1、BRITISH STANDARD Biotechnology - Performance criteria for centrifuges The European Standard EN 12884: 1999 has the status of a British Standard ICs 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 12884:1999 - - STD=BSI BS EN 12884-ENGL 1999 m IbZ4bb9 0778945 3Tb m
2、 been prepared under the direction of the Sector Amd.No. Date Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 10 June 1999 O BSI O-1999 ISBN O 580 32271 8 BS EN 128W1999 Comments National foreword This British Standard is t
3、he English language version of EN 12W1999. The UK participation in its preparation was entrusted to Technical Cornmittee CW58, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible European committee any enquiries on the - monitor relate
4、d international and European developments and promulgate interpretation, or proposals for change, and keep the UK interests informed; them in the UK A lict of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which impleme
5、nt international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entited ?International Standards Correspondence Index?, or by using the ?Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport t
6、o include all the necessasy 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 document comprises a front cover, an inside front cover,
7、 the EN title page, pages 2 to 8, an inside back cover and a back cover. STD.BSI BS EN 22884-ENGL 2779 H LbZLibb9 077874b 232 m EUROPEIN STANDARD NORM3 EUROPENNE EUROP - release of microorganisms after operation due to insuffcient inactivation andlor removal of microorganisms when the centrifuge is
8、opened or dismantled. 5 Performance classes 5.1 General The centrifuge shali be classified for the following performance criteria with regard to the contained use of microorganisms: - leaktightmess; - cleanability; - sterilizability. The performance of the centrifuge shali be determined separately f
9、or each of these criteria in accordance wih Tables 1,2 and 3. NOTE A centrifuge can for example be in class SL4 for sterilizability, but in class LI-C for leaktightness. O BSI O81999 STD.BSI BS EN 12884-ENGL 1977 LbZIbb7 0778950 7b3 Performance class for leaktightness Leaktightness Index (LI) LI-A L
10、I-B LI-C Description of performance class leakage of target microorganism not defined leakage11 of target microorganism detected and quantified under defined conditions leakage) of target microorganism tested under defined conditions and leakage below detection limit or threshold vaJu$) 5.3 Cleanabi
11、lity The performance classes for cleanability of the centrifuge are given in Table 2. Table 2 - Cleanability performance for cleanability Cleanability Index CI-A visible soil or cleanliness not defined Performance class for sterilizability Sterilizability Index (SI) SI-A CI-B Description of performa
12、nce class centrifuge not suitable or not tested for reduction of viable target microorganisms cleanability) tested and quantified under defined conditions or designed with regard to specified technical criteria SI-C CI-c centrifuge can be sterilized cleanability) tested under defined conditions and
13、soil below detection limit or threshold value 2) i) Based on 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 the detection limit of an Page 5 EN 12884:1999 SI-B centrif
14、uge can be treated for a specified reduction of viable target microorganisms 5.5 Use of performance classes in equipment selection The selection of the appropriate class for performance of a centrifuge in a biotechnological process shall be made in accordance with the risk analysis as described in E
15、N 12460. NOTE In practice the following has been found to be suitable for guidance for the usage of classes given in Tables 1,2 and 3. If the release of microorganisms is to be minimized, a centrifuge can be used which is classified SI-B, CI-A and LI-B or better. If the release of microorganisms is
16、to be prevented, a centrifuge can be used which is classified SI-C, CI-B and LI-C or better. If these performance classes are not used as described or are considered to be inappropriate, alternative and/or additional measures are necessary e.g. procedural measures, secondary containment or disposabl
17、e equipment. * Use of BATNEEC doed 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 qualis. O BSI 06-1999 STD-BSI BS EN 12884-ENGL L777 Lb24bb7 0778753 bTT Page
18、6 EN 128849999 6 Classification and verification of performance 6.1 General Centrifuges covered by this European Standard shall be classified in accordance with Tables 1,2 and 3. The performance of centrifuges is determined and verified by the manufacturer or by the user. NOTE 1 Under certain circum
19、stances the user can reclassify the centrifuge. if for example the centrifuge could comply with steriiizability class SI-C but is classified SI-B because the manufacturer has done only a simple test, then the user can reclassify the centrifuge to SI-C if he executes and documents the appropriate tes
20、ts. Tests shall be performed under representative process conditions. To be classied according to this European Standard the centrifuge shall be designed according to EN 2921 If centrifuges are manufactured in accordance with an already classified prototype they are classified in the same class as t
21、he prototype, if: ad -2 and EN 12547. - there is no change in design or materials used or - there are only minor changes that do not affect biosafew. EXAMPLE It is not to be expected that changes in the drum design will have an effect on leakage from the casing. If there are only minor changes that
22、do not affect biosafew, the manufacturer shall document the changes and shall provide evidence to the user that these changes will not result in the need for reclassification. If, for a classified existing centrifuge, parts or components are replaced by other parts or components of similar performan
23、ce class, the overall classification of the centrifuge remains the same. NOTE 2 Verification of classification can for example be done by operating an appropriate qualis assurance system (see annex A FI, 71). The test report shall clearly state the boundaries of the tested object. NOTE 3 Tests may c
24、oncern a centrifuge without any auxiliary equipment or a centrifuge including all the auxiliary equipment needed to run the centrifuge. In practice it can be difficult or impossible to test for example sterilization for a centrifuge with no auxiliary equipment as the effectiveness of the sterilizati
25、on procedure can depend on for example the size, type and position of the auxiliary equipment. 6.2 Leaktightness The centrifuge shall be classified LI-A if no tests are executed to determine the leaktightness. To be classified LI-B or LI-C, the leaktighness of a centrifuge shall be tested in accorda
26、nce with EN 12298. The centrifuge shall be classified in LI-B if the test for U4 has resulted in a leakage above threshold value. An alternative way for classification into clacs LI-B for a centrifuge that is designed to operate in a closed system is to measure the gas leakage rate by the tirned pre
27、ssure drop method in accordance with EN 12298. The test pressure shall be the same as the normal operating pressure. If this is atmospheric pressure then the test shall be done at 4 kPa gauge pressure. The temperature shall be ambient and the test time shall be one hour. The test can be done with th
28、e rotor standing sti. The minimum requirement is that gauge pressure shall not drop more than 15 % during this time. NOTE 1 The requirements above are a minimum that. can be insufficient in many cases. For a centrifuge with a gaq v$iiint of e.g. 100 1 this corresponds to a leakage rate of 17 nia.ni%
29、 or a standardized leakage rate of SLR = 204 mPa.ni.%. The detcction limit with this method depends mainly on how ronstant the temperature can be kept during the test. If the uncertainty in temperature is f 0,5 K this corresponds to a possible pressure decrease of 9 % which means that this classific
30、ation method can not be used if the requirements are high. For centrifuges that have a shaft seal that precludes such a pressure drop test (e.g. gas barrier seal), the test can be done for casing only without the rotor fitted and the opening for the shaft blocked. In such cases the shaft seal shall
31、be classified separately according to EN 12690. In any case where the containment can be broken if the supply of some service media to the centrifuge fails, this shall be clearly stated in the documentation for use. Other methods to get a quantitative measurement of the gas leakage rate can also be
32、used for classification into class LI-B. Guidance of such methods are given in EN 12298 and prEN 1779 (see annex A 4). The measured leakage rate shall not be higher than the calculated leakage rate for a pressure drop of 15 96 in gauge pressure at the conditions given above. NOTE 2 The leakage of mi
33、croorganisms is not always rela(cd to the gas leakage rate. NOTE 3 Test methods with biological, chemical or physical indicators can also be used for classification into class LI-C: provided a validated correlation exists between such tests and tests with inoculation of a mobile microorganism. 6.3 C
34、leanability The centrifuge shall be classified CI-A if no tests are executed to determine the cleanability or if there is visible soil after a cleaning procedure. To be Classified CI-B or CI-C, the cleanability of a centrifuge shall be tested in accordance with EN 12296. Alternatively the centrifuge
35、 can be classified in CI-B if it is designed according to EN 1672-2 and if the surface roughness of the rneta.Uk material applied in the centrifuge is less than or equal to Ra = 1,6 pm (defined according to EN IS0 4287 and measured according to EN IS0 4288) on internal product contact areas. NOTE 1
36、An electrochemical surface treatment of metallic materials is preferable to a mechanical polish because it produces a smoother surface even if the Ra values are the same. During this type of surface treatment, sharp peak and valley contours will he reduced preferentially because of high current rate
37、s at these particular parts. Applicability of electrochemical treai.nient can depend on the type of material in use. O BSI 06-1999 Documentation containing information about surface roughness for different surfaces and drawings showing how well the design conforms to EN 1672-2 shall be included. Dev
38、iations from the design requirements above shall be pointed out and the reasons for the deviations shall be explained. NOTE 2 A low surface roughness on surfaces where soil is pressed to the surface by high centrifugal force gives no assurance that the cleaning result will be good. Other design crit
39、eria such as e.g. the angle between the rotation axis and the surface can be more important. The composition of the media has also a large influence on the cleaning. When a certain microorganism is harvested, the cleaning can be in class CI-C if the microorganism is grown in molasses. Another parame
40、ter that has a high influence on the cleaning result is how long time the soil has been pressed against the surface. NOTE 3 A centrifuge that has to be opened for cleaning is always classified into class CI-A. NOTE 4 Test methods with biological, chemical or physical indicators can also be used for
41、classification into class CI-C provided a validated correlation exists between such tests and tests with inoculation of a motile microorganism. 6.4 Sterilizability The centrifuge shall be classified SI-A if no tests are executed to determine the sterilizabiliQ. To be classified SI-B or SI-C, the ste
42、rilizability of a centrifuge shall be tested in accordance with EN 12297. The inactivation or sterilization procedure shall be in accordance with the manufacturers recommendations. An alternative way for classification into class SI-B is to venfy the sterilization procedure with biological, chemical
43、 or physical indicators. The indicators shall be placed at various positions inside the drum and casing. The test report shall specify the properties of the indicators, how they have been positioned and the result for each indicator. NOTE Test methods with biological, chemical or physical indicators
44、 can also be used for classification into class SI-C provided a validated correlation exists between such tests and tests with inoculation of a motile microorganism. Page 7 EN 12884:19!39 7 Marking and packaging Each centrifuge shall be marked in such a way that its performance with regard to cleamb
45、iiQ, sterilizabiity, leaktightness can be verified If it is not practical to mark a centrifuge or a component of the centnfuge (e.g. due to its size or nature) the packaging shall be marked. An unmarked centrifuge or package sha be classified LI-A, SI-A NOTE This marhg could be for example trade mar
46、k, type number, year of production. and CI-A. 8 Documentation The manufacturer or supplier shd provide the documentation required by EN 12547. The manufacturer or supplier shall provide a written manual which details the operating procedures which enable the centrifuges to perform in accordance with
47、 its specified classification for cleanabiiity, steriizabiiity and leaktighlness. The user shall keep documentation which demonstrates the current perfomce of the centrifuge and its verification. O BSI 06-1999 STD=BSI BS EN L2884-ENGL L777 II Lb24bb9 0778953 472 Page 8 EN 12884:1999 Annex A (informa
48、tive) Bibliography 11 Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms. OJEC 08.05.1990, no. L 117 p 1. 2 Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work
49、 (seventh individuai Directive within the meaning of Article 16 (1) of Directive 99iEEC). OJEC 31.12.1990, no. L 374 p 1. 3 EN 6262, Safety of mach2nly - Reduction of risk to health fm hazardous substama emitted by machinery - Part 2: Methodology leading to verifkation pcedures. 4 prEN 1779, Non-destructive testing - Leak testing - Guide to the method selection. (51 EN 61010-2420, Safety requirements for electrical equipment for masurement, control a,nd laboratory use - Part 2-020: Particular requirements for laboratmy centrifuga. 6 EN IS0 9001, Quality s
