BS EN 12296-1998 Biotechnology - Equipment - Guidance on testing procedures for cleanability《生物技术 设备 清洁处理试验程序指南》.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12296:1998 The Euro
2、pean Standard EN 12296:1998 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Equipment Guidance on testing procedures for cleanabilityThis British Standard, having been prepared under the direction of the
3、Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 August 1998 BSI 1998 ISBN 0 580 30067 6 BS EN 12296:1998 Amendments issued since publication Amd. No. Date Text affected National foreword This British Standard is the Engli
4、sh language version of EN 12296:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible international European committee any enquiries on the interpreta
5、tion, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which im
6、plement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not pu
7、rport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front
8、 cover, the EN title page, pages 2 to 7 and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved
9、worldwide for CEN national Members. Ref. No. EN 12296:1998 E EUROPEAN STANDARD EN 12296 NORME EUROPE ENNE EUROPA ISCHE NORM March 1998 ICS Descriptors: Biotechnology, medical equipment, cleaning, disinfection, contamination, micro-organisms, noxious micro-organisms, tests, safety, hygiene conditions
10、, inspection, accident prevention, environmental protection, work safety English version Biotechnology Equipment Guidance on testing procedures for cleanability Biotechnologie Equipement Guide des proce dures dessai pour le contro le de la capacite au nettoyage Biotechnik Gera te und Ausru stungen L
11、eitfaden fu r Verfahren zur Pru fung der Reinigbarkeit This European Standard was approved by CEN on 2 March 1998. 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
12、alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by t
13、ranslation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irela
14、nd, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12296:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233, Biotechnology, the secretariat of which is held by AFNOR. This European Standard shal
15、l be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 1998, and conflicting national standards shall be withdrawn at the latest by September 1998. According to the CEN/CENELEC Internal Regulations, the national standard
16、s organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page
17、Foreword 2 Introduction 3 1 Scope 3 2 Definitions 3 3 Testing 4 4 Documentation 4 Annex A (informative) Selection guide on test methods for cleanliness 5 Annex B (informative) Information on test methods for cleanliness 6 Annex C (informative) Bibliography 7Page 3 EN 12296:1998 BSI 1998 Introduction
18、 The cleaning of plant and equipment is an essential element of biotechnology processes in order to protect the safety of people and the environment and to avoid harmful operational effects through the accumulation of soil. Testing procedures should be developed and documented to ensure that relevan
19、t information on cleanability is available. Standards (e.g. EN ISO 9000 series, see annex C 9), guidelines (e.g. Good Manufacturing Practice (GMP) see annex C 10) state general procedures of good practice which facilitate high quality manufacturing if followed. This European Standard refers to asses
20、sing the cleanability of equipment used in biotechnology, where additional specific requirements related to safety and to special features of biotechnological processes are required. It should be read in association with the more general standards and guidelines as mentioned above. In particular thi
21、s European Standard states the principles on which test methodology is based. Informative guidance on selection of test methods is provided in annex A. The extent to which it is necessary to remove soil from equipment and plant varies substantially with the process. In some cases abundant residues a
22、fter cleaning do not harm people or the environment or do not cause difficulties in the process. In others very low residues are essential. The complete removal of soil on surfaces cannot be achieved, because for example all surfaces are adsorptive to some degree. 1 Scope This European Standard give
23、s guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous micro-organisms. This European
24、Standard also applies to non-hazardous micro-organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes. This European Standard applies to plants or components such as, valves and fitting, tanks, pumps, piping,
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