ISO-13408-1-1998.pdf
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1、A Reference number ISO 13408-1:1998(E) INTERNATIONAL STANDARD ISO 13408-1 First edition 1998-08-01 Aseptic processing of health care products Part 1: General requirements Traitement aseptique des produits de sant Partie 1: Exigences gnrales Copyright International Organization for Standardization Pr
2、ovided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 19:42:22 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 13408-1:1998(E) ISO 1998 All rights reserved. Unless otherwise specified, no part of this publication
3、may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case postale 56 CH-1211 Genve 20 Switzerland Internetisoiso.ch Printed in Switze
4、rland ii ContentsPage 1 Scope.1 2 Definitions.1 3 Quality management systems.5 4 Personnel.5 5 Facility design7 6 Aseptic Processing Area (APA).8 7 Support areas outside the APA9 8 Environmental air systems and controls9 9 Gowning.10 10 Cleaning and disinfection of the APA.11 11 Qualification of equ
5、ipment and utilities, and process validation.12 12 Materials and equipment delivered to aseptic areas12 13 Processing time .13 14 Environmental monitoring programmes.13 15 Alert and action levels15 16 Investigations and reports15 17 Media fills (process simulation tests).16 18 Finished-product steri
6、lity testing 23 19 Steam-in-place.23 20 Process filtration 24 21 Freeze-drying.25 Annex A (informative) Derivation of contamination-rate calculations for a given number of media-filled units29 Annex B (informative) Bibliography.31 Copyright International Organization for Standardization Provided by
7、IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 19:42:22 MDTNo reproduction or networking permitted without license from IHS -,-,- ISOISO 13408-1:1998(E) iii Foreword ISO (the International Organization for Standardization) is a worldwide federati
8、on 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 that committee
9、. 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. Draft International Standards adopted by the techn
10、ical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 13408-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. I
11、SO 13408 consists of the following parts, under the general title, Aseptic processing of health care products: Part 1: General requirements Part 2: Filtration1) Part 3: Freeze-drying Part 4: Sterilization and cleaning in place1) Part 5: Aseptic processing of solid medical devices Part 6: Isolator/ba
12、rrier technology Annexes A and B of this part of ISO 13408 are for information only. 1) ISO 13408-1 includes normative and informative clauses on these subjects until such time that the more detailed additional parts of ISO 13408 are approved and published. Once such approved International Standards
13、 exist, it is intended that the related clauses included in ISO 13408-1 be deleted. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 19:42:22 MDTNo reproduction or networking perm
14、itted without license from IHS -,-,- ISO 13408-1:1998(E) ISO iv Introduction Health care products that are labeled “sterile“ have to be prepared using appropriate and validated methods. ISO/TC 198 has prepared standards for terminal sterilization of health care products by irradiation (ISO 11137), b
15、y moist heat (ISO 11134), by liquid chemical sterilants (ISO 14160) and by ethylene oxide (ISO 11135). When a health care product is intended to be sterile and cannot be terminally sterilized, aseptic processing provides an alternative. There are two distinct situations in which aseptic processing i
16、s applied: a)the aseptic preparation and filling of solutions; b)the aseptic handling, transfer and packaging of solid products which cannot be terminally sterilized in their final containers. Aseptic processing requires the presterilization of all product parts or components that are in direct cont
17、act with the aseptically filled product. The product is processed in a controlled environment in which microbial and particulate levels are maintained at defined levels and where human intervention is minimized. Aseptic processing is an exacting and demanding discipline. Manufacturers use validated
18、systems, adequately trained personnel, controlled environ- ments and well-documented systematic processes to assure a sterile finished product. While terminal sterilization involves the use of a process of known lethality, the assurance of sterility associated with aseptic processing can only be inf
19、erred as facilities, equipment and people are all factors associated with the process. Product development data should also exist to support the maintenance of sterility by the container and/or closure system following aseptic production. The major elements to be considered in aseptic processing inc
20、lude: a)training of personnel; b)layout and specifications for buildings, equipment and facilities; c)particulate and microbial environmental monitoring programmes; d)systems for water, steam, air and other process gases; e)descriptions of and procedures for manufacturing operations including people
21、, materials, material flow, solution preparation and associated acceptance criteria; f)use and validation of sterilization processes, including disinfection practices; g)validation methods and data requirements for media fills and container/closure systems; h)operating practices for acceptance crite
22、ria, investigation reviews and release/reject decisions. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/12/2007 19:42:22 MDTNo reproduction or networking permitted without license from
23、IHS -,-,- INTERNATIONAL STANDARD ISOISO 13408-1:1998(E) 1 Aseptic processing of health care products Part 1: General requirements 1 Scope This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for the validation and control of asep
24、tically processed health care products. This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. NOTE Future parts of ISO 13408 will address specialty topics related to aseptic processing, including detailed descriptive information concerning var
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