EN 13092-1999 en Biotechnology - Equipment - Guidance on Sampling and Inoculation Procedures《生物技术 设备 采样和接种方法指南》.pdf

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1、 STDmBSI BS EN L3092-ENGL 2000 Lb24669 0835357 TBT BRITISH STANDARD Biotechnology - Guidance on sampling and inoculation procedures The European Standard EN 13092:1!399 has the status of a British Sandard ICs 07.080; 07.100.01 BS EN 13092:2000 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY

2、 COPYRIGHT LAW STDaBSI BS EN 13092-ENGL 2000 = Lb24bb9 08353b0 7TL W BS EN 13092:2000 direction of the Sector Amd. No. Date Committee for Materiais and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 March 2000 O ES1 03-2000 National foreword Comme

3、nts This British Standard is the official English language version of EN 13092:1999. The TJK participation in its preparation was entrusted to Technical Committee CW58, Biotechnology, which has the responsibility to: - aid enquires to understand the text; - present to the responsible European commit

4、tee any enquiries on the - monitor related international and European developments and promulgate interpretation, or proposals for change, and keep the UK interests donned; them in the UK. A list of organhiions represented on this committee can be obtained on request to its secretary. Cross-referenc

5、es The British Standards which implement intemational or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entided “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue.

6、 A British Standard does not purport 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 document comprises

7、 a front cover, an inside front cover, the EN title page, pages 2 to 15 and a back cover. The BSI copynght notice displayed in this document ini- when the document was last issued. ISBN O 580 35458 X I I STD=BSI BS EN L3092-ENGL 2000 Lb2Ybb9 0835363 b38 = EUROPEAN STANDARD EN 13092 NORME EUROPENNE E

8、UROPISCHE NORM December 1999 ICs 07.080; 07.100.01 English version Biotechnology - Equipment - Guidance on sampling and inoculation procedures Biotechnologie - Equipement - Guide de procdures pour lchantillonnage et linoculation Biotechnik - Gerte und Ausrstungen - Leitfaden fr Probenahme- und Beimp

9、fungsverfahren 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bi

10、bliographical references 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 traslation under the responsibility

11、of a CEN member into its own language and notified to the Central Secretariat has the same status as tie official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands,

12、Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMIlTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-IO50 Brussels O 1999 CEN All rights of exploitation in any form and by any means reserved w

13、orldwide for CEN national Members. Ref. No. EN 13092:1999 E OBSI 04-2000 STD-BSI BS Page 2 EN 13092: 1999 Contents EN 13092-ENGL 2000 Lb2Lihh9 08353b2 57Li = Page Foreword . 3 Introduction . 4 Scope 4 Normative references 5 Terms and definitions . 5 Hazards 8 Methodology for preparation of a safe op

14、erational procedure . 9 Documentation 11 Annex A (informative) Examples to illustrate procedure for compliance . 12 Bibliography 15 8BSI 03-2000 STD*BSI BS EN L3092-ENGL 2000 Lb24bb9 0835363 400 Page 3 EN 13092: 1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC 233

15、, 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 June 2000, and conflicting national standards shall be withdrawn at the latest by June 2

16、000. According to the CENKENELEC 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, Norway,

17、 Portugal, Spain, Sweden, Switzerland and the United Kingdom. OBSI 03-2000 Page 4 EN 13092: I999 Introduction This European Standard provides a framework to ensure that sampling and inoculation procedures meet workplace and environmental safety requirements with respect to microorganisms. Such proce

18、dures may need to be carried out in parallel with other requirements such as prevention of process contamination. Samples from a biotechnological process often need to be taken for off-line analysis, thus breaching the integrity of a closed system. The most common example is taking samples to monito

19、r the status of the process or to verify the specifications of the product. In a comparable way the integrity is breached when an inoculum is introduced into a closed system from the outside. Both situations have potential for release of microorganisms into the environment. Selection of appropriate

20、sampling and inoculation devices is one factor in the overall safety. In this respect, well designed and manufactured sampling and inoculation devices are most important factors to safety. However, the operation and maintenance of a sampling or inoculation device have a significant influence on the

21、overall safety. This is particularly because the consequences of release due to poor operation or maintenance are often greater than the consequences of incidental release due to the design of the sampling and inoculation devices. I Scope This European Standard gives guidance to the manufacturer of

22、sampling and inoculation devices on providing instructions in the manufacturer?s documentation accompanying his products in accordance with prEN 13312-3. It has the purpose of pointing out to him which hazards can occur during operation, so that he can take these into account in an adequate way duri

23、ng construction and will be in a position to formulate information for use giving adequate consideration of safety. This European Standard can also provide a framework for the user of sampling and inoculation devices to assess new or existing sampling or inoculation devices to implement a safe opera

24、tion and maintenance regime by restricting release, as necessary, of microorganisms into the workplace and the environment. Sampling and inoculation include the transfer of microorganisms from one closed system into another closed system like collection of samples or inoculation of a fermenter with

25、a starter cu Iture. This European Standard applies where the sampling or inoculation procedures include hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safe

26、ty. This European Standard is not applicable to transport to and from a safe place and final analysis of a sample, nor is it applicable to sampling of raw materials and air sampling devices used to determine microbial air quality in the workplace. QBSI 03-2000 STD-ES1 ES EN 13092-ENGL 2000 Lb24bb9 0

27、835365 283 H Page 5 EN 1 3092: 1999 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 in the text and the publications are listed hereafter. For dated references

28、, 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 to applies. prEN 13312-3 Biotechnology - Performance criteria for piping a

29、nd instrumentation - Part 3: Sampling and inoculation devices 3 Terms and definitions For the purposes of this standard, the following definitions apply. 3.1 accidental release unexpected release of process material to the environment during normal operation of equipment and the process 3.2 closed s

30、ystem system where a barrier separates microorganisms or organisms from the environment EN 16201 3.3 incidental release expected release of process material during normal operation of the equipment and process 3.4 inoculation addition of inoculum to a process 3.5 inoculation device device for adding

31、 microorganisms to a process OBSI 03-2000 STD-BSI BS EN 13092-ENCL 2000 = Lb24bb 08353bb LLT Page 6 EN 13092: 1999 3.6 inoculum microorganisms added to a process as seed material 3.7 leakage egress from equipment 3.8 leaktightness ability of component of equipment or unit of equipment to limit egres

32、s 3.9 manufacturer organization that designs, constructs, supplies and usually tests the equipment and materials NOTE By agreement with the purchaser the tests can be carried out by a third party. 3.10 microorganism any microbiological entity, cellular or non-cellular, capable of replication or of t

33、ransferring 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 genetically modified, cell cultures and human endoparasites which may be a

34、ble to provoke any infection, allergy or toxicity. 3.1 1 non-representative material material not representing the properties of process material 3.1 2 process microorganism microorganism used for production purposes in a biotechnological process or constituting (part of) the product itself OBSI 03-

35、2000 STD-BSI BS EN L3092-ENGL 2000 Lb24bb9 08353b7 05b = Page 7 EN 13092: 1 999 3.1 3 risk a combination of the probability and the degree of possible injury or damage to health in a hazardous situation EN 1 O701 3.14 sample material collected for analysis 3.15 sampling device device for taking samp

36、les from a component of equipment and/or a unit of equipment 3.16 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

37、accepted or recognized method of sterilization. NOTE 2 The process 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 ve

38、ry low numbers, but not to zero. However, these empirical functions can be applied to control or assess the process parameters of a sterilization procedure to realize a desired degree of inactivation of viable microorganisms. 3.17 user organization responsible for the biotechnological process who us

39、es equipment and materials as input 3.18 workplace the workplace is the defined area or areas in which the work activities are carried out EN 6891 OBSI 03-2000 STD-BSI BS EN 13092-ENGL 2000 Lb24bb9 08353b8 T92 Page 8 EN 13092: 1999 4 Hazards 4.1 General To limit the contact of microorganisms with pe

40、rsons and/or the environment the release of microorganisms during sampling or inoculation should be restricted. To control the contact of microorganisms with the workplace and the environment, the potential routes of release from the sampling or inoculation device should be identified and assessed.

41、These routes of release should be assessed against operating criteria which take into account the hazardous nature of the microorganism. The following situations should be assessed: - release of microorganisms during routine sampling and inoculation (including release by leakage); - release of micro

42、organisms after the sampling or inoculation procedure due to insufficient inactivation and/or removal of microorganisms when the sampling or inoculation device is opened or dismantled. 4.2 Types of hazards The types of hazard presented are dependent upon the type of device and its usage during sampl

43、ing and inoculation. The following hazards should be taken into account: - wrong sequencing of valves leading to a number of consequences such as discharge to drain, steam to the workplace, and process fluid to workplace environment; - sampling from a closed system into an open system could result i

44、n generation of aerosols and hence could cause release of microorganisms to the environment; - withdrawal of sampling or inoculation container resulting in leakage such as aerosols and/or seepage; - maintenance or dismantling being carried out without appropriate inactivation procedures; - sampling

45、often requires withdrawal of a quantity of non-representative material (e.g. first running). Safe collection and disposal of this part of the sample is needed; - sampling and inoculation containers could be dropped onto the floor by accident causing breakage and spill; - brittle (e.g. glass) bottles

46、 could be more vulnerable to shatter, e.g. by contact with steam or collision if the surface has become damaged by score marks or become chipped; - sampling and inoculation devices could be subjected to pressures greater than originally envisaged thus leading to leakage or to a bursting of the conta

47、iner. Examples are a location of the sampling and inoculation devices at the base of a tall tank where the hydrostatic pressure could be significant or an overpressure of gases in the headspace; OBSI 03-2000 STDmBSI BS EN L3092-ENGL 2000 Lb24669 0835369 929 Page 9 EN 13092: 1999 - sampling and inocu

48、lation devices using needle and septum could result in leakage with repeated insertion; - injury with a needle containing microorganisms could be significant; - poor installation or mounting of the sampling or inoculation devices could interfere negatively with the leaktightness, sterilizability or

49、cleanability. Possible additional hazards should be investigated by the user dependent upon the particular installation and use of the sampling and inoculation device. NOTE EN 12460 gives a guidance on equipment selection and installation in accordance with the biological risk (see l). 5 Methodology for preparation of a safe operation21 procedure 5.1 General The manufacturer should provide an instruction handbook for safe and faultless operation, containing information for using the sampling and inoculation device. In the instruction handbook he can give