1、 STD-BSI BS EN L309L-ENGL 2000 Lb24664 0835337 319 BRITISH STANDARD Biotechnology - Performance criteria for filter elements and filtration assemblies The European Standard EN 13091:1999 has the status of a British Standard ICs 07.080; 07.100.01 BS EN 13091:ZOOO NO COPYING WITHOLT BSI PERMISSION EXC
2、EPT AS PERMITTED BY COPYRIGHT LAW STDSBSI BS EN L309L-ENGL 2000 Lb24bb9 0835338 255 BS EN 13091:2000 been prepared under the direction of the Sector Amd. No. Date Commime for Materiais and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 March 2000
3、O BSI 03-2 National foreword Comments This British Standard is the official English language version of EN 13091:1999. The UK participation in its preparation was entrusted to Technical Committee W58, Biotechnology, which has the responsibility to: - aid enquirers to understand the text; - present t
4、o the responsible European committee any enquiries on the - monitor related intedonal and European developments and promulgate interpretation, or proposals for change, and keep the UK interests mformed; them in the UK. A list of organizations represented on this committee can be obtained on request
5、to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitied “Intemational Standards Correspondence Index”, or by using the “Find” facility of the BS
6、I Standards Electronic Catalogue. A British Standard does not purport to include all 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
7、 of pages This document comprises a front cover, an inside front cover, the EN titie page, pages 2 to 19 and a back cover. The BSI copynght notice displayed in this document indicates when the document was last issued. ISBN O 580 35457 1 - STD-BSI BS EN 13091-ENGL 2000 m 1b24bb9 0835339 191 m EUROPE
8、AN STANDARD EN 13091 NORME EUROPENNE EUROPISCHE NORM December 1999 ICs 07.080; 07.100.01 English version Biotechnology - Performance criteria for filter elements and filtration assemblies Biotechnologie - Criteres de performance pour les lments filtrants et les filtres Biotechnik - Leistungskriterie
9、n fr Filterelemente und Filtrationseinrichtungen This European Standard was approved by CEN on 25 September 1999. CEN members are bound to comply with the CENICENELEC Internal Regulations which stipulate the conditions for giving this Europem Standard the status of a national standard without any al
10、teration. Up-to-date lists and bibliographical references concerning sich 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 tra
11、islation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as he official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,
12、 Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION EUROPISCHES KOMITEE FR NORMUNG COMIT EUROPEN DE NORMALISATION Central Secretariat: rue de Stassart, 36 B-1050 Brussels O 1999 CEN All rights of exploitation in any
13、 form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13091:1999 E . Page 2 EN 13091:1999 Contents Foreword . . 3 Introduction - 4 1 Scope .- 4 2 Normative references 4 3 Terms and definitions . - . 5 4 Hazards . 9 5 Performance classes . .) . 10 6 Classification and verifi
14、cation of performance . 13 7 Marking and packaging . 15 8 Documentation . 15 Annex A (informative) Guidance on test methods . 16 Bibliography -. 18 STD-BSI BS EN 13091-ENGL 2000 = 1624b69 0835341 84T Page 3 EN 13091:1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC
15、 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 May 2000, and conflicting national standards shall be withdrawn at the latest by May
16、 2000. According to the CENICENELEC 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, Norw
17、ay, Portugal, Spain, Sweden, Switzerland and the United Kingdom. OBSI 03-2000 Page 4 EN 13091 : 1999 Introduction Filter elements by nature are not intended to prevent the passage of fluids, but to remove or reduce the microorganism load to acceptable levels, by retention of the target microorganism
18、s within the filter medium. Leaktightness in this context refers to the ability of the filtration assembly to retain the target microorganism. Use of this European Standard will aid the equipment manufacturer in the classification of filter elements and filtration assemblies with regard to biosafety
19、 performance in biotechnological processes. The classification is easily understandable and readily utilizable for the user and the competent authorities. I Scope This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes wi
20、th respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or wh
21、ere exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. This European Standard applies to sterilizability and cleanability of filter assemblies and to leakage of microorganisms through the housing of a filtration assembly and to leakage of microorgan
22、isms through filter elements for dead-end filtration and cross-flow filtration. This European Standard does not apply to filter elements and filtration assemblies used to avoid contamination of bioreactors, for example by sterilizing inlet air or feedstream. 2 Normative references This European Stan
23、dard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to
24、 this European Standard only when incorporated in it by amendment or revision. For undated references 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 testin
25、g procedures for cleanability EN 12297 Biotechnology - Equipment - Guidance on testing procedures for sterilizability EN 12298 Biotechnology - Equipment - Guidance on testing procedures for leaktig ht ness OBSI 03-2000 STD-BSI BS EN L307L-ENGL 2000 Lb24bb9 0835343 bB2 m Page 5 EN 13091:1999 EN 12460
26、 Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk EN IS0 4287 Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters (IS0 4287:1997) EN
27、IS0 4288 Geometrical Product Specifications (GPS) - Surface texture: Profile method - Rules and Procedures for the assessment of surface texture (IS0 4288: 1 996) 3 Terms and definitions For the purposes of this standard, the following definitions apply. 3.1 arithmetical mean deviation of the profil
28、e (Ra) the arithmetical mean of the absolute values of the profile departures within the sampling length EN IS0 42871 3.2 cartridge disposable filter element 3.3 cross-flow filtration filtration characterized by a flow alongside the filter medium surface (retentate) and a flow crossing the filter me
29、dium (permeate) NOTE Examples of cross-flow filtration are reversed osmosis, dialysis, microfiltration, ultrafiltration and nanofiltration. 3.4 cut-off smallest particle size or molecular weight components retained at a given reduction efficiency 3.5 dead-end filtration filtration characterized by a
30、 feed forced through the filter medium depositing retentate in or on the filter medium NOTE Examples of dead-end filtration are filtration by means of sand filters, wounded cartridges, high efficiency particulate air (HEPA) filters, sintered glass filters and sterilizing membrane cartridges. OBSI 03
31、-2000 STD-BSI BS EN 23091-ENGL 2000 2624667 0835344 559 Page 6 EN 13091:1999 3.6 direct test method (in biotechnology) test method which employs microorganisms for quantification 3.7 feed incoming fluid 3.8 filtration assembly filter element mounted into a filter housing NOTE 1 A filtration assembly
32、 is sometimes called a module. NOTE 2 The filter housing can include for example valves,pumps, couplings and monitoring devices that enable a filtration operation. NOTE 3 An example of how a filter assembly is made up of a filter element and filter housing is given in figure 1. 4 1= 2= 3= 1+2 = 1+2+
33、3 = Filter medium Supporting construction Filter housing Filter element Filtration assembly Figure 1- Example of a filtration assembly 3.9 filter element combination of a filter medium and its supporting construction NOTE A filtration assembly will normally consist of several filter elements. The fi
34、rst filter element (prefilter element) will retain the bulk of the particles in the gas- or liquid in order to give the final filter element(s) a longer lifetime. The prefilter elements will usually have a lower reduction efficiency than the final filter element(s). OBSI 03-2000 STD-BSI BS EN 13OEIL
35、-ENGL 2000 M Lb24bb9 0835345 495 Page 7 EN 13091:1999 3.10 filter medium physical barrier consisting of a membrane or any porous material 3.1 1 filtrate; permeate part of the feed passing through the filter medium 3.12 fi It ra ti on separation technique using a filter medium NOTE Filtration can be
36、done in dead-end operating mode or in cross-flow operating mode. 3.1 3 hazard intrinsic property or ability of something (e.g. agent, equipment, material or process) to cause harm EN 16201 NOTE Harm is an injury or damage to health of people and/or the environment. 3.14 indirect test method (in biot
37、echnology) test method which employs physical and/or chemical means for quantification 3.15 integrity test test to verify conformity with respect to specifications of the filter element characteristics NOTE An integrity test for a filter element usually refers to a non-destructive indirect test for
38、assessment of for example the retention rate. 3.16 leakage egress from equipment 3.17 loglo reduction value (L,) logarithm to the base I O of the ratio of the concentration of target microorganisms in the feed and the concentration of target microorganisms in the permeate, expressed as: Cf L, =loglo
39、 - CP OBSI 03-2000 STDmBSI BS EN 13091-ENGL 2000 1b24bb9 O83534b 321 Page 8 EN 13091:1999 where: Cr is the concentration of target microorganisms in the feed, expressed in numbers per millilitre; C, is the concentration of target microorganisms in the permeate, expressed in numbers per millilitre NO
40、TE 1 Sometimes the term titer reduction value Tr is used instead of L,. NOTE 2 loglo reduction values of the filter elements in filtration assemblies can be added in order to get the total loglo reduction value. 3.18 membrane barrier separating retentate and permeate 3.19 microorganism any microbiol
41、ogical entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 161 91 NOTE For the purposes of this standard, the term microorganism covers the term of biological agent, according to the Directive 90/679/EEC: microorganisms, including those which have been gen
42、etically modified, cell cultures and human endoparasites which can be able to provoke any infection, allergy or toxicity. 3.20 process microorganism microorganism used for production purposes in a biotechnological process or constituting (part of) the product itself 3.21 reduction efficiency efficie
43、ncy of a device (for example a filter element) to decrease the number of viable microorganisms passing it measured by the loglo reduction value , NOTE In practice the term removal efficiency is also used. 3.22 retentate part of the feed not passing through the filter medium OBSI 03-2000 STD-BSI BS E
44、N 13091-ENGL 2000 1624669 0835347 268 Page 9 EN 13091:1999 3.23 risk a combination of the probability and the degree of the possible injury or damage to health in a hazardous situation EN 10701 3.24 soil any unwanted matter (including product residues, microorganisms, dust and debris) ISO/CD 141 591
45、 3.25 sterile state of being free from viable microorganisms NOTE 1 In practice 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 p
46、rocess of inactivation of viable microorganisms during a sterilization procedure 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 fu
47、nctions can be applied to control or assess the process parameters of a sterilization procedure to realize a desired degree of inactivation of viable microorganisms. 3.26 steriliza bility ability of components of equipment, units of equipment or plants to be made sterile 3.27 sterilization process u
48、sed to reach a sterile state 3.28 target microorganism process microorganism and/or other microorganisms relevant for a specific process NOTE For safety testing procedures, non-pathogenic microorganisms should be used where possi ble. 4 Hazards The following hazards shall be taken into account: - re
49、lease of microorganisms by leakage through a malfunctioning filter OBSI 03-2000 Page 10 EN 13091 : 1999 - release of microorganisms by leakage through the connections between the filter element and the filter housing; - release of microorganisms by leakage through the connections between the filter housing and adjacent components (for example piping and couplings); - release of microorganisms after operation due to insufficient inactivation and/or removal of microorganisms when the filtration assembly is opened or dismantled. 5 Performance classes
