1、BSI Standards PublicationBS ISO 18362:2016Manufacture of cell-basedhealth care products Controlof microbial risks duringprocessingBS ISO 18362:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18362:2016.The UK participation in its preparation was entrusted
2、to TechnicalCommittee CH/198, Sterilization and Associated Equipment andProcesses.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its cor
3、rectapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 79537 4ICS 11.080.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strateg
4、y Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18362:2016 ISO 2016Manufacture of cell-based health care products Control of microbial risks during processingManufacture de produits de soins de sant fonds sur les cellules Contrle des ri
5、sques microbiaux durant le processusINTERNATIONAL STANDARDISO18362First edition2016-02-01Reference numberISO 18362:2016(E)BS ISO 18362:2016ISO 18362:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, n
6、o 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 or ISOs memb
7、er body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18362:2016ISO 18362:2016(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and defi
8、nitions . 24 Quality system elements 55 Process definition 55.1 General . 55.2 Risk management . 65.2.1 General considerations . 65.2.2 Cell-based starting material risk assessment . 75.2.3 CBHP process risk assessment 75.2.4 Use of risk assessment methods and tools for supply of CBHPs for use in cl
9、inical trials . 86 Manufacturing environment 86.1 General . 86.2 Alternative processes 86.3 Manufacturing environment design . 86.3.1 Containment area 86.3.2 Construction containment features . 86.4 Layout . 96.5 Material and personnel flow . 96.5.1 General 96.5.2 Equipment . 96.5.3 Handling of wast
10、e material . 96.6 HVAC system 106.7 Utility services and ancillary equipment . 106.8 Environmental and personnel monitoring programmes 107 Equipment 107.1 General 107.2 Additional requirements . 108 Personnel 118.1 General 118.2 Personnel procedures 118.3 Gowning procedures . 118.4 General employee
11、health . 119 Manufacture of product 129.1 General 129.2 Control of starting material 129.2.1 Cell-based starting material 129.2.2 Other starting materials . 129.3 Manufacturing procedures 139.4 In-process controls and process monitoring . 139.5 Virus elimination and inactivation . 1310 Process simul
12、ation and process confirmation .1310.1 General 1310.2 Process simulation 1410.3 Process confirmation studies 1410.4 Media selection and growth support 1411 Finished product release: test for sterility .15 ISO 2016 All rights reserved iiiContents PageBS ISO 18362:2016ISO 18362:2016(E)11.1 General 151
13、1.2 Additional requirements . 1512 Finished product release: testing for biological contamination that cannot be detected by the test for sterility .1612.1 General 1612.2 Extrinsic biological contamination . 1612.3 Intrinsic biological contamination 16Annex A (informative) Examples of microbial risk
14、s for CBHP 17Annex B (normative) Decision trees for application of risk assessment for cell-based starting materials .18Annex C (informative) Containment facilities 20Annex D (normative) CBHP starting material 27Annex E (normative) Containment requirements for procured, non-sterile starting material
15、s before entering the manufacturing area.29Annex F (informative) Typical elements of a process definition 30Bibliography .31iv ISO 2016 All rights reservedBS ISO 18362:2016ISO 18362:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standard
16、s 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 organiz
17、ations, 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 fur
18、ther 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/directi
19、ves).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 In
20、troduction 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 on the meaning of ISO specific terms and expressions related to
21、 conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 198, Sterilization of health care products. ISO 2016 All
22、 rights reserved vBS ISO 18362:2016ISO 18362:2016(E)Introduction0.1 GeneralA cell-based health care product (CBHP) comprises prokaryotic or eukaryotic cells or cell derived biological entities as an essential ingredient. Cell-based or cell derived starting material used in the manufacture of a CBHP
23、can be viable or non-viable and of human, animal, microbial or plant origin. A common feature of CBHPs is that their efficacy is based on their biological properties. They are classified as medicines, medical devices, biologics or combination products depending on the international, national and/or
24、regional regulations that govern supply of these products.CBHPs might be limited in their ability to withstand sterilization and purification methods. This International Standard focuses on process rather than product. It describes the minimum elements necessary for a risk-based approach to the proc
25、essing of a CBHP in order to reduce the potential for an increase in intrinsic contamination of product and to avoid extrinsic contamination of product. The design of the processes, equipment, facilities, utilities, the conditions of preparation and addition of buffers and reagents, and training of
26、the operators are key considerations to minimize contamination.0.2 CBHPs labelled as sterileA CBHP that is labelled as sterile is sterilized by a terminal sterilization process or is aseptically processed.Examples of CBHPs that are terminally sterilized include, but are not restricted to, cancellous
27、 bone, demineralized bone matrix, catgut sutures, biological heart valves and tissue patches. Sterility assurance for these CBHPs is achieved through suitable design and control of the environment, controls on starting materials and packaging, suitable design and qualification of manufacturing proce
28、sses including the terminal sterilization process, and the application of appropriate in-process controls and testing. Requirements and guidance for terminal sterilization of CBHPs are contained in ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11135, ISO 14160, ISO 20857, I
29、SO 14937 and ISO 25424, as applicable.Controls for some infectious agents, e.g. viruses and protozoa, might require a multifaceted approach to ensure product quality and safety. Such agents are not specifically considered in the existing standards for terminal sterilization or aseptic processing.A C
30、BHP that is labelled sterile and which cannot be terminally sterilized is aseptically processed. Sterility assurance for these CBHPs is achieved through suitable design and control of the environment, controls on starting materials and packaging, suitable design and qualification of manufacturing pr
31、ocesses, process simulation (in accordance with the requirements of the ISO 13408-series), the application of appropriate in-process controls during manufacture, and testing to demonstrate achievement of aseptic processing conditions. As a prerequisite, starting materials and packaging materials are
32、 sterilized by validated processes. In this regard this International Standard does not reiterate requirements for specific processes that are used during processing of a CBHP that is labelled sterile. In cases where a CBHP is aseptically processed and labelled as sterile refer to the ISO 13408-seri
33、es.0.3 CBHPs supplied without a label claim for sterilityFor a CBHP that is supplied without a label claim for sterility, e.g. corneal tissue or viable skin grafts, processing involves the use of appropriate aseptic techniques at all stages during the process. Components might be subject to bioburde
34、n reduction during preparation prior to their assembly or combining to form finished product. This is necessary to minimize the potential for intrinsic contamination of product to increase during processing and to avoid extrinsic contamination of product. The controls and techniques to maintain prod
35、uct quality during processing of these CBHPs might be different from those used for processing of a CBHP that is labelled sterile.Controls for some infectious agents, e.g. viruses and protozoa, can require a multifaceted approach to ensure product quality and safety.vi ISO 2016 All rights reservedBS
36、 ISO 18362:2016ISO 18362:2016(E)Microbiological quality assurance for a CBHP that is supplied without a label claim for sterility is achieved through control of the environment, controls on starting materials and packaging, suitable design and qualification of manufacturing processes, process confir
37、mation and process simulation studies and the application of appropriate in-process controls and testing. Risk assessment underpins selection of suitable microbiological quality criteria for a CBHP that is supplied without a label claim for sterility. These criteria define the acceptability of produ
38、ct based on the absence or presence, or number of microorganisms, per defined quantity of product, to ensure finished product does not pose a microbiological risk to the patient. ISO 2016 All rights reserved viiBS ISO 18362:2016BS ISO 18362:2016Manufacture of cell-based health care products Control
39、of microbial risks during processing1 ScopeThis International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is appli
40、cable both to CBHPs labelled sterile and to CBHPs not labelled sterile.This International Standard is not applicable to: procurement and transport of cell-based starting material used in processing of a CBHP, cell banking, control of genetic material, control of non-microbial product contamination,
41、in vitro diagnostics (IVDs), or natural medicines.EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.This International Standard does not define
42、biosafety containment requirements.This International Standard does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispe
43、nsable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and
44、routine control of a sterilization process for medical devicesISO 11137 (all parts), Sterilization of health-care products RadiationISO 13022:2012, Medical products containing viable human cells Application of risk management and requirements for processing practicesISO 13408-1:2008, Aseptic process
45、ing of health care products Part 1: General requirementsISO 13408-1:2008/Amd.1:2013, Aseptic processing of health care products Part 1: General requirements / Amendment 1ISO 13408-7:2012, Aseptic processing of health care products Part 7: Alternative processes for medical devices and combination pro
46、ductsISO 14160, Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesINTERNAT
47、IONAL STANDARD ISO 18362:2016(E) ISO 2016 All rights reserved 1BS ISO 18362:2016ISO 18362:2016(E)ISO 14644-4, Cleanrooms and associated controlled environments Part 4: Design, construction and start-upISO 14937, Sterilization of health care products General requirements for characterization of a ste
48、rilizing agent and the development, validation and routine control of a sterilization process for medical devicesISO 14971, Medical devices Application of risk management to medical devicesISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validat
49、ion and routine control of a sterilization process for medical devicesISO 20857, Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 22442 (all parts), Medical devices utilizing animal tissues and their derivativesISO 25424, Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for
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