ISO-13408-6-2005.pdf
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1、 Reference number ISO 13408-6:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 13408-6 First edition 2005-06-15 Aseptic processing of health care products Part 6: Isolator systems Traitement aseptique des produits de sant Partie 6: Systmes isolateurs ISO 13408-6:2005(E) PDF disclaimer This PDF file may c
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4、parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless oth
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6、ht office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reserved ISO 13408-6:2005(E) ISO 2005 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normat
7、ive references. 1 3 Terms and definitions. 1 4 Quality system elements 3 4.1 General. 3 4.2 Management responsibility . 3 4.3 Design control. 3 4.4 Measuring instruments and measuring systems 3 5 Design of isolator systems 4 5.1 General. 4 5.2 Types of isolators. 4 5.3 Materials of construction. 4 5
8、.4 Air-handling system . 4 5.5 Operator interface. 5 5.6 Ancillary equipment 6 6 Facility requirements 6 6.1 Surrounding room classification 6 6.2 Process utilities 7 7 User requirements 7 7.1 Product/process application . 7 7.2 Ergonomics . 7 7.3 Cleaning. 7 7.4 Bio-decontamination 8 8 Validation.
9、10 8.1 General. 10 8.2 Design qualification 11 8.3 Installation qualification. 11 8.4 Operational qualification 12 8.5 Performance qualification 13 8.6 Review and approval of validation 14 8.7 Requalification 14 9 Routine monitoring and control 14 9.1 Procedures 14 9.2 System integrity 14 9.3 Bio-de
10、contamination process monitoring . 15 9.4 Environmental monitoring. 15 9.5 Change control 15 9.6 Maintenance and calibration . 15 10 Personnel training 15 Bibliography. 17 ISO 13408-6:2005(E) iv ISO 2005 All rights reserved Foreword ISO (the International Organization for Standardization) is a world
11、wide 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 t
12、hat 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. International Standards are drafted in
13、 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. Publication as an International Standard
14、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 patent rights. ISO 13408-6 was prepared by T
15、echnical 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: Clean-in-place technologies Part 5: Ster
16、ilization in place Part 6: Isolator systems -,-,- ISO 13408-6:2005(E) ISO 2005 All rights reserved v Introduction Health care products that are labelled “sterile” are prepared by using appropriate and validated methods. When a health care product is intended to be sterile and cannot be terminally st
17、erilized, aseptic processing provides an alternative. This applies to the aseptic preparation and filling of solutions, suspensions, emulsions, and solids, as well as to the aseptic handling, transfer and filling of those products which cannot be terminally sterilized. Aseptic processing is an exact
18、ing and demanding discipline. It is essential that manufacturers make use of qualified/validated systems, adequately trained personnel, controlled environments and well-documented systematic processes to assure a sterile finished product. -,-,- INTERNATIONAL STANDARD ISO 13408-6:2005(E) ISO 2005 All
19、 rights reserved 1 Aseptic processing of health care products Part 6: Isolator systems 1 Scope This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator s
20、ystems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. This part of ISO 13408 does not supersede or replace national regulatory requirements, s
21、uch as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to 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 a
22、pplies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 13408-1:1998, Aseptic processing of health care products Part 1: General requirements ISO 13408-4:1), Aseptic processing of health care products Part 4: Clean-in-place technologies I
23、SO 13408-5:1), Aseptic processing of health care products Part 5: Sterilization in place ISO 14644-7:2004, Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) ISO/IEC 90003, Software engineering Guidelines for th
24、e application of ISO 9001:2000 to computer software 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13408-1:1998 and the following apply. 3.1 bio-decontamination removal of microbiological contamination or its reduction to an acceptable level 1) To b
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