1、STD-BSI BS EN 3b20-ENGL 3777 3b24bb7 0577735 782 BRITISH STANDARD Biotechnology - Large-scale process and production - Plant building according to the degree of hazard BS EN 1620 : 1997 The European Standard EN 1620 : 1996 has the status of a British Standard ICs 07.080 NO COPYING WITHOUT BSI PERMIS
2、SION EXCEPT AS PERMITTED BY COPYRIGHT LAW STD=BSI BS EN Lb20-ENGL 1997 m Lb24bb7 05977Lb bL9 m BS EN 1620 : 1997 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 ef
3、fect on 15 March 1997 O BSI 1997 Committees responsible for this British Standard The preparation of this British Standard was entsusted to Technical Committee CIv58, Biotechnology, upon which the foilowing bodies were represented: Association of Consultants to the Bioscience Industries (Acbi) BLWA
4、Ltd. (the Association of the Laboratory Supply Industry) Bioindustry Association Brewing Research Foundation International British Agrochemicals Association Ltd. Chemical Industries Association Confederation of British Industry Department of Health Department of the Environment (Air Climate and bxic
5、 Directorate) Health and Safety Executive Institution of Chemical Engineers International Society for Pharmaceutical Engineering Ministry of Agriculture, Fisheries and Food National Engineering Laboratory Public Health Laboratory Service Society for Applied Bacteriology Society for General Microbiol
6、ogy Amendments issued since publication ID* I Te*affected The foliowing BSI references relate to the work on this standard Committee reference CIV5 Draft for comment 94506354 DC ISBN O 680 26776 X I l STD*BSI BS EN Lb20-ENGL 3777 W Lb24bb7 0577737 555 W BS EN 1620 : 1997 Contents page Committees res
7、ponsible Inside front cover National foreword ii Foreword 2 Introduction 3 Text of EN 1620 3 * m x. O BSI 1997 i STD-BSI BS EN LbZO-ENGL 3777 m Lb24bb7 0577738 471 m BS EN 1620 : 1997 National foreword This British Standard has been prepared by Technical Committee CW58 and is the English language ve
8、rsion of EN 1620 : 1996 Biotechnology - Large-scale process and pmdzlction -Plant buding according to the degree of hazard, published by the European Committee for Standanhation (CEN). EN 1620 is the result of European discwion in which the UK took a full part. Compliance with a British Standard doe
9、s not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 10, an inside back cover and a back cover. ii O BSI 1997 STD-BSI BS EN LbZU-ENGL 1997 1b2LibbS 0599739 328 = EUROPEAN m
10、wm EN 1620 NORME EUR0PEE”E EUROPISCHE NORM July 1996 ICs 07.100.00 Descriptors: Biotechnology, residential buildings, design, specifications, safety, accident prevention, environmental protection, hazards, contamination, micro-organisms, level quantity English version Biotechnology - Large-scale pro
11、cess and production - Plant buil- according to the de- of hazard Biotechnologie - Procd grande chelle et production - Installaton indushielle selon le niveau de danger Gefahrdungsgrad Biotechnik - Verfahren im Groi3maastab und Produktion - Gebude entsprechend dem jeweiligen This European Standard wa
12、s approved by CENon199G0502. CENmembers are bound to compiy with the CENKENELEC Interd Regdations which stipulate the conditions for giving this European Standard the status of a nationa standard without any altemtion. Uptodate lists and biblographical references concerning such national standards m
13、ay be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, Gexman). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Ce
14、ntrai Secretariat has the same status as the official versions. CENmembers are the national standard bodies of A- Belgium, Denmark, Finland, France, Ge- Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kmgdom. CEN European Committee fo
15、r Standaraion Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1060 Brussels O 1996 Copynght reserved to CEN members Ref. No. EN 1620 : 1996 E STD-BSI BS EN Lb20-ENGL 1777 1b24bb7 0577720 OqT Page 2 EN 1620 : 1996 Foreword This European Standar
16、d has been prepared by kchnical Committee CENBC 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 identical txt or by endorsement, at the latest by January 1997, and conflicting national
17、 standads shall be withdrawn at the latest by January 1997. According to the CENKENELEC Internai Regulations, the national standards organizations of the following counties are bound to implement this European Standard Austria, Belgium, Denmark, Fnland, France, Germany, Greece, Iceland, Jrehd, Italy
18、, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Foreword Introduction 1 Scope 2 Normative references 3 Denitions 4 General considerations 6 Design requirements Annexes A (informative) Classifkation of the B (iormative) Bibliography micro-organ
19、isms Page 2 3 3 3 3 4 4 9 10 O BSI 1997 STD-BSI BS EN Lb20-ENGL 1977 H Lb24bb7 0599723 Tb Page 3 EN 1620 : 1996 Introduction This European standard covers a wide area of application of biotechnology, both areas which are not subject to biotechnology legislation and those which are regulated. This Eu
20、ropean Standard supports industriai activities in the area of biotechnology covering operations with including non-genetically modified micro-organisms and genetically modified micro-organisms (GMMs) and with both non-pathogenic and pathogenic micro-organisms (see NOTE. Non-genetically modified micr
21、oorganisms include naturai micro-organisms and microorganisms improved by traditional techniques. The plant buildings used for biotechnological processes vary widely The characteristics of each plant building wili be dictated by the physical containment to be used at each stage of operation based on
22、 risk assessment. This assessment can indicate that some requirements in a given situation are not necessary or that a higher level is needed. For animal and plant pathogen micmrganisms, a case by case analysis should be done. annex B VI, Pl). 1 Scope This European Standard specifies design requirem
23、ents for plant buildings used for the safe handling of micro-organisms and the product itself if it presents a biohazard NOTE 1. When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental e
24、mission concerning the design requirements. Plant buildings include buildings intended, if necessary, to contain all the fermentom and downstream processing apparatus. Plant building design includes design of equipment linked to the building itself and excludes specific production equipment. NOTE 2.
25、 Equipment implementation is covered by a standard Equipment implementation according to the degree of hazard which is being prepared (see annex B 3). This European Standard is not applicable to design requirements which affect good manufacturing practice (see annex B 6) or product quaJi, for which
26、attention is dram to relevant codes of practice and national regulations. It would be advisable to consider both aspects simultaneously 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited a
27、t the appropriate places in the kxt and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard oniy when incorporated in it by amendment or revision. For undated references the latest edition of
28、the publication referred to applies. prEN 12075 Biotechnology - Large scale process and production - Procedures f frrnentut.ions and downstream p-OCeSSeS prEN 12307 Biotechnology - Large scale pmcess and production- Personnel: Guidance for good practice, procedures, training and COntrol 3 Denitions
29、For the purposes of this standard, the following definitions apply: 3.1 biohazard Intrinsic potential property or ability of micro-organismdorganisms, and/or biologically active substances to cause harm. 3.2 closed phase Period during which the micro-organisdorganisms are separated by a barrier from
30、 the environment. 3.3 closed system System where a barrier separates micrwrganisms/ organisms from the environment. 3.4 controlled area Area constructed and/or operated in such a manner as to limit contamination of the other areas by micro-organismdorganisms from within the controlled 3.6 hazard Int
31、rinsic potential property or ability of something (e.g. any agent, equipment, material or process) to cause hann. NOTE. Harm is an injury or damage to health of people and/or to the environment. 3.6 inactivation Destruction of micrwrganisms. 3.7 micro-organism Any microbiological enti, cellular or n
32、on celuar, capable of replication or of transferring genetic material (EN 1619). NOTE. The term micro-organism covers the term of biological agent, according to the Directive 90/679EEC: microorganisms, including those which have been genetically modified, cell cultures and human endoparasites, which
33、 may be able to provoke any infection, allergy or toxicity. 3.8 open phase Period during which the rnicro-organisndorganism is not separated by a barrier from the environment. 3.9 open system System where there is no barrier between the micro-organisdorganism and the environment. area O BSI 1997 STD
34、-BSI BS EN LbZU-ENGL 1997 LbZibbS 0599722 912 Page 4 EN 1620 : 1996 3.10 physical containment System for confining a micro-organisdorganisrn or other entity within a defined space. 3.11 primary physical containment System of physical containment which limits the escape of a micro-organism/organism i
35、nto the working environment. NOTE. This can involve the use of closed containers or appropriate equipment together with secure operating procedures. 3.12 risk ProbabWy of occurrence of a hazard cawing haSm and the degree of seventy of the harm. 3.13 secondary physical containment System of physical
36、containment which limits the escape of a micro-organismlorgankm into the environment or into other workjng areas. NOTE. This can involve the use of rooms with specially designed air handiing, the existence of airlocks andor sterilizers for the removal of materiais and secure operating procedures. in
37、 many cases it can add to the effectiveness of primary physical containment. 4 General considerations As a preliminary, a risk assessment shall be carried out on the process to determine the likely containment levels. The foliowing safety aspects shall be taken into consideration, where appropriate,
38、 when handling micrclorganisms: -protection of personnel; -protection of the environment; - protection of the product. Buildmgs shaii be designed to prevent the potential risks by taking into account: a) the degree of biohazard NOTE. Annex A gives a common basis for classification. b) the route of e
39、xposure to the bio-, c) the mode of handling: open or closed system, open or closed phase. The result shall be the establishment of controlled areas giving the required levels of containment. 5 Design requirements 6.1 Plant building in general Table 1 gives a combination of measures which may be com
40、bined to give necessary levels of containment. However, it is emphasized that it may be appropriate to select and combine requirements b) retention system to retain spillageneakage of the content of a closed system; c) inletoutlet from a controiled area for - liquids, - solids, - gas; -personnel (se
41、e prEN 12307); - equipment; - communication; - energy. 6.2 Plant building design for containment level 1 There are no special design requirements except generai requirements. Special requirements only intended to protect the product if nec-, are outside the scope of this standard but they should be
42、considered together with generai design requirements. Building design containment level 1 corresponds to a basic building used for fermentation. NOTE 1. Some fermentations andor some contained downstream processes, are carried out outside a building; these correspond to a closed system outside of a
43、controlled area in this case, this standard can not be applicable. Some fermentations are carried out in an open system in a controlled area (for instance cheese fermentation). In this case this standard can be applicable. NOTE 2. A standard Procedures for fermentation and downstream processes is be
44、ing prepared (see prEN 12075). O BSI 1997 STD.BS1 BS EN Lb20-ENGL 1777 lb24bb7 0577723 857 Page 5 EN 1620 : 1996 6.3 Plant building design for containment level 2 A containment level 2 plant building shall be designed so as to minimize the escape of micro-organisms (see table 1). The following requi
45、rements shall be observed in addition those specified in 6.1 and 6.2: 6.6 Plant building design for containment level 4 For a containment level 4 builduig, special requirements are necessary and are determined, case by case, by the national authorities. The minimum requirements to prevent the escape
46、 of micro-organisms axe given in table 1. a) the controlled area shall be clearly identified; b) bench surfaces shall be easy to clean and disinfect; c) doors and windows shaU be closeable; d) where appropriate, the controlled area shaii be adequately ventilated to minimize air contaminati on; e) a
47、biomass inactivation system shall be available; f) where appropriate, the controlled area shall be designed to retain spillage; g) where appropriate, a system shall be provided to inactivate biological effluents before final discharge. 6.4 Plant building design for containment level 3 A containment
48、level 3 plant building shall be designed so as to prevent the escape of micreorgankms (see table 1). The following requirements shall be observed in addition to those specified in 6.1, 6.2 and 6.3: a) the workplace shall be separated from any other activities in the same builing. The work itreas sha
49、il be clearly identied and indicated (biohazard sign); b) windows shaJ be sealed; c) where appropriate, an observation window or alternative shall be installed $o that the room can be seen; d) all extract air shall be exhausted through a high efficiency particulate air (HEPA) filter. HEPA filters shall be sited so that they are accessible for testing and to allow their safe removal; e) where appropriate, the controlled asea shall be maintained at an air pressure negative to the surrounding areas. An alam system shall be fitted to detect unacceptabl
