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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12460:1998 The Euro
2、pean Standard EN 12460:1998 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Large-scale process and production Guidance on equipment selection and installation in accordance with the biological risk Licensed Copy: s
3、heffieldun sheffieldun, na, Sat Oct 28 05:24:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 July 1998 B
4、SI 1998 ISBN 0 580 29844 2 BS EN 12460:1998 Amendments issued since publication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 12460:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, whic
5、h has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A
6、list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled Internati
7、onal Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British
8、 Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 7 and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:39 GMT+00:00 2006, Uncontrolled Copy, (c)
9、 BSI 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 worldwide for CEN national Members. Ref. No. EN 1246
10、0:1998 E EUROPEAN STANDARDEN 12460 NORME EUROPE ENNE EUROPA ISCHE NORM February 1998 ICS 07.080 Descriptors: Biotechnology, work safety, classifications, hazards, microorganisms, transgenic organisms, contamination, accident prevention, environmental protection, laboratory equipment, containment enc
11、losures English version Biotechnology Large-scale process and production Guidance on equipment selection and installation in accordance with the biological risk Biotechnologie Proce de a grande e chelle et production Guide pour la se lection et linstallation des e quipements en fonction du risque bi
12、ologique Biotechnik Verfahren in Gromastab und Produktion Leitfaden zur Auswahl und Installation von Gera ten und Ausru stungen entsprechend dem biologischen Risiko This European Standard was approved by CEN on 31 January 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulation
13、s which stipulate the conditions for giving this European Standard 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 Central Secretariat or to any CEN member. This Europea
14、n Standard exists in three official versions (English, French, 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 Central Secretariat has the same status as the official versions. CEN members are the nationa
15、l standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:39 GMT+00:00 2006, Uncont
16、rolled Copy, (c) BSI Page 2 EN 12460:1998 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 shall be given the status of a national standard, either by publication of an ident
17、ical text or by endorsement, at the latest by August 1998, and conflicting national standards shall be withdrawn at the latest by August 1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stand
18、ard: 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 Foreword2 1Scope3 2Definitions3 3Procedure for selection of equipment4 4Verification
19、of performance in practice5 5Control5 6Documentation5 Annex A (informative) Examples of a risk analysis6 Annex B (informative) Bibliography6 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12460:1998 BSI 1998 1 Scope This European
20、Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of this into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new
21、 process or significant changes are introduced into an existing plant. This European Standard applies if the biotechnological process includes the use of hazardous or potentially hazardous microorganisms and/or if the emission of such microorganisms into the working place and/or environment are rest
22、ricted. However, this should be considered only as a part of the total safety approach required. Attention is drawn to relevant European and national regulations. 2 Definitions For the purposes of this standard, the following definitions apply. 2.1 ancillary unit of equipment unit of equipment that
23、is not in direct contact with the product, but which is nevertheless necessary to perform a process NOTEExamples of ancillary units of equipment are solvent recovery units for re-use of solvents, cleaning-in-place (CIP) units for preparation and storage of cleaning solutions. 2.2 component of equipm
24、ent technical entity which forms part of a unit of equipment NOTEExamples of components of equipment are vessels, valves and sensors. 2.3 hazard intrinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN 1620 NOTEHarm is an injury or damage
25、 to health of people and/or to the environment. 2.4 microorganism any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619 NOTEFor the purpose of this standard, the term microorganism covers the term of biological agent, according to th
26、e Directive 90/679/EEC: microorganisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity. 2.5 physical containment system for confining a microorganism or organism or other entity within a def
27、ined space EN 1620 2.6 primary physical containment system of physical containment which limits the escape of a microorganism or organism into the working environment NOTEThis can involve the use of closed containers or appropriate equipment, together with secure operating procedures. 2.7 process co
28、mbination of unit operations for the production of a defined product and waste 2.8 process equipment unit of equipment which is in direct contact with the product NOTEExamples of process equipment are bioreactors, filters and separators. 2.9 process microorganism microorganism used for production pu
29、rposes in a biotechnological process or constituting (part of) the product itself 2.10 process step individual defined part of the process which performs a specific function NOTEOne combination of unit operations constitutes a process step. For example, downstream process could consist of separation
30、, extraction, concentration and drying. 2.11 risk probability of occurrence of a hazard causing harm and the degree of severity of the harm 2.12 secondary physical containment system of physical containment which limits the escape of a microorganism or organism into the environment or into other wor
31、king areas NOTEThis can involve the use of rooms with specially designed air handling, the existence of airlocks and/or sterilizers for the removal of materials, and secure operating procedures. In many cases it can add to the effectiveness of primary physical containment. 2.13 unit of equipment ass
32、embly of components used to perform one or more unit operations 2.14 unit operation operation to perform a single chemical, physical or mechanical activity NOTEExamples of unit operation are heat transfer, mixing, separation (including filtration and centrifugation) and sterilization. 2.15 utilities
33、 units of equipment which supply energy and media NOTEExamples of utilities are units of equipment to generate and supply steam and pressurized air. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12460:1998 BSI 1998 3 Procedure fo
34、r selection of equipment 3.1 General approach In order to achieve a safe process through a selection of the appropriate equipment, it is necessary to define the process microorganism and the product, the process itself and the equipment proposed. An initial risk analysis should be carried out in ord
35、er to determine the appropriate performance criteria of the proposed equipment. Based on this initial risk analysis, a detailed design should be carried out and equipment selected. This should be followed by a detailed risk analysis, based on the specifications of equipment selected and its anticipa
36、ted assembly into a plant. After the plant is assembled, verification should be carried out with respect to installation, operation and maintenance. Any subsequent changes in microorganism, process and/or equipment should lead to a repeat of the initial risk analysis as a minimum. NOTEAn example of
37、how to perform such a risk analysis is given in annex A. 3.2 Microorganism(s) The microorganism(s) used in the process should be classified in accordance with its hazards. National and European rules of classification should be followed (see annex B 1 and 2). NOTEConsideration should be given not on
38、ly to pathogenicity, but also to the other biological hazards such as allergenicity, irritation, toxicity or harm to the environment. 3.3 Process and equipment description A fully written process description should be prepared with all process steps listed and their relationships defined. NOTE 1Flow
39、 sheets and/or block diagrams may be used as part of a detailed process description. The process equipment should be listed along with any ancillary units of equipment and utilities. This list facilitates the evaluation of the process with respect to hazard and risk. NOTE 2For each process step (e.g
40、. downstream process) there are a number of unit operations (e.g. separation, extraction, concentration) which require process equipment (e.g. centrifuge, filter, homogenizer) assembled from components (e.g. vessel, membrane support, valves, sensor). NOTE 3It is possible for a piece of process equip
41、ment to be used for more than one process step, potentially involving different unit operations; e.g. a fermenter vessel can be used for fermentation (fermentation process step) or as a kill tank (downstream process step). 3.4 Initial risk analysis An initial risk analysis should be made of the draf
42、t process and equipment description as generated under 3.3. This analysis should be made with regard to the biological hazards, the probability of emission of microorganisms from the equipment and the potential routes of exposure of workers and of the environment, in accordance with national regulat
43、ions. NOTE 1Chemical or physical hazards should be identified and considered alongside the biological hazards, to ensure that the overall risks are not increased: for example, using disinfectant to kill microorganisms where the use of disinfectant is more of a risk than the living microorganisms. Th
44、e objective of the risk analysis is to ensure the selection of and installation of the necessary process equipment in order to remove or reduce as far as possible the identified risks while still achieving the main objective of making a product. The depth and/or detail of the risk analysis will depe
45、nd on a number of factors, such as: the type and/or magnitude of hazards involved; the history and/or experience of the industry; the practical evidence of safe use of the components and process equipment; the tradition or novelty of the process. NOTE 2A suggested approach to the hazard or risk eval
46、uation is to use established techniques such as HAZOP (see annex B 3, 4) and HACCP (see annex B 5, 6, 7), which are used in the chemical and food industries respectively, or other approaches of risk assessment (see annex B 8). The containment measures required to reduce the risk and to select the ty
47、pe of process equipment should be determined. The risk at each process step should then be assessed by examining the probability of emission from the equipment, and the exposure of workers and the environment to the microorganism(s). NOTE 3In order to attain the required protection of the workers an
48、d the environment, containment measures to be applied could be, for example: for a negligible risk, good occupational safety and hygiene (GOSH) practice (see annex B 9); for a low risk, GOSH plus the requirement to minimize release; for a medium risk, GOSH plus the prevention of release; or for a hi
49、gh risk, special requirements on a case-by-case analysis. 3.5 Detailed design of plant A detailed design of the proposed plant should be drawn up covering the selection and assembly of equipment, which should comply with the assessed containment requirements. NOTE 1The performance criteria for classification of units of equipment and components such as centrifuges, cell disrupters, bioreactors, tubes or couplings, with regard to cleanability, sterilizability and leaktightness are defined in individual
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