ISO-13408-2-2003.pdf
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1、 Reference number ISO 13408-2:2003(E) ISO 2003 INTERNATIONAL STANDARD ISO 13408-2 First edition 2003-03-15 Aseptic processing of health care products Part 2: Filtration Traitement aseptique des produits de sant Partie 2: Filtration ISO 13408-2:2003(E) PDF disclaimer This PDF file may contain embedde
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6、 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 2003 All rights reserved -,-,- ISO 13408-2:2003(E) ISO 2003 All rights reserved iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative referenc
7、es .1 3 Terms and definitions.1 4 General requirements.3 5 Selection of filters and filter assemblies based on filter manufacturers data.3 6 Fluid-specific selection criteria based on filter users data3 7 Filtration process4 7.1 Process parameters4 7.2 Validation of fluid-specific microbial retentio
8、n by filters5 8 Filtration system design.7 9 Routine process8 10 Process documentation .8 11 Maintenance and change control9 12 Operator training.9 Annex A (informative) Basic information and quality certificates for filter cartridges.10 Bibliography .11 ISO 13408-2:2003(E) iv ISO 2003 All rights re
9、served 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 wh
10、ich 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
11、matters of electrotechnical standardization. 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 ci
12、rculated to the member bodies for voting. Publication 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 respo
13、nsible for identifying any or all such patent rights. ISO 13408-2 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:
14、 Filtration The following parts are under preparation: Part 3: Freeze-drying Part 4: Sterilization in place Part 5: Cleaning in place Part 6: Isolator/barrier technology ISO 13408-2:2003(E) ISO 2003 All rights reserved v Introduction During the process of preparing ISO 13408-1:1998, which addresses
15、general requirements, several items, e.g. filtration, freeze-drying and steam-in-place, were found to be in need of supplementary information which was too large to be given in corresponding Annexes. This part of ISO 13408 includes requirements and guidance that are to be observed when aseptically m
16、anufacturing health care products by filtration. ISO 13408-1:1998 will be revised soon after the publication of this part of ISO 13408, as clause 20 of ISO 13408-1:1998 is replaced by this part of ISO 13408. -,-,- -,-,- INTERNATIONAL STANDARD ISO 13408-2:2003(E) ISO 2003 All rights reserved 1 Asepti
17、c processing of health care products Part 2: Filtration 1 Scope This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine o
18、peration of a sterilizing filtration process, to be used for aseptic processing of health care products. This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filt
19、er (e.g. bacterial whole-cell vaccines). 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 amendm
20、ents) applies. ISO 13408-1:1998, Aseptic processing of health care products Part 1: General requirements ISO/TS 11139:2001, Sterilization of health care products Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 13408-1, ISO/TS 11139 and the
21、 following apply. 3.1 bacterial challenge test test to evaluate the capability of a filter to retain organisms from a bacterial suspension under defined conditions 3.2 bioburden population of viable microorganisms in a fluid prior to sterilizing filtration NOTE For the purposes of this part of ISO 1
22、3408, the definition of bioburden is narrower than that in ISO/TS 11139. 3.3 chemical compatibility ability of the process fluids not to adversely affect the properties of filter materials and/or filter assembly components and vice versa 3.4 fibre particle having an aspect (length-to-width) ratio of
23、 10 or more ISO 14644-1:1999, 2.2.7 -,-,- ISO 13408-2:2003(E) 2 ISO 2003 All rights reserved 3.5 fibre-releasing filter filter which, even after any appropriate treatment such as washing or flushing, will release fibres into the filtrate 3.6 filter porous material through which a liquid or a gas is
24、passed to remove viable and non-viable particles 3.7 filter assembly filter cartridge(s) or filter material installed into a housing or holder NOTE This can be done by the filter user or by the filter manufacturer, e.g. in the form of pre-assembled filter units. 3.8 filter cartridge filter material
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