour l'industrie des produits de santé. Ce document précise les exigences générales et fournit des orientations sur les processus, programmes et procédures dédiés au développement, à la validation et au contrôle courant des procédés de stérilisation aseptique. L'étendue de cette norme est particulièrement large, couvrant les exigences fondamentales nécessaires pour garantir la sécurité et l'efficacité des produits de santé traités de manière aseptique. Ce guide englobe des éléments cruciaux qui touchent à l'ensemble du processus de traitement aseptique, ce qui le rend d’une grande pertinence pour les professionnels du secteur. Parmi ses points forts, la norme met en avant des exigences explicites qui aident à standardiser les pratiques au sein des établissements de santé, tout en minimisant les risques de contamination. L'orientation qu'elle offre sur le développement et la validation contribue à renforcer la confiance des consommateurs et des professionnels de santé dans les produits qu'ils utilisent. De plus, bien que la norme SIST EN ISO 13408-1:2024 aborde les exigences générales, d'autres parties de la série ISO 13408 approfondissent des processus spécialisés tels que la filtration stérilisante et la lyophilisation, offrant ainsi une couverture complète des méthodes et technologies disponibles. En conclusion, la pertinence de cette norme pour le secteur des soins de santé est indéniable, étant donnée sa capacité à établir des bases solides pour un traitement aseptique efficace, et son rôle dans la garantie de procédures conformes aux meilleures pratiques industrielles.
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