EN 13311-1:2001

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Merila za delovanje posod - 1. del: Splošna merila za delovanjeBiotechnik - Leistungskriterien für Behälter - Teil 1: Allgemeine LeistungskriterienBiotechnologie - Criteres de performance des récipients - Partie 1: Criteres généraux de performanceBiotechnology - Performance criteria for vessels - Part 1: General performance criteria07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-1:2001SIST EN 13311-1:2002en01-januar-2002SIST EN 13311-1:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-1March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 1:General performance criteriaBiotechnologie - Critères de performance des récipients -Partie 1: Critères généraux de performanceBiotechnik - Leistungskriterien für Behälter - Teil 1:Allgemeine LeistungskriterienThis European Standard was approved by CEN on 4 February 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13311-1:2001 ESIST EN 13311-1:2002

Page 2EN 13311-1:2001ContentsPageForeword.3Introduction.41Scope.42Normative references.43Terms and definitions.54Hazards.85Performance classes.86Classification and verification of performance.117Marking and packaging.128Documentation.12Bibliography.13SIST EN 13311-1:2002

Page 3EN 13311-1:2001ForewordThis 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 bypublication of an identical text or by endorsement, at the latest by September 2001, andconflicting national standards shall be withdrawn at the latest by September 2001.This European Standard has been prepared under a mandate given to CEN by theEuropean Commission and the European Free Trade Association.This standard is one of a series of European Standards concerned with performance criteriafor vessels. These standards are :EN 13311-1, Biotechnology - Performance criteria for vessels - Part 1: General performancecriteria.EN 13311-2, Biotechnology - Performance criteria for vessels - Part 2: Pressure protectiondevices.EN 13311-3, Biotechnology - Performance criteria for vessels - Part 3: Glass pressurevessels.EN 13311-4, Biotechnology - Performance criteria for vessels - Part 4: Bioreactors.EN 13311-5, Biotechnology - Performance criteria for vessels – Part 5: Kill tanks.EN 13311-6Biotechnology - Performance criteria for vessels - Part 6: Chromatographycolumns.This standard includes a bibliography.According to the CEN/CENELEC Internal Regulations, the national standards organizationsof 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, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom.SIST EN 13311-1:2002

Page 4EN 13311-1:2001IntroductionUse of this European Standard will aid the equipment manufacturer in the classification ofpressure protection devices, glass pressure vessels, bioreactors, kill tanks andchromatography columns with regard to safe performance in biotechnological processes.The classification is easily understandable and readily utilizable for the user and theregulatory authorities.1ScopeThis European Standard specifies performance criteria for vessels used in biotechnologicalprocesses with respect to the potential hazards to the worker and the environment frommicroorganisms in use.This European Standard applies where the intended use of the equipment includeshazardous or potentially hazardous microorganisms used in biotechnological processes orwhere exposure of the worker or the environment to such microorganisms is restricted forreasons of safety.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text andthe publications are listed hereafter. For dated references, subsequent amendments to orrevisions of any of these publications apply to this European Standard only whenincorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 1672-2, Food processing machinery - Basic concepts - Part 2 : Hygiene requirements.EN 12296, Biotechnology - Equipment - Guidance on testing procedures for cleanability.EN 12297, Biotechnology - Equipment - Guidance on testing procedures for sterilizability.EN 12298, Biotechnology - Equipment - Guidance on testing procedures for leaktightness.EN ISO 4287, Geometrical Product Specifications (GPS) - Surface texture: Profile method -Terms, definitions and surface texture parameters (ISO 4287:1997).EN ISO 4288, Geometrical Product Specifications (GPS) - Surface texture: Profile method -Rules and procedures for the assessment of surface texture (ISO 4288:1996).SIST EN 13311-1:2002

Page 5EN 13311-1:20013Terms and definitionsFor the purposes of this standard, the following terms and definitions apply.3.1arithmetical mean deviation of the profile (Ra)arithmetical mean of the absolute values of the profile departures within the sampling lengthEN ISO 4287]3.2bioreactorvessel, together with auxiliary components of equipment, used for the controlled cultivationof microorganismsNOTE
For biosafety purposes, auxiliary components of equipment such as valves,pipes, sensors and stirrers are restricted to those which can come in contact with thetarget microorganism. Feed vessels and dosing pumps are part of the bioreactor ifthey are coupled to the bioreactor during the cultivation process.3.3bursting discdisc designed to withstand a specified pressure beyond which it will burst in order to releasepressure from the system3.4cleancondition of (a) product, surface, device, gases and/or liquids with residual soil below adefined threshold level3.5cleanabilityability to be made clean3.6closed systemsystem where a barrier separates microorganisms or organisms
from the environment [EN1620]3.7glass pressure vesselvessel constructed completely or primarily from glass, which may be subjected to pressuresof 50 kPa (0,5 bar) or more, above or below atmospheric pressure during normal operationNOTE
A glass pressure vessel in the intention of this standard is also constructedcompletely from glass if some parts like top cover and/or bottom and/or connectingdevices are made from different material. A stainless steel vessel containing a glasswindow is not a glass pressure vessel in the intention of this standard.SIST EN 13311-1:2002

Page 6EN 13311-1:20013.8hazardintrinsic property or ability of something (e.g. any agent, equipment, material or process) tocause harm [EN 1620]NOTE
Harm is an injury or damage to health of people and/or to the environment.3.9inactivationdestruction of microorganisms3.10kill tankvessel used to inactivate a target microorganismNOTE
Kill tanks can be continuous or batch operated systems.3.11leakageegress from equipment3.12leaktightnessability of component of equipment or unit of equipment to limit egress3.13microorganismany microbiological entity, cellular or non cellular, capable of replication or of transferringgenetic material [EN 1619]NOTE
For the purposes of this standard, the term microorganism covers the termbiological agent, according to the Directive 90/679/EEC : microorganisms, includingthose which have been genetically modified, cell cultures and human endoparasiteswhich may be able to provoke any infection, allergy or toxicity.3.14pressure protection devicedevice used to prevent vessels from being subjected to pressures beyond the nominalpressure3.15pressure relief valvevalve that opens at a set threshold pressureSIST EN 13311-1:2002

Page 7EN 13311-1:20013.16process microorganismmicroorganism used for production purposes in a biotechnological process or constituting(part of) the product itself3.17residual soilsoil left after cleaning3.18riskcombination of the probability and the degree of the possible injury or damage to health in ahazardous situation [EN 1070]3.19sampling devicedevice for taking samples from component of equipment and/or unit of equipment3.20soilany unwanted matter (including product residues, microorganisms, dust and debris)[ISO/DIS 14159]3.21sterilestate of being free from viable microorganismsNOTE 1
In practice no such absolute statement regarding the absence of viablemicroorganisms can be proven. However, sterile conditions can be regarded asestablished by using an accepted or recognized method of sterilizati
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