EN ISO 13408-4-2011 en Aseptic processing of health care products - Part 4 Clean-inplace technologies《医疗保健产品的无菌加工 第4部分 在位清洗工艺(ISO 13408-4-2005)》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13408-4:2011Aseptic processing of health care productsPart 4: Clean-in-place technologies (ISO 13408-4:2005)BS EN ISO 13408-4:2011 BRITISH STANDARDNational forewordThis

2、 British Standard is the UK implementation of EN ISO 13408-4:2011. It is identical to ISO 13408-4:2005. Together with the other parts of the BS EN ISO 13408 series, it supersedes BS EN 13824:2004.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of me

3、dical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 72609 5 ICS 11.080.01 Co

4、mpliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 October 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE N

5、ORM EN ISO 13408-4 June 2011 ICS 11.080.01 Supersedes EN 13824:2004English Version Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) Traitement aseptique des produits de sant - Partie 4: Technologies de nettoyage sur place (ISO 13408-4:2005)Aseptisch

6、e Herstellung von Produkten fr die Gesundheitsfrsorge - Teil 4: Reinigung vor Ort (ISO 13408-4:2005) This European Standard was approved by CEN on 10 June 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard

7、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, Fr

8、ench, 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, Bulgari

9、a, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR ST

10、ANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13408-4:2011: EBS EN ISO 13408-4:2011 EN ISO

11、13408-4:2011 (E) 3 Foreword The text of ISO 13408-4:2005 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13408-4:2011 by Technical Committee CEN/TC 204 “Steriliza

12、tion 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 December 2011, and conflicting national standards shall be withdrawn at the latest

13、 by December 2011. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13824:2004. This document has been prep

14、ared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB, or ZC, which are integral parts of this document. According to the CEN/CENE

15、LEC 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, Lithuani

16、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 13408-4:2005 has been approved by CEN as a EN ISO 13408-4:2011 without any modification. BS EN ISO 13408-4:2011EN ISO 13408-

17、4:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade

18、 Association to provide a means of conforming to Essential Requirements of the New Approach Directive 90/385/EEC on active implantable medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at

19、 least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence b

20、etween this European Standard and Directive 90/385/EEC Clauses of this EN Essential Requirements (ERs) of Directive 90/385/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 7 This relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1

21、WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-4:2011 EN ISO 13408-4:2011 (E) 5 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/E

22、EC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is

23、cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of conformit

24、y with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZB.1 Correspondence between this European Standard and Directive 93/42/EEC Clauses of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4,5,6,7,8,9,10 8.3 This

25、relevant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10 8.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU

26、Directives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-4:2011EN ISO 13408-4:2011 (E) 6 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices

27、This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 98/79/EC on in vitro diagnostic medical devices. Once this standard is cit

28、ed in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of conformity w

29、ith the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZC.1 Correspondence between this European Standard and Directive 98/79/EC Clauses of this EN Essential Requirements (ERs) of Directive 98/79/EC Qualifying remarks/Notes 4,5,6,7,8,9,10 B.2.3 This rel

30、evant Essential Requirement is only partly addressed in this European Standard and only in conjunction with EN ISO 13408-1 4,5,6,7,8,9,10 B.2.4 This relevant Essential Requirement is addressed in this European standard only in conjunction with EN ISO 13408-1 WARNING Other requirements and other EU D

31、irectives may be applicable to the product(s) falling within the scope of this Standard. BS EN ISO 13408-4:2011ISO 13408-4:2005(E) ISO 2005 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Quality system elements 2 4.

32、1 General. 2 4.2 Management responsibility . 2 4.3 Design control. 2 4.4 Measuring instruments and measuring systems 2 5 Process and equipment characterization 3 5.1 General concepts 3 5.2 Effectiveness of CIP . 3 5.3 Equipment . 4 6 Cleaning agent characterization . 5 6.1 Selection of cleaning agen

33、t(s). 5 6.2 Quality of cleaning agent(s). 5 6.3 Safety and the environment. 6 7 CIP process . 6 7.1 Process parameters 6 7.2 Process control. 6 7.3 Residues of cleaning agent(s). 8 8 Validation. 8 8.1 Validation protocol . 8 8.2 Evaluation of the CIP process . 8 8.3 Design qualification 8 8.4 Instal

34、lation qualification. 8 8.5 Operational qualification 9 8.6 Performance qualification 9 8.7 Review and approval of validation 10 8.8 Requalification 10 9 Routine monitoring and control 10 9.1 CIP process control 10 9.2 Procedures 10 9.3 CIP process records. 11 9.4 Change control 11 9.5 Maintenance a

35、nd calibration . 11 10 Personnel training 11 Annex A (informative) Description of sampling methods 12 Annex B (informative) Calculation examples for acceptance criteria. 13 Bibliography . 14 BS EN ISO 13408-4:2011ISO 13408-4:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Orga

36、nization 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 establis

37、hed 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

38、. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. P

39、ublication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 pate

40、nt rights. ISO 13408-4 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 13408 consists of the following parts, under the general title Aseptic processing of health care products: Part 1: General requirements Part 2: Filtration Part 3: Lyophilization Part 4:

41、Clean-in-place technologies Part 5: Sterilization in place Part 6: Isolator systems BS EN ISO 13408-4:2011ISO 13408-4:2005(E) ISO 2005 All rights reserved vIntroduction During the process of preparing ISO 13408-1 several items, e.g. filtration, lyophilization drying and sterilization-in-place techno

42、logies, were found to be in need of supplementary information that was too voluminous to be given in corresponding annexes. This part of ISO 13408 includes requirements and guidance that are to be observed during clean-in-place processes. The purpose of this part of ISO 13408 is to achieve standardi

43、zation in the field of validation and routine control of clean-in-place processes used in the manufacture of health care products. Clean-in-place processes allow parts of the equipment or an entire process system to be cleaned without being dismantled, reducing the need for disassembling and connect

44、ions under clean conditions. For example, tanks, vessels, freeze-dryers piping and other processing equipment used for manufacture may be cleaned in place. The clean-in-place process is in most instances followed by sterilization-in-place process (described in ISO 13408-5). While clean-in-place and

45、sterilization-in-place methods differ considerably in technology, the concept of in situ treatment is similar. Design considerations of all systems are critical to ensure that clean-in-place technologies can be successfully applied to clean manufacturing equipment to the desired level of cleanliness

46、. BS EN ISO 13408-4:2011BS EN ISO 13408-4:2011INTERNATIONAL STANDARD ISO 13408-4:2005(E) ISO 2005 All rights reserved 1Aseptic processing of health care products Part 4: Clean-in-place technologies 1 Scope This part of ISO 13408 specifies the general requirements for clean-in-place (CIP) processes a

47、pplied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This part of ISO 13408 is applicable to processes where cleaning agents are delivered to the internal

48、 surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer. This part of ISO 13408 does not supersede or replace national regulatory requirements, s

49、uch as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 13408-1, Aseptic processing of health care products Part 1: General requirements ISO/IEC 90003, Software engineering Guidelin