EN ISO 13408-2-2018 Aseptic processing of health care products - Part 2 Sterilizing filtration.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Aseptic processing of health care productsPart 2: Sterilizing filtrationBS EN ISO 134082:2018National forewordThis British Standard is the UK implementation of EN ISO 134082:2018. It is identical to ISO 134082:2018. It

2、supersedes BS EN ISO 134082:2011, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on this committee can be obtained on request to its secretary.This public

3、ation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 86866 5ICS 11.080.01Compliance with a British Standard cannot confer immunity

4、from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 134082:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 13

5、4082March 2018ICS 11.080.01 Supersedes EN ISO 134082:2011EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCENCENELEC Management Centre: Avenue Marnix 17, B1000 Brussels 2018 CEN Ref. No. EN ISO 134082:2018: EAll rights of exploitation in any form and

6、by any means reserved worldwide for CEN national MembersAseptic processing of health care products Part 2: Sterilizing filtration (ISO 134082:2018)Traitement aseptique des produits de sant Partie 2: Filtration strilisante (ISO 134082:2018)Aseptische Herstellung von Produkten fr die Gesundheitsfrsorg

7、e Teil 2: Sterilfiltration (ISO 134082:2018)This European Standard was approved by CEN on 2 January 2018.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

8、. Uptodate lists and bibliographical references concerning such national standards may be obtained on application to the CENCENELEC 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 trans

9、lation under the responsibility of a CEN member into its own language and notified to the CENCENELEC 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,

10、 Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 134082:2018

11、 (E)European forewordThis document (EN ISO 134082:2018) 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 s

12、hall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2018, and conflicting national standards shall be withdrawn at the latest by September 2018.Attention is drawn to the possibility that some of the elements of thi

13、s 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 134082:2011.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and

14、 supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA, B, and C, which are an integral part of this document.The following referenced documents are indispensable for the application of this document. For undated references, the edition of

15、 the referenced document (including any amendments) listed below applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annexes ZA, ZB or ZC, the user should always check that any referenced document has not been superseded and that

16、 its relevant contents can still be considered the generally acknowledged stateofart. When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO

17、or IEC standard as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.Table Correlation between normative references and dated EN and ISO standardsNormative references as listed in Clause

18、2 of the ISO standardEquivalent dated standardEN ISOISO 134081:2008 + Amd 1:2013 EN ISO 134081:2015 ISO 134081:2008 + Amd 1:2013 ISO 134085 EN ISO 134085:2011 ISO 134085:2006 ISO 11135 EN ISO 11135:2014 ISO 11135:2014 ISO 111371 EN ISO 111371:2015 ISO 111371:2006 + Amd 1:2013 ISO/DIS 11139:2017 prEN

19、 ISO 11139:2017 ISO/DIS 11139:2017 ISO 13485 EN ISO 13485:2016 + AC:2016 ISO 13485:2016 ISO 176651 EN ISO 176651:2006 ISO 176651:2006 According to the CENCENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austr

20、ia, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain

21、, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 134082:2018 has been approved by CEN as EN ISO 134082:2018 without any modification.2BS EN ISO 134082:2018ISO 134082:2018Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Qua

22、lity system elements 34.1 General . 34.2 Management responsibility . 34.3 Procurement of filters . 35 Sterilizing filter characterization 35.1 General . 35.2 Microbial removal effectiveness. 45.3 Material effects 45.4 Environmental considerations 56 Process and equipment characterization . 56.1 Gene

23、ral . 56.2 Risk management . 56.3 Process characterization 66.4 Equipment characterization 67 Fluid definition . 77.1 General . 77.2 Microbiological quality 88 Process definition 88.1 General . 88.2 Filter definition and characterization . 98.2.1 General 98.2.2 Compatibility between the filter and f

24、luid 98.2.3 Filter use 108.3 Filtration process definition . 108.4 Integrity testing process definition 119 Validation 129.1 General 129.2 Validation of fluidspecific microbial retention by sterilizing filters for liquids .129.2.1 General. 129.2.2 Test organism 139.3 Validation of the integrity test

25、 for sterilizing filters for liquids .149.4 Validation of filter interactions with the process fluid 159.5 Validation of the sterilization of filter system .159.6 Validation of fluidspecific microbial retention by sterilizing filters for gases .159.6.1 General.159.6.2 Aerosol retention 159.6.3 Valid

26、ation of physical integrity testing 159.6.4 Compatibility and service life 169.6.5 Validation of the sterilization of the filter system for gases 1610 Routine monitoring and control .1611 Product release from sterilizing filtration .1612 Maintaining process effectiveness 1712.1 General 1712.2 Recali

27、bration 17 ISO 2018 All rights reserved iiiContents PageBS EN ISO 134082:2018ISO 134082:201812.3 Maintenance of equipment 1712.4 Requalification .1712.5 Assessment of change 18Annex A (informative) Guidance on the application of this document 19Bibliography .34iv ISO 2018 All rights reservedBS EN IS

28、O 134082:2018ISO 134082:2018ForewordISO (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

29、 in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commi

30、ssion (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 s

31、hould 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

32、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 con

33、venience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the T

34、echnical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.This second edition cancels and replaces the first edition (ISO 134082:2003), which has been technically revised.A

35、 list of all parts in the ISO 13408 series can be found on the ISO website. ISO 2018 All rights reserved vBS EN ISO 134082:2018ISO 134082:2018IntroductionISO 134081 covers general aspects of aseptic processing. Several processes including sterilizing filtration, lyophilization, clean and sterilizati

36、on in place, isolator systems, and alternative processes for medical devices and combination products were found to be in need of supplementary information, which was too extensive to be included in the corresponding annexes to ISO 134081. This information is presented in ISO 134082 to ISO 134087.St

37、erilizing filtration is a critical step in an aseptic manufacturing process. Validation of sterilizing filtration processes can be complex and is generally conducted in both a process and product specific manner. This document describes requirements that, if met, will provide a sterilizing filtratio

38、n process that consistently removes microorganisms from a fluid (liquid or gas) without negatively affecting the quality of the filtrate. Furthermore, conformity with the requirements ensures that a sterilizing filtration process is both reliable and reproducible so that a determination can be made,

39、 with reasonable confidence, that the sterilizing grade filter/s will provide a sterile filtrate under specified operational conditions. This (the reliability and reproducibility of the filtration process) is essential, as unlike a microbiocidal sterilization process where process variables can be m

40、onitored continuously, microbial retention and physical integrity of a sterilising grade filter cannot be monitored on a continuous basis throughout a filtration process.Where validation establishes a reproducible relationship between the productspecific bacterial retention capability of a sterilizi

41、ng grade filter and the physical integrity of that filter, then suitable nondestructive preuse and postuse filter integrity tests are used to determine whether a fullscale sterilizing filtration process has been conducted successfully. During terminal sterilization the kinetics of inactivation follo

42、ws a mathematical order and allow calculation of a sterility assurance level (SAL). Removal of organisms from a fluid by filtration does not follow such mathematical order and so the use of the term “sterility assurance level” is not appropriate for product sterilized by filtration.There has been a

43、significant increase in the development and availability of biopharmaceuticals, biologicbased medical devices and cellbased health care products since publication of the initial 2003 edition of this document. This second edition emphasizes the importance of a thorough understanding of the nature of

44、the indigenous bioburden of a fluid that is to be sterilized by filtration, including its relationship to the test microorganism used to determine microbial retention capability of the sterilizing grade filter. For example, Mycoplasma can cause serious contamination problems during the manufacturing

45、 of biopharmaceutical, biotechnological and cellbased health care products. A thorough understanding of the indigenous bioburden enables suitable safeguards to be implemented during development, validation and control of a sterilizing filtration process to ensure the safety and quality of the filter

46、ed fluid.While the activities required by this document have been grouped together and are presented in a particular order, this document does not require that the activities be performed in the order that they are presented. The activities required are not necessarily sequential, as the programme o

47、f development and validation may be iterative. It is possible that performing these different activities will involve a number of separate individuals and/or organizations, each of whom undertake one or more of these activities. This document does not specify the particular individuals or organizati

48、ons to carry out the activities.Guidance on the application of this document is given in Annex A.vi ISO 2018 All rights reservedBS EN ISO 134082:2018Aseptic processing of health care products Part 2: Sterilizing filtration1 ScopeThis document specifies requirements for sterilizing filtration as part

49、 of aseptic processing of health care products conducted in accordance with ISO 134081. It also offers guidance to filter users concerning general requirements for setup, validation and routine operation of a sterilizing filtration process.This document is not applicable to removal of viruses.Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial wholecell vaccines).This document is not applicable to hig