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1、BRITISH STANDARD BS EN 13311-3:2001 Biotechnology Performance criteria for vessels Part 3: Glass pressure vessels The European Standard EN 13311-3:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sh
2、effieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13311-3:2001 This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on
3、15 May 2001 BSI 05-2001 ISBN 0 580 37397 5 National foreword This British Standard is the official English language version of EN 13311-3:2001. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: A list of organizations
4、 represented on this committee can be obtained on request 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 entitled “International Standards Corre
5、spondence Index”, or by using the “Find” facility of the BSI 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 no
6、t of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promul
7、gate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 9 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateCommen
8、ts Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13311-3 March 2001 ICS 07.080; 07.100.01 English version Biotechnology - Performance criteria for vessels - Part 3: Glass pressure vessel
9、s Biotechnologie - Critres de performance des rcipients - Partie 3: Rcipients sous pression en verre Biotechnik - Leistungskriterien fr Behlter - Teil 3: Druckbehlter aus Glas This European Standard was approved by CEN on 4 February 2001. CEN members are bound to comply with the CEN/CENELEC Internal
10、 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 concerning such national standards may be obtained on application to the Management Centre or to any CEN member. Thi
11、s European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the
12、national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCH
13、ES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13311-3:2001 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontr
14、olled Copy, (c) BSI Page 2 EN 13311-3:2001 ContentsPage Foreword 3 Introduction 4 1Scope. 4 2Normative references. 4 3Terms and definitions 4 4Hazards . 5 5Performance classes 5 6Classification and verification of performance 6 7Marking and packaging 6 8Documentation . 6 Annex A (informative) Guidan
15、ce on test methods for determining leaktightness of glass pressure vessels . 7 Annex B (informative) Information on glass pressure vessels. 8 Bibliography. 9 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 13311-3:2001 Foreword Thi
16、s 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 publication of an identical text or by endorsement, at the latest by September 2001,
17、and conflicting national standards shall be withdrawn at the latest by September 2001. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. This standard is one of a series of European Standards concerned with perfo
18、rmance criteria for vessels. These standards are : EN 13311-1, Biotechnology - Performance criteria for vessels - Part 1: General performance criteria. EN 13311-2, Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices. EN 13311-3, Biotechnology - Performance criteria
19、 for vessels - Part 3: Glass pressure vessels. EN 13311-4, Biotechnology - Performance criteria for vessels - Part 4: Bioreactors. EN 13311-5, Biotechnology - Performance criteria for vessels - Part 5: Kill tanks. EN 13311-6, Biotechnology - Performance criteria for vessels - Part 6: Chromatography
20、columns. Annexes A and B are informative. This standard includes a bibliography. 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, Franc
21、e, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 13311-3:2001 Introduction Glass pressure ves
22、sels are used in a wide variety of biotechnological processes, and vary considerably in scale and function. Glass pressure vessels used in biotechnology can include for example fermenters and feed vessels, reaction vessels, centrifuge tubes and buckets, chromatography columns, sampling bottles, rota
23、ry evaporators, jacketed homogenizers/cell disrupters and vessels used in cryogenic procedures. The mechanical safety of pressure vessels which can include glass vessels is described in EN 1595 (see 2) or for example a national pressure vessel code (see 1). Use of this European Standard will aid the
24、 equipment manufacturer in the classification of glass pressure vessels with regard to safe performance in biotechnological processes. The classification is easily understandable and readily utilizable for the user and the regulatory authorities. 1Scope This European Standard specifies performance c
25、riteria for glass pressure vessels used in biotechnological processes with respect to the potential hazards to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of glass pressure vessels includes hazardous or potentially hazardous microo
26、rganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. This European Standard also applies to pressure vessels used in biotechnological processes that are made of other brittle materials such as acryl
27、ate polymers or porcelain. This European Standard does not apply to small glass parts which form an integral part of equipment such as sight glasses. This European Standard should be used in conjunction with other relevant standards when substantial parts of glass or from other brittle materials are
28、 present. 2Normative 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, subsequent amendments to
29、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 (including amendments). EN 13311-1:2001, Biotechnology - Performance criteria for vessels
30、- Part 1 : General performance criteria. 3Terms and definitions For the purposes of this standard, the terms and definitions given in EN 13311-1:2001 apply. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 13311-3:2001 4Hazards The
31、following hazards shall be taken into account. a) Release of microorganisms caused by : 1) accidental breakage ; 2) leakage from the vessel connections during operation ; 3) explosion or implosion leading to release of vessel content ; 4) vessels weakened due to hairline fractures caused by knocks a
32、nd further affected during temperature cycling that occurs for example during sterilization. When the vessel is then put under pressure during routine operation, weaknesses in the structure can lead to rupture with total release of contents ; 5) flying glass in the event of an explosion ; NOTE 1 Mic
33、robial hazard is likely to be secondary to the hazard posed by flying glass in the event of an explosion. 6) breakage caused by overtightening or loosening upon repetitive heating or usage when making connections to glass vessels. NOTE 2 Glass to glass connections represent a higher risk due to mech
34、anical and thermal strain. b) Infections caused by cuts to workers from contaminated glass following breakage or explosion. NOTE 3 Contaminated glass may allow direct entry of microorganisms into the body through cuts. Recommendations for proper design and handling are given in annex B. 5Performance
35、 classes The glass pressure vessels shall be classified for leaktightness, cleanability and sterilizability in accordance with 5.1 to 5.4 of EN 13311-1:2001. NOTE For glass pressure vessels leaktightness usually refers to the leaktightness of connections, such as rubber or silicone piping, or the le
36、aktightness of the sealing gaskets, for example, between the top plate of a fermenter, and the glass vessel. The selection of the appropriate class for performance of a glass pressure vessel shall be made in accordance with 5.5 of EN 13311-1:2001. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct
37、29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 13311-3:2001 6Classification and verification of performance 6.1General The glass pressure vessels shall conform to the general requirements given in 6.1 of EN 13311-1:2001. 6.2Leaktightness The glass pressure vessels shall conform to
38、the requirements given in 6.2 of EN 13311- 1:2001. Guidance on test methods for determining leaktightness of glass pressure vessels is given in annex A. A leaktightness test should be performed on the assembled components. Vessels showing any sign of damage should be carefully examined before use. 6
39、.3Cleanability The glass pressure vessels shall conform to the requirements given in 6.3 of EN 13311- 1:2001. NOTE Glass vessels can be polished to give several grades of finish. Fire polished glass is often used where a high quality of finish, giving good cleanability, is required. 6.4Sterilizabili
40、ty The glass pressure vessels shall conform to the requirements given in 6.4 of EN 13311- 1:2001. Any glass vessel showing visible signs of damage shall be carefully examined before use. Alternatively, if a damaged vessel is repaired, it shall be reclassified. NOTE Glass pressure vessels can be ster
41、ilized by autoclaving, or by sterilizing in place (SIP). Autoclaving is often carried out on smaller pieces of equipment, but care should be taken to avoid knocking or damaging the vessel when transporting to or from the vessel. 7Marking and packaging The glass pressure vessels shall conform to the
42、requirements given in clause 7 of EN 13311-1:2001. 8Documentation The glass pressure vessels shall conform to the requirements given in clause 8 of EN 13311-1:2001. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 13311-3:2001 Annex
43、 A (informative) Guidance on test methods for determining leaktightness of glass pressure vessels A list of test methods for leaktightness is given in table A.1 of EN 12298 (see 3). From that list suitable test methods to the testing of glass pressure vessels are given in table A.1. Table A.1 - Suit
44、able alternative leaktightness test methods for glass pressure vessels NumberTest method 1Pressure loss - gas/air 2Pressure loss - liquid 3Helium probe 4SF6, e.g. Freona probe 5Thermal conductivity 6Ultrasonics 8Tracer-liquid dyes 11Electronic particle counting 12Tracer aerosol (NaCl) 14Qualitative
45、bioaerosol monitoring 15Quantitative bioaerosol monitoring 16Surface swabbing 17Surface conductivity 19Bacteria tightness NOTE Restrictive use of SF6 should be considered due to environment protection aFreon is an example of a suitable product available commercially. This information is given for th
46、e convenience of the user of this Standard and does not constitute an endorsement of CEN of these products. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 8 EN 13311-3:2001 Annex B (informative) Information on glass pressure vessels B.
47、1Protective sheathing Glass pressure vessels are generally covered with protective sheathing, if the risk assessment indicates an explosion or implosion hazard. In the case of fermenter vessels, this may be a metal casing, or the vessel may be enclosed in a protective perspex cabinet. Similarly, pro
48、tective screening may be placed between the vessel and the operator. B.2Pressure relief devices Pressure relief devices should be fitted to glass pressure vessels, which can approach their nominal pressure during operation. These protection devices should be designed to operate at a predetermined th
49、reshold value. B.3Design pressure related to vessel diameter The design pressure of glass vessels decreases with increasing diameter. For larger vessels, the design pressure will be quite low. Air supply to glass fermenters should be regulated to that it does not exceed a predetermined threshold value. B.4Autoclaving versus sterilizing in place Autoclaving of glass vessels is often less stressful than sterilizing in place, as there is a lower pressure and temperature differential across the glass. However, the action of placing the vessel into the autoclave