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.
Frequently Asked Questions
EN ISO 13408-1:2024 is a standard published by the European Committee for Standardization (CEN). 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.
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.
EN ISO 13408-1:2024 has the following relationships with other standards: It is inter standard links to EN ISO 13408-1:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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 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 CEN standards.
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
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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
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.
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
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
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
...
The EN ISO 13408-1:2024 standard outlines the general requirements for aseptic processing of health care products, offering essential guidance on developing, validating, and routine controlling of these processes. Its comprehensive scope ensures that stakeholders have a clear framework for implementing effective aseptic techniques, which is critical for maintaining product integrity and patient safety. One of the strengths of EN ISO 13408-1:2024 is its thorough approach to establishing requirements that govern quality management in aseptic processing. The standard emphasizes the importance of validated processes, which are crucial for ensuring that health care products are free from contamination. Moreover, by addressing the development and validation phases, the standard assists organizations in building a robust quality assurance system tailored to the unique challenges of aseptic manufacturing. Relevance in today's health care landscape cannot be overstated. As the demand for safe, sterile products continues to rise, EN ISO 13408-1:2024 serves as a pivotal reference for manufacturers, regulators, and quality professionals. This standard aligns with global safety and quality objectives, thereby enhancing trust among consumers and healthcare providers alike. Its focus on aseptic processing is particularly salient, given the ongoing advancements in biopharmaceuticals and the increasing complexity of health care products. Furthermore, while EN ISO 13408-1:2024 provides general requirements, it acts as a foundational guideline that complements the other parts of the ISO 13408 series. By collaborating with those specific documents that delve into specialized processes-including sterilizing filtration and isolator systems-this standard ensures a holistic understanding of aseptic processing, enabling professionals to adopt best practices across varied applications. In summary, EN ISO 13408-1:2024 delivers vital requirements and guidance for effective aseptic processing, reflecting current industry needs and regulatory expectations while reinforcing the integral role of stringent quality controls in health care product safety.
EN ISO 13408-1:2024 표준 문서는 의료 제품의 무균 가공에 대한 일반 요구 사항을 명확히 하며, 무균 처리의 개발, 검증 및 일상 운영 관리를 위한 프로세스, 프로그램 및 절차에 대한 지침을 제공합니다. 이 표준은 무균 가공의 전반적인 주제를 다루며, 의료 분야에서의 안전성과 효율성을 위한 기초적 바탕을 제공합니다. 이 표준의 강점 중 하나는 다양한 전문 프로세스 및 방법에 대한 요구 사항과 지침을 포괄적으로 제공한다는 점입니다. 특히, 멸균 필터링, 동결 건조, 제자리 청소(CIP) 기술, 제자리 멸균(SIP), 그리고 아이솔레이터 시스템과 같은 무균 가공의 프레임워크를 체계적으로 정리하고 있어, 관련 분야의 실무자들에게 실질적인 도움이 될 만한 내용을 포함하고 있습니다. 또한, ISO 13408 시리즈의 다른 부분들과의 연계를 통해, 특정 분야의 무균 처리 방법에 대한 깊이 있는 이해를 가능하게 하여, 의료 제품의 안전성과 효능을 보장합니다. 이러한 점에서 EN ISO 13408-1:2024 표준은 의료 산업에서 무균 처리의 중요성을 강조하며, 품질 관리 및 안전성 확보를 위한 필수적인 기준으로 자리 잡고 있습니다. 결론적으로, 이 표준은 무균 가공의 전반적인 요구 사항을 충족할 뿐만 아니라, 실무에 있어 매우 유용한 지침을 제공하여 의료 제품의 품질을 높이는 데 크게 기여할 것입니다.
Le document SIST EN ISO 13408-1:2024, qui porte sur l'aseptisation des produits de santé, établit des exigences générales et fournit des orientations essentielles pour le développement, la validation et le contrôle routinier des processus d'aseptisation. Cette norme est cruciale dans le domaine de la santé, car elle garantit que les produits médicaux sont fabriqués de manière sûre et fiable. L'étendue de cette norme englobe un large éventail de procédures et de méthodes qui se rapportent au traitement aseptique. En précisant les exigences générales, le document assure une harmonisation des pratiques au sein de l'industrie, ce qui renforce la sécurité des produits de santé pour les consommateurs. De plus, il sert de référence pour le personnel impliqué dans les processus de fabrication, lui offrant un cadre clair pour garantir la conformité et l'efficacité des opérations. Parmi les forces notables de ce standard, on peut mentionner la clarté et la structure de ses directives, ce qui facilite leur mise en œuvre par les professionnels de santé. De plus, le document met en avant l’importance de la validation des processus, ce qui est essentiel pour maintenir la qualité et l'intégrité des produits de santé tout au long de leur cycle de vie. La pertinence de la norme SIST EN ISO 13408-1:2024 dans un paysage de réglementation en constante évolution ne peut être sous-estimée. En intégrant des pratiques exemplaires et des recommandations fondées sur les dernières recherches et innovations dans le domaine de l'aseptisation, ce standard soutient les organisations dans leur quête de l'excellence opérationnelle et de la conformité réglementaire. En conclusion, cette norme est un outil indispensable pour toutes les entités qui s'engagent à garantir la sécurité et l'efficacité des produits de santé, en intégrant les exigences pertinentes pour les divers processus et methodologies liés à l'aseptisation.
Die Norm EN ISO 13408-1:2024 legt die allgemeinen Anforderungen für die aseptische Verarbeitung von Gesundheitsprodukten fest und bietet umfassende Leitlinien für die Entwicklung, Validierung und routinemäßige Kontrolle dieser Prozesse. Sie ist von großer Bedeutung für Unternehmen, die im Bereich der pharmazeutischen Produkte, Biotechnologie und Medizintechnik tätig sind, da sie essentielle Kriterien für die Gewährleistung der Sterilität und Sicherheit von Gesundheitsprodukten umfasst. Ein herausragendes Merkmal dieser Norm ist ihre umfassende Darstellung der allgemeinen Anforderungen an aseptische Verarbeitung. Sie hilft dabei, die Prozesse zu standardisieren und fördert das Verständnis für notwendige Maßnahmen zur Risikominderung bei der Herstellung aseptisch verarbeiteter Produkte. Die Norm bietet nicht nur grundlegende Anforderungen, sondern auch wertvolle Hinweise, die eine effektive Implementierung und Kontrolle der Prozesse unterstützen. Die Relevanz der EN ISO 13408-1:2024 zeigt sich insbesondere in ihrer Fähigkeit, Unternehmen anzuleiten, Compliance mit internationalen Standards zu erreichen und gleichzeitig die Qualität ihrer Produkte zu sichern. Durch die spezifischen Anforderungen und Leitlinien zur Entwicklung und Validierung von aseptischen Prozessen können Herstellungsfehler und Kontaminationen minimiert werden. Zudem ist die Norm Teil einer umfassenderen Normenreihe, die sich mit speziellen Verfahren und Methoden befasst, wie Sterilfiltration, Lyophilisation, Reinigung vor Ort (CIP) und Sterilisation vor Ort (SIP). Dies gewährleistet, dass Nutzer auf spezialisierte Informationen zugreifen können, die auf ihre konkreten Anforderungen in Bezug auf aseptische Prozesse zugeschnitten sind. Insgesamt bietet die EN ISO 13408-1:2024 eine solide Grundlage für die Umsetzung sicherer aseptischer Verfahren im Gesundheitssektor und spielt eine entscheidende Rolle bei der Sicherstellung der Qualität und Sicherheit von Gesundheitsprodukten. Die Norm fördert nicht nur das technische Verständnis, sondern auch die Einhaltung regulatorischer Anforderungen, wodurch sie sich als unverzichtbares Dokument für Fachleute in der Branche etabliert.
SIST EN ISO 13408-1:2024は、医療製品の無菌処理に関する一般的な要件を規定し、開発、バリデーション、日常的な管理に関するプロセス、プログラム、および手順についてのガイダンスを提供する重要な文書です。この標準は、無菌処理の全体的なトピックに関連する要件とガイダンスを含んでおり、医療製品の品質と安全性を確保するための基盤を提供します。 この標準の強みは、無菌処理に関する一般的な要件に加え、実際の運用に役立つ具体的な指針が含まれている点です。特に、無菌処理を効果的に管理するための明確なフレームワークを提供し、業界全体のベストプラクティスに整合することが求められます。これにより、製造プロセスの均一性と信頼性が向上し、製品の無菌性を保証することができます。 さらに、ISO 13408シリーズの他の部分では、滅菌フィルタリング、凍結乾燥、クリーンインプレイス（CIP）技術、設置滅菌（SIP）およびアイソレータシステムなど、専門的なプロセスや方法に関する具体的な要件とガイダンスが提供されており、これらのセクションと組み合わせることで、包括的な無菌処理のガイドラインが形成されています。 このように、SIST EN ISO 13408-1:2024は、医療製品の無菌処理における基準を確立し、高品質な製品の提供を支えるために極めて重要な役割を果たしています。無菌性がさらに重要視される現代の医療環境において、この標準はその関連性と必要性をますます高めています。
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