BS EN 12885-1999 Biotechnology - Performance criteria for cell disrupters《生物技术 细胞破损器的性能标准》.pdf

1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12885:1999 The Euro

2、pean Standard EN 12885:1999 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for cell disruptersThis British Standard, having been prepared under the direction of the Sector Committee for Materia

3、ls and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 June 1999 BSI 06-1999 ISBN 0 580 32272 6 BS EN 12885:1999 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the English language version of E

4、N 12885:1999. 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 European committee any enquiries on the interpretation, or proposals for change, and kee

5、p 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 implement international or European publ

6、ications 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 purport to include all the necessary pro

7、visions 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 cover, the EN title page, pages 2 to

8、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 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Re

9、f. No. EN 12885:1999 E EUROPEAN STANDARD EN 12885 NORME EUROPE ENNE EUROPA ISCHE NORM February 1999 ICS 07.080; 07.100.01 Descriptors: biotechnology, material, cells (biology), safety, hazards, environmental protection, accident prevention, contamination, microorganisms, definitions, classifications

10、, characteristics, leaktightness, cleaning, sterilization, verification, tests, marking, packing English version Biotechnology Performance criteria for cell disrupters Biotechnologie Crite res de performance pour les broyeurs de cellules Biotechnik Leistungskriterien fu r Zellaufschlugera te This Eu

11、ropean Standard was approved by CEN on 28 January 1999. 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 alteration. Up-to-date lists and bibliographical references

12、 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 translation under the responsiblity of a CEN members into it

13、s 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, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain

14、, Sweden, Switzerland and United Kingdom.Page 2 EN 12885:1999 BSI 06-1999 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

15、 publication of an identical text or by endorsement, at the latest by August 1999, and conflicting national standards shall be withdrawn at the latest by August 1999. This draft European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade As

16、sociation. According to the CEN/CENELEC Internal Regulations, the national standards 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,

17、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 Hazards 4 5 Performance classes 4 6 Classification and verification of performance 5 7 Marking and packaging 6 8 Documentation 6 Annex A (

18、informative) Example of the selection of a leaktightness test method 7 Annex B (informative) Bibliography 7Page 3 EN 12885:1999 BSI 06-1999 Introduction Cell disrupters are used to break or reduce the size of viable or non-viable microorganisms. The term homogenizers may be used in dealing with spec

19、ific types of cell disrupters (e.g. high pressure homogenizers) which are also used in specific applications such as in dairy industry. The general safety of cell disrupters used in biotechnological processes is covered by EN 292-1, EN 292-2 (see annex B 6, 7) and EN 1672-2. Use of this European Sta

20、ndard will aid the equipment manufacturer in the classification with regard to biosafety performance of cell disrupters in biotechnological processes. The classification is easily understandable and readily utilizable for the user and the regulatory authorities. 1 Scope This European Standard specif

21、ies performance criteria for cell disrupters used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous micr

22、oorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. 2 Normative references This European Standard incorporates by dated or undated references, provisions from other publications. These normat

23、ive references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revision of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated referen

24、ces the latest edition of the publication referred to applies. EN 1672-2, Food processing machinery Basic concepts Part 2: Hygiene requirements. EN 12296, Biotechnology Equipment Guidance on testing procedures for cleanability. EN 12297, Biotechnology Equipment Guidance on testing procedures for ste

25、rilizability. EN 12298, Biotechnology Equipment Guidance on testing procedures for leaktightness. EN 12460, Biotechnology Large-scale process and production Guidance on equipment selection and installation in accordance with the biological risk. EN ISO 4287, Geometrical Product Specifications (GPS)

26、Surface texture: Profile method Terms, definitions and surface texture parameters. (ISO 4287:1997) EN ISO 4288, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and Procedures for the assessment of surface texture. (ISO 4288:1996) 3 Definitions For the purposes of this

27、standard, the following definitions apply. 3.1 cell disrupter equipment used in breakage and/or reduction of size of viable and non-viable microorganisms 3.2 clean condition of (a) product, surface, device, gases and/or liquids with residual soil below a defined threshold value 3.3 cleanability abil

28、ity to be made clean 3.4 hazard intrinsic property or ability of something (e.g. any agent, equipment, material or process) to cause harm EN1620 NOTE Harm is an injury or damage to health of people and/or to the environment. 3.5 leakage egress from equipment 3.6 leaktightness ability of component of

29、 equipment or unit of equipment to limit egress 3.7 microorganism any microbiological entity, cellular or non cellular, capable of replication or of transferring genetic material EN1619 NOTE For the purposes of this standard, the term microorganism covers the term of biological agent, according to t

30、he 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. 3.8 process microorganism microorganism used for production purposes in a biotechnological process or

31、constituting (part of) the product itselfPage 4 EN 12885:1999 BSI 06-1999 * Use of BATNEEC does not mean that financial issues moderate the degree of safety. Where several methods are available, the user can choose the most convenient, provided that it gives results of the necessary quality. 3.9 ris

32、k combination of the probability and the degree of the possible injury or damage to health in a hazardous situation EN 1070 3.10 soil any unwanted matter (including product residues, microorganisms, dust and debris) ISO/CD 14159 3.11 sterile state of being free from viable microorganisms NOTE 1 In p

33、ractice no such absolute statement regarding the absence of viable microorganisms can be proven. However, sterile conditions can be regarded as established by using an accepted or recognized method of sterilization. NOTE 2 The process of inactivation of viable microorganisms during a sterilization p

34、rocedure is usually described by an empirical mathematical function, commonly an exponential function. By their mathematical nature, such functions can be reduced to very low numbers, but not to zero. However, these empirical functions can be applied to control or assess the process parameters of a

35、sterilization procedure to realize a desired degree of inactivation of viable microorganisms. 3.12 sterilizability ability of components of equipment, units of equipment or process plants to be made sterile 3.13 sterilization process used to reach a sterile state 3.14 target microorganism process mi

36、croorganism and/or other microorganisms relevant for a specific process NOTE For safety testing procedures, non-pathogenic microorganisms should be used where possible. 4 Hazards The following hazards shall be taken into account: release of microorganisms by leakage during operation; release of micr

37、oorganisms after operation due to insufficient inactivation and/or removal of microorganisms when the cell disrupter is opened or dismantled; release of microorganisms due to partial or complete seal breakage due to inappropriate operation of the cell disrupter, e.g. dry operation of high-pressure-h

38、omogenizers; release of microorganisms due to pressure build-up by clogging, overloading or inappropriate opening of the cell disrupter. NOTE Leakage occurs as liquid, slurry or aerosol. Given the nature of the function of cell disrupters, it is likely that any leakage will contain both viable micro

39、organisms and non-viable microorganisms. 5 Performance classes 5.1 General The cell disrupter shall be classified for the following performance criteria with regard to the contained use of microorganisms: leaktightness; cleanability; sterilizability. The performance of the cell disrupter shall be de

40、termined separately for each of these criteria in accordance with Tables 1, 2 and 3. NOTE A cell disrupter can for example be in class SI-A for sterilizability, but in class LI-C for leaktightness. 5.2 Leaktightness The performance classes for leaktightness of the cell disrupter are given in Table 1

41、. Table 1 Leaktightness performance Performance class for leaktightness Leaktightness Index (LI) Description of performance class LI-A leakage of target microorganism not defined LI-B leakage 1) of target microorganism detected and quantified under defined conditions LI-C leakage 1) of target microo

42、rganism tested under defined conditions and leakage below detection limit or threshold value 2) 1) Based on leakage assessment by BATNEEC (Best Available Techniques Not Entailing Excessive Costs) * . 2) Prescribed threshold value should be based on the required safety level and can for example be th

43、e detection limit of an approved BATNEEC.Page 5 EN 12885:1999 BSI 06-1999 * Use of BATNEEC does not mean that financial issues moderate the degree of safety. Where several methods are available, the user can choose the most convenient, provided that it gives results of the necessary quality. 5.3 Cle

44、anability The performance classes for cleanability of the cell disrupter are given in Table 2. Table 2 Cleanability performance Performance class for cleanability Cleanability Index (CI) Description of performance class CI-A visible soil or cleanliness not defined CI-B cleanability 1) tested and qua

45、ntified under defined conditions or designed with regard to specified technical criteria CI-C cleanability 1) tested under defined conditions and soil below detection limit or threshold value 2) 1) Based on assessment by BATNEEC (Best Available Techniques Not Entailing Excessive Costs) * . 2) Prescr

46、ibed threshold value should be based on the required safety level and can for example be the detection limit of an approved BATNEEC. NOTE Cleanability applies as a performance criterion for the cell disrupter where: deposits of soil in the cell disrupter could jeopardize the sterilization procedure

47、if the sterilization media do not reach all parts of the cell disrupter or if the required temperature is not reached; cleaning procedures are intended to remove and inactivate microorganisms to make the cell disrupter safe for handling without using any other sterilization or inactivation procedure

48、. 5.4 Sterilizability The performance classes for sterilizability of the cell disrupter are given in Table 3. Table 3 Sterilizability performance Performance class for sterilizability Sterilizability Index (SI) Description of performance class SI-A cell disrupter not suitable or not tested for reduc

49、tion of viable target microorganisms SI-B cell disrupter can be treated for a specified reduction of viable target microorganisms SI-C cell disrupter can be sterilized NOTE In this table the result (performance) of an inactivation procedure is described and not the way or means of achieving the result. 5.5 Use of performance classes in equipment selection The selection of the appropriate class for performance of a cell disrupter in a biotechnological process shall be made in accordance wi