1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1620 : 1997 The Eur
2、opean Standard EN 1620 : 1996 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 Plant building according to the degree of hazardBS EN 1620 : 1997 This British Standard, having been p
3、repared 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 March 1997 BSI 1997 The following BSI references relate to the work on this standard: Committee reference CII/58 Draft for comment 94/5063
4、54 DC ISBN 0 580 26775 X Amendments issued since publication Amd. No. Date Text affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CII/58, Biotechnology, upon which the following bodies were represented: Association
5、 of Consultants to the Bioscience Industries (Acbi) BLWA 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 H
6、ealth Department of the Environment (Air Climate and Toxic 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 Soci
7、ety for Applied Bacteriology Society for General MicrobiologyBS EN 1620 : 1997 BSI 1997 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Introduction 3 Text of EN 1620 3ii BSI 1997 BS EN 1620 : 1997 National foreword This British Standard has been prepared by
8、 Technical Committee CII/58 and is the English language version of EN 1620 : 1996 Biotechnology Large-scale process and production Plant building according to the degree of hazard, published by the European Committee for Standardization (CEN). EN 1620 is the result of European discussion in which th
9、e UK took a full part. 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 cover, pages i and ii, the EN title page, pages 2 to 10, an inside back cover and a back cover.CEN European Com
10、mittee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN 1620 : 1996 E EUROPEAN STANDARD EN 1620 NORME EUROPE ENNE EUROPA ISCHE NORM July 1996 ICS 07.100
11、.00 Descriptors: Biotechnology, residential buildings, design, specifications, safety, accident prevention, environmental protection, hazards, contamination, micro-organisms, level: quantity English version Biotechnology Large-scale process and production Plant building according to the degree of ha
12、zard Biotechnologie Proce de a grande e chelle et production Installation industrielle selon le niveau de danger Biotechnik Verfahren im Gromastab und Produktion Geba ude entsprechend dem jeweiligen Gefa hrdungsgrad This European Standard was approved by CEN on 1996-05-02. CEN members are bound to c
13、omply with the CEN/CENELEC Internal Regulations 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
14、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 translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the
15、official versions. CEN members are the national standard bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 1620 : 1996 BSI 1997 Foreword This European Stan
16、dard 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 identical text or by endorsement, at the latest by January 1997, and conflicting na
17、tional standards shall be withdrawn at the latest by January 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, I
18、reland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 General considerations 4 5 Design requirements 4 Annexes A (informative) Classification of the mic
19、ro-organisms 9 B (informative) Bibliography 10Page 3 EN 1620 : 1996 BSI 1997 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 European Standard supports industrial
20、 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 annex B 1, 2). NOTE. Non-genetically modified micro-organisms include
21、natural micro-organisms and micro-organisms improved by traditional techniques. The plant buildings used for biotechnological processes vary widely. The characteristics of each plant building will be dictated by the physical containment to be used at each stage of operation based on risk assessment.
22、 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 micro-organisms, a case by case analysis should be done. 1 Scope This European Standard specifies design requirements for plant buildings used f
23、or 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 emission concerning the design
24、requirements. Plant buildings include buildings intended, if necessary, to contain all the fermentors and downstream processing apparatus. Plant building design includes design of equipment linked to the building itself and excludes specific production equipment. NOTE 2. Equipment implementation is
25、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 quality, for which attention is drawn to relev
26、ant 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 at the appropriate places
27、in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred
28、 to applies. prEN 12075 Biotechnology Large scale process and production Procedures for fermentations and downstream processes prEN 12307 Biotechnology Large scale process and production Personnel: Guidance for good practice, procedures, training and control 3 Definitions For the purposes of this st
29、andard, the following definitions apply: 3.1 biohazard Intrinsic potential property or ability of micro-organisms/organisms, and/or biologically active substances to cause harm. 3.2 closed phase Period during which the micro-organisms/organisms are separated by a barrier from the environment. 3.3 cl
30、osed system System where a barrier separates micro-organisms/ 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-organisms/organisms from within the controlled area. 3.5 hazard Intrinsic potentia
31、l property or ability of something (e.g. any agent, equipment, material or process) to cause harm. NOTE. Harm is an injury or damage to health of people and/or to the environment. 3.6 inactivation Destruction of micro-organisms. 3.7 micro-organism Any microbiological entity, cellular or non cellular
32、, 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 90/679/EEC: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be
33、 able to provoke any infection, allergy or toxicity. 3.8 open phase Period during which the micro-organism/organism is not separated by a barrier from the environment. 3.9 open system System where there is no barrier between the micro-organism/organism and the environment.Page 4 EN 1620 : 1996 BSI 1
34、997 3.10 physical containment System for confining a micro-organism/organism 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 into the working environment. NOTE. This can involve the use of c
35、losed containers or appropriate equipment together with secure operating procedures. 3.12 risk Probability of occurrence of a hazard causing harm and the degree of severity of the harm. 3.13 secondary physical containment System of physical containment which limits the escape of a micro-organism/org
36、anism into the environment or into other working areas. NOTE. This 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 ph
37、ysical containment. 4 General considerations As a preliminary, a risk assessment shall be carried out on the process to determine the likely containment levels. The following safety aspects shall be taken into consideration, where appropriate, when handling micro-organisms: protection of personnel;
38、protection of the environment; protection of the product. Buildings shall 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 exposure to the biohazard; c) the mode of handling: open or
39、closed system, open or closed phase. The result shall be the establishment of controlled areas giving the required levels of containment. 5 Design requirements 5.1 Plant building in general Table 1 gives a combination of measures which may be combined to give necessary levels of containment. However
40、, it is emphasized that it may be appropriate to select and combine requirements from different containment levels on the basis of risk assessment related to any particular process or part of a process. Particularly, plant design which is intended for secondary physical containment, shall be adapted
41、 to the level and reliability of primary physical containment. It is also necessary to comply with national and European regulations. For micro-organisms pathogenic only to plants or animals, but not to humans, requirements for building design shall be adapted, case by case according to the type and
42、 the degree of hazard of this micro-organism. These considerations shall include the epidemiological situations of the plant or animal pathogens (e.g. endemic area). Plant buildings should be designed to permit effective application of the principles of good occupational safety and hygiene (GOSH) (s
43、ee annex B 4) and good industrial large scale practice (GILSP) (see annex B 5). Plant buildings shall be easy to clean and maintain. Plant buildings shall be designed in order to permit control of gas, liquid and solid releases, where appropriate, in accordance with national and European regulations
44、. NOTE. A standard Guidance for the handling, inactivating and testing of waste is being prepared (see annex B 8). The main points to be considered are listed as follows: a) barriers between outside and inside controlled areas such as walls, floors, ceilings, doors, windows; b) retention system to r
45、etain spillage/leakage of the content of a closed system; c) inlet/outlet from a controlled area for: liquids; solids; gas; personnel (see prEN 12307); equipment; communication; energy. 5.2 Plant building design for containment level 1 There are no special design requirements except general requirem
46、ents. Special requirements only intended to protect the product if necessary, are outside the scope of this standard but they should be considered together with general design requirements. Building design containment level 1 corresponds to a basic building used for fermentation. NOTE 1. Some fermen
47、tations and/or some contained downstream processes, are carried out outside a building; these correspond to a closed system outside of a 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
48、fermentation). In this case this standard can be applicable. NOTE 2. A standard Procedures for fermentation and downstream processes is being prepared (see prEN 12075).Page 5 EN 1620 : 1996 BSI 1997 5.3 Plant building design for containment level 2 A containment level 2 plant building shall be desig
49、ned so as to minimize the escape of micro-organisms (see table 1). The following requirements shall be observed in addition those specified in 5.1 and 5.2: a) the controlled area shall be clearly identified; b) bench surfaces shall be easy to clean and disinfect; c) doors and windows shall be closeable; d) where appropriate, the controlled area shall be adequately ventilated to minimize air contamination; e) a biomass inactivation system shall be available; f) where appropriate, the controlle
