kSIST FprEN ISO 13408-1:2023
(Main)Aseptic processing of health care products - Part 1: General requirements (ISO/FDIS 13408-1:2023)
Aseptic processing of health care products - Part 1: General requirements (ISO/FDIS 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/FDIS 13408-1:2023)
Der vorliegende Teil von ISO 13408 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.
Der vorliegende Teil von ISO 13408 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 anderen Teilen von ISO 13408 angeführt.
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO/FDIS 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/FDIS 13408-1:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 13408-1:2022
01-februar-2022
Aseptična proizvodnja izdelkov za zdravstveno nego - 1. del: Splošne zahteve
(ISO/DIS 13408-1:2021)
Aseptic processing of health care products - Part 1: General requirements (ISO/DIS
13408-1:2021)
Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine
Anforderungen (ISO/DIS 13408-1:2021)
Traitement aseptique des produits de santé - Partie 1 : Exigences générales (ISO/DIS
13408-1:2021)
Ta slovenski standard je istoveten z: prEN ISO 13408-1
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 13408-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 13408-1:2022
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oSIST prEN ISO 13408-1:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13408-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-12-16 2022-03-10
Aseptic processing of health care products —
Part 1:
General requirements
Traitement aseptique des produits de santé —
Partie 1: Exigences générales
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
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WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 13408-1:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2021
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oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(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 .8
5.1 General . 8
5.2 Use of an aseptic process . 9
5.3 Core elements . 10
5.4 Aseptic processing zones . 10
5.4.1 General . 10
5.4.2 Critical processing zone . 11
5.4.3 Direct support zones . 11
5.4.4 Indirect support zones . 11
6 Risk based process design, development and risk management .11
6.1 General . 11
6.2 Process design . 13
6.3 Risk assessment . 13
6.4 Identification of critical control points and process parameters . 14
6.5 Handling and processing . 14
6.6 Environment and air handling . 14
6.7 Materials . 15
6.8 Personnel . 15
6.8.1 General .15
6.8.2 Training . 16
6.8.3 Cleanroom clothing systems . 16
6.8.4 Health . 17
6.8.5 Service personnel . 17
6.9 Aseptic processing equipment. 18
6.9.1 General . 18
6.9.2 Automated processes and robotics . 18
6.9.3 Single use systems and connecting devices . 18
6.9.4 Auxiliary equipment and utilities . 18
6.10 Components . 19
6.10.1 General . 19
6.10.2 Integrity test . 19
6.11 Product . 19
6.11.1 Containment . 19
6.11.2 Aseptic Final Packaging Process . 19
6.12 Flow management . 20
6.12.1 Containment .20
6.12.2 Cross contamination . 20
6.12.3 Item introduction . . 20
6.12.4 Egress . 21
6.12.5 Waste management . 21
6.13 Manufacturing process duration . . 21
7 Contamination control strategy .21
7.1 General . 21
7.2 Cleaning and disinfection programs . 22
7.2.1 General .22
7.2.2 Cleaning . 22
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7.2.3 Disinfection . 23
7.2.4 Equipment used for cleaning and disinfection in APA .23
7.2.5 Cleaning process validation . 24
7.2.6 Disinfection process validation . 24
7.2.7 Cleaning and disinfection of equipment . 24
7.2.8 Cleaning and disinfection procedures . 25
7.3 Sterilization . 25
7.3.1 General . 25
7.3.2 Sterilization processes .25
7.3.3 Sterilization equipment . 25
7.3.4 Sterilization procedures . 26
7.3.5 Endotoxin control .26
7.3.6 Depyrogenation process . 26
7.3.7 Maintenance of sterility . 27
7.4 Maintenance and calibration programs .29
7.4.1 Service personnel .29
7.4.2 Planned maintenance activities .29
7.4.3 Unplanned maintenance . 30
7.4.4 Calibration of equipment . 30
7.5 Environmental monitoring . 30
7.5.1 General .30
7.5.2 Sampling for non-viable particulate monitoring . 31
7.5.3 Sampling for microbiological environmental monitoring . 31
7.6 Containment of potent or toxic substances. 32
8 Demonstration of the effectiveness .32
8.1 Equipment qualification and validation. 32
8.1.1 General . 32
8.1.2 User requirements specification . 32
8.1.3 Design qualification . 33
8.1.4 Installation qualification . 33
8.1.5 Operational qualification . 33
8.1.6 Performance qualification . 33
8.1.7 Requalification .34
8.2 Aseptic process validation .34
8.2.1 General .34
8.2.2 Establishment and management of interventions.34
8.2.3 Process simulation.34
8.2.4 Initial aseptic qualification . 37
8.2.5 Periodic performance requalification . 37
8.2.6 Repeat of initial aseptic qualification .38
8.2.7 Documentation of process simulations .39
8.2.8 Disposition of filled product . 39
8.2.9 Aseptic process lifecycle considerations .40
8.3 Maintenance of process .40
8.3.1 General .40
8.3.2 R eview of the manufacturing process .40
8.3.3 Changes or developments to the manufacturing process . 41
8.3.4 R eview the risk assessment. 41
9 Product release .41
9.1 General . 41
9.2 Testing for sterility . 41
9.3 Testing for bacterial endotoxins . 42
9.4 Rapid and alternative microbiological methods . 42
Annex A (informative) Aseptic processing – typical elements .43
Annex B (informative) Specific risks to consider . 44
Annex C (informative) Typical processing zones .50
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Annex D (informative) Comparison of classification of cleanrooms and filters .55
Annex E (informative) Example of an aseptic process flow chart .57
Annex F (informative) Closed systems and robotics .58
Annex G (informative) Sterile cleanroom clothing system qualifications .61
Annex H (informative) Rapid and alternative microbiological methods .65
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be
covered .67
Annex ZB (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered .70
Bibliography .72
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oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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.
This third edition cancels and replaces the second edition (ISO 13408-1:2008) which has been
technically revised.
The main changes compared to the previous edition 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 through to automated robotic processing systems;
— deletion of tables from the previous edition of this document referring to acceptance criteria for
process simulation (media fill) qualification and requalification;
— encouraging adoption of advanced aseptic processing technologies and continuous process
improvement to improve assurance of sterility;
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oSIST prEN ISO 13408-1:2022
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— recognition that alternative or rapid microbiological methods provide timely microbiological data
vital for process monitoring and control, and for product release; and
inclusion of a series of informative annexes providing guidance on defining an aseptic process, including
risks to be considered, aseptic processing areas, classification of cleanrooms, aseptic process flow,
closed systems and robotics, and qualification of a cleanroom clothing system.
A list of all parts in the ISO 13408 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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oSIST prEN ISO 13408-1:2022
ISO/DIS 13408-1:2021(E)
Introduction
Wherever possible, healthcare products intended to be sterile should be terminally sterilized in their
final sealed container. Where a health care product is intended to be sterile and cannot withstand
terminal sterilization in its final container, aseptic processing provides an acceptable alternative for
product manufacture. Fundamentally, aseptic processing minimises the probability of a chance event of
microbial contamination occurring. The rationale to use aseptic processing is product dependent and is
not based solely on manufacturing considerations.
Aseptic processing produces a sterile product in its final container by the assembly of component parts
(e.g. product, container and container closure) that have been sterilized separately by validated and
controlled processes suitable for each component part. Each of these assembly processes can introduce
error that could result in produ
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