EN 12885-1999 en Biotechnology - Performance Criteria for Cell Disrupters《生物技术 细胞裂解仪性能标准》.pdf

1、 STD*BSI BS EN 22885-ENGL 1777 D lb24bb9 0781782 T79 D BRITISH STANDARD Biotechnology - Performance criteria for cell disrupters The European standard EN 12W1999 has the status of a British standard ICs 07.080 BS EN 12885: 1999 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW S

2、TD-BSI BS EN 32885-ENGL 1979 = Lb24bb9 0783783 905 = been prepared under the direction of the Sector Committee for Materiais and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 June 1999 Amd. No. I 0 BSI 06-1999 ISBN O 680 32272 6 BS EN 12885:1999

3、Date Comments National foreword This British Standard is the English language version of EN 12885:1999. The UK participation in its prepamtion was entrustd to Technical Committee CII/58, Biotechnology, which has the resP0nsi;bility to: - aid enquirers to understand the text; - present to the respons

4、ible European committee any enquiries on the - monitor related intemational and European developments and promulgate interpretalion, or proposals for change, and keep the UK interests informed; them in the UIC A list of organizations represented on this committee can be obtained on request to its se

5、cretary. Cross-references The British Standards which implement inkrnatiod or European pubiidons referred to in this document may be found in the BSI Standards Catalogue under the section entitied “Intedonai Standarcis Correspondence Index“, or by using the “Find“ faciity of the BSI Standards Electr

6、onic Catalogue. A British Standard does not pwport to include ail 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 docum

7、ent comprises a front cover, an inside front cover, the EN title page, pages 2 to 7 and a back cover. STD-BSI BS EN 12885-ENGL 1797 lb24bb7 078L78i dil EUROPEAN STANDARD EN 12885 NORME EuROPEE”E EUROPhKHE NORM February 1999 ICs 07.080,07.100.01 Descripbm biotechnology, material, cells iology), safet

8、y, hazards, environmentai protection, accident prevention, contamination, microorganisms, denitions, ciassifications, characteristics, leaktightness, cleaning, sterization, verifcation, tests, markmg, packing English veision Biotechnology - Performance aiteria for cell clsruptem Biotechnologie - Git

9、m de performance pour les Biotechnik - Leistungskriterien nir broyeurs de ceiiuies ZelhfsChlage This European Standard was approved by CEN on 28 January 1999. CEN membem are bound to compiy with the CEN/CENELEC Internal Regdations which stipuiate the conditions for giving this European Standard the

10、status of a nationai standard without any aiteration. Up-bdate lists and bibliographicai references concerning such nationai standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three officiai versions CEngliSh, French, German). A

11、 version in any other ianguage made by translation under the responsiblity of a CEN members into its own ianguage and noed to the Central Secretariat has the same status as the officiai versions. CEN members are the nationai standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, Fra

12、nce, Germany, Greece, Iceland, irehd, Italy, Luxembourg, Netherlands, Norwax Porhigal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Stan- on ComitP: Europen de Normalisaton Europisches Komitee fr Normung Centrai Secretariat: rue de Stassart 36, B-1060 Brussels O 1999 CEN

13、 Ali rights of exploitation in any form and by any means reserved woridwide for CEN national Members. Ref. No. EN 12W1999 E Page 2 EN 12885:1999 Foreword This European Standard has been prepared by Technicd Committee CEN/IY= 233 “Biotechnology“, the Secretariat of which is held by AFNOR. This Europe

14、an standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 1999, and conflicting national standards shali be withdrawn at the latest by August 1999. This draft European Standard has been prepared under a manchte

15、 given to CEN by the European Commission and the European Free We Association. According to the CENKENELEC hted Reguiations, the nationai standards organi - release of microorganisms after opedon due to insufficient inadivation andor removal of microorganims when the cell disrupter is opened or dism

16、antled; - release of microorganisms due to parihi or complete seai breakage due to inappropriate operation of the cell jsrupter, e.g. dry operation of high-pressurehomogenizers; - release of microorganism due to pressure build-up by clogging, overloadmg or inappropriate opening of the cell disrupter

17、. NOTE Leakage ocm as liquid, sluny or aerosol. Given the nature of the function of celi disrupters, it is likely that any leakage will contain both viable microorganisms and non-viable Inirganisms. 6 Perfon;nance classes 6.1 General The ceil disrupter shall be cbied for the following performance cr

18、iteria with regard to the contained use of micnorganisms: - leaktightniess; - Cleanabilia -stemi. ”he performance of the cell disnipter shail be determined separately for each of these criteria in accordance with Wles 1,2 and 3. NOTE A cell disrupter can for example be in class SI-A for stdizability

19、, but in class LI4 for leaktightness. 6.2 Leaktightmess The performance classes for leahghtness of the cell -ter are given in Pabe 1. Table 1 - Leaktightness performance Performance class foi leaktightness Leaktightness Inder (LI) LI-A LI-B LI4 Description of performance clam leakage of target micro

20、organism not defined eakagel) of target microorganism detected and quantified under defined conditions eakagel) of target microorganism tested under defined conditions and leakage below detection limit or threshold valu$) Eked on leakage assessment by BATNEEC (Best Available “ques Not Entaiing Exces

21、sive Casts). 2, Prescribed threshold value should be based on the required safety level and can for example be the detection limit of an approved BATNEEC. Use of BATNEEC does not mean that nancial issues moderate the degree of safety. Where several methods are available, the user can choose the most

22、 convenient, provided that it gives results of the necessary quahty. O BSI 06-1999 STD.BS1 BS EN 32885-ENGL 1979 = Lb24hb 0783788 497 Performance class for cleanability Cleanability Index (CI) CI-A CI-B CI4 6.3 Cleanability The performance classes for cleanability of the cell disrupter are given in

23、?Cible 2. Description of performance class visible soil or cleanliness not defined cleanabity1) tested and quantifed under defhed conditions or designed with regard to specifed technical criteria cidilityl) tested under denned conditions and soil below detection limit or threshold valu$) Table 2 - C

24、leanability performance Performance class for Sterizabits index CS sterilizability Description of performance claes NOTE Cleanability applies as a performance criterion for the cell disrupter where: - deposits of soil in the cell disrupter could jeopardize the sterilization procedure if the sterilkd

25、on 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 microorganimris to make the ceil disrupter safe for handling without using any other sterilization or inactivation procedure. 6.4 Steriliza

26、bility The performance classes for steriiizability of the celi disrupter are given in ?Cible 3. SI-B SI-c Table 3 - Sterilizability performance microorganisms ceii disrupter can be treakd for a specified redudon of viable target microorganislns cell isrupter can be sterilized I cell disrupter not su

27、itable or not tested for reduction of viable target Page 6 EN 1288 or - there are only minor changes that do not afect biosafew. If there are oniy minor changes that do not affect biosafew, the manufacturer shall document the changes and shall provide evidence to the user that these changes will not

28、 result in the need for reclassincation. If, for a classified existkg cell disrupter, park or components are replaced by other parts or components of similar performance class, the overail classification of the cell disrupter remains the same. NOTE 2 Verification of classification can for example be

29、 done by operating an appropriate quaiity assurance system (see annex B PI, 91 * 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. O

30、BSI WlW9 STD-BSI BS EN 12885-ENGL 1997 8 Lb24bb9 0781789 323 m Page 6 EN l2885:1999 6.2 Leaktightness The cell disrupter shall be classified LI-A if no tests are executed to determine the leaktightness Ib be ciassiied LI-B or LI-C, the leaktightness of a cell disrupter shall be tested in accordance

31、with EN 12298. An example of the selection of a leaktightness test method is given in annex A. The cell disrupter shall be ciassjfed in LI-B if the test for LIC has resulted in a leakage above threshold value. 6.3 Cleanability The cell disrupter shall be classified CI-A if no tests are executed to d

32、etermine the cleanability or if there is visible soil after a cleaning procedure. Ib be ciassied CI-B or CI-C, the cleanability of a cell disrupter shall be tested in accordance with EN 12%. Aitedvely the cell disrupter can be classified in CI-B if it is designed according to EN 1672-2 and if the su

33、rface roughness of the metallic material applied in the cell disrupter is less than or equal to Ra = 1,6 (dened according to EN IS0 4287 and measured according to EN IS0 4288) on internal product contact areas. NOTE An electrochemical surface trehent of metallic materials is preferable to a mechanic

34、al polish because it produces a smoother surface even if the Ra values are the same. During his type of surface treatment, sharp peak and dey contours will be reduced preferentially because of high current rates at these particular parts. Applicability of electrochemical treatment can depend on the

35、type of material in use. Documentaon containing information about surace roughness for Merent can it be accessed Yes; Can intrusive methods be yes (Le. fluis other than used: process fluid can be used); Quantihiive methods 11 and 15; Semi quantitative methods 8,14 and 16. in accordance with lble Al

36、of EN 12298 the following test methods are selected: Igble A.l - Leaktightness test methods for cei disrupter Number Test method Wer-iiquid dyes Electronic particle counting 14 Quaiitative bioaerosol monitoring 15 Quantitative bioaerml monitoring NOTE in the case of a high pressure ceil disrupter te

37、st methods 11 and 8 will indicate liquid release into the lubrication fluid, but other test methods will not. Based on a hazard analysis appropriate test methods should be chosen in order to cover all sources of release. Page 7 EN 12885:1999 Annex B ( informative) Bibliography i Stewart I.W. and Dea

38、ns J.S., Containment testing of ceil disruptem, WSL Report LR 767 (BT), March 1990, 2 Ferris LE., KeshavarzMoore E., Leaver G., Noble M., lrner M.K., 1995, Microbial popdalion balancing as a quantitative aid for evaiuahng release from a high pressure homogenizer, Ti.ans. IChemE Part B, Process safet

39、y and envimta fn&on, August edition. 3 Nobel M., Feni LE., ker M.K., KeshavamMoore E., 1995, A polymerase chain reaction method for the selective measurement of genetically modified microorganisms release from bioprocess, Pm. 1- Reseamh Event, Jan 1995, Edinburgh, p. 905 - 907. 4 Bennet AM., 1991, B

40、ide integrity testing of the CSL cell dismpter CAMR Report. 6 FOSTER, D., 1992, Cell Dismptiom breaking up is 6 EN 292-1, Safety of muchinmy - Basic concepts, geneml pincph for design -Part 1: hic 7 EN 292-2, Safety of machineq - Basic cmepts, geneml pinciph for design - Part 2: Technical principles

41、 and sp&xxtions. assumme in design, development, product.ion, instauation and sWw. 9 EN IS0 9002, Quality systems -Model for quality assurance in production, installation and s&w. lo EN 1070, safety of muchimy - Termirwlogg li EN 1619, Bwtechnobgy - Large-scale pnxess and and organization for stmin

42、consemxltion pmcedum. 12) EN 1620, Biotechmiogy - Large-scale pmcess and production - Plant building amding to the degree of hazami. 131 ISOKD 14159, Safety of machinery - Hygiene requirements for the &sign of machinery. 141 Council Directive 90/219/EEC of 23 April 1990 on the contained use of genet

43、ically modined microorganisms. OJEC 08.05.1990, no. L 117 p 1. 151 Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks relatai to exposure to biologica agents at work (seventh individual Directive within the meaning of Mcle 16 (1) of Directive 89B9VEEC). OJEC 31.

44、12.1990, no. L 374 p 1. AEA zI?chPublicatiolzs, culham, oxfordshire, UK. hard to do, Biotechnology 10, p. 1539 - 1641. t4?rminolOgy, met hoc lob 8 EN IS0 9001, &wllity ystems - Mdel fW quality (Is0 9001:1994) (Is0 9002: 1994) product.ion - Geneml requirements formanugement O BSI 06-1999 BS EN 12885:

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