Biotechnology - Performance criteria for vessels - Part 5: Kill tanks

This European Standard specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of kill tanks includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Biotechnik - Leistungskriterien für Behälter - Teil 5: Abtötungsbehälter

1 Anwendungsbereich
Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Abtötungs-
behälter im Hinblick auf potentielle Gefährdungen für die Beschäftigten und die Umwelt fest, die von den
im Verfahren verwendeten Mikroorganismen ausgehen.
Diese Europäische Norm gilt, sobald die vorgesehene Anwendung von Abtötungsbehälter den Gebrauch
gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren einschließt, oder
wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganismen aus
Sicherheitsgründen eingeschränkt wird.

Biotechnologie - Criteres de performance des récipients - Partie 5: Cuves de décontamination

Domaine d'application
La présente Norme européenne spécifie les criteres de performance des cuves de décontamination utilisées dans les procédés biotechnologiques vis-a-vis des dangers potentiels que les microorganismes utilisés représentent pour l'opérateur et pour l'environnement.
La présente Norme européenne s'applique lorsqu'il est prévu que les cuves de décontamination impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux dans les procédés biotechnologiques ou lorsque l'exposition de l'opérateur ou de l'environnement a de tels microorganismes est limitée pour des raisons de sécurité.

Biotehnologija - Merila za delovanje posod - 5. del: Naprave za inaktivacijo mikroorganizmov v tekočinah ali odpadnih vodah

General Information

Status
Published
Publication Date
31-Dec-2001
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jan-2002
Due Date
01-Jan-2002
Completion Date
01-Jan-2002

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.QDNWLYDFLMRBiotechnik - Leistungskriterien für Behälter - Teil 5: AbtötungsbehälterBiotechnologie - Criteres de performance des récipients - Partie 5: Cuves de décontaminationBiotechnology - Performance criteria for vessels - Part 5: Kill tanks07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-5:2001SIST EN 13311-5:2002en01-januar-2002SIST EN 13311-5:2002SLOVENSKI

STANDARD
SIST EN 13311-5:2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-5March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 5: KilltanksBiotechnologie - Critères de performance des récipients -Partie 5: Cuves de décontaminationBiotechnik - Leistungskriterien für Behälter - Teil 5:AbtötungsbehälterThis 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 13311-5:2001 ESIST EN 13311-5:2002

Page 2EN 13311-5:2001Contents PageForeword.................................................................................................................3Introduction.....................................................................................................................41Scope...........................................................................................................................42Normative references....................................................................................................43Terms and definitions...................................................................................................44Hazards..........................................................................................................................45Performance classes.....................................................................................................56Types of kill tanks..........................................................................................................57Classification and verification of performance.............................................................68Marking and packaging.................................................................................................79Documentation...............................................................................................................7Annex A (informative)

Guidance on test methods for determining leaktightnessof kill tanks..........................................................................................................................8Annex B (informative)

Examples of kill tank systems.....................................................9Annex C (informative)

Guidance on materials, design and manufacture.....................10Bibliography......................................................................................................................11SIST EN 13311-5:2002

Page 3EN 13311-5:2001ForewordThis 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 13311-6, Biotechnology - Performance criteria for vessels - Part 6: Chromatographycolumns.Annexes A, B and C are informative.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 13311-5:2002

Page 4EN 13311-5:2001IntroductionKill tanks are used to inactivate microorganisms in liquids or slurries by subjecting them tosteam, heat, chemicals

or radiation. Kill tanks are part of the closed system but can be usedas well for treatment of waste water from for example sewers and showers. Kill tanks can becontinuous or batch operated systems. Examples of kill tank systems are given in annex B.Kill tanks are used to inactivate process microorganisms prior to release from the closedsystem or to further downstream processing in uncontained conditions.Use of this European Standard will aid the equipment manufacturer in the classification of killtanks with regard to safe performance in biotechnological processes. The classification iseasily understandable and readily utilizable for the user and the regulatory authorities.1ScopeThis European Standard specifies performance criteria for kill tanks 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 kill tanks includes hazardous orpotentially hazardous microorganisms used in biotechnological processes or where exposureof the worker or the environment to such microorganisms is restricted for reasons of safety.2Normative referencesThis European Standard incorporates by dated or undated references, 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 13311-1:2001Biotechnology - Performance criteria for vessels - Part 1 : Generalperformance criteria3Terms and definitionsFor the purposes of this standard, the terms and definitions given in EN 13311-1:2001 apply.4HazardsThe following hazards shall be taken into account.a) Release of microorganisms by leakage before or during operation.b) Release of microorganisms by exhaust gases.c) Release of microorganisms caused by insufficient inactivation when the load of the killtank is discharged or further processed or when the kill tank is opened or dismantled.SIST EN 13311-5:2002

Page 5EN 13311-5:20015Performance classesThe kill tanks shall be classified for leaktightness, cleanability and sterilizability inaccordance with 5.1 to 5.4 of EN 13311-1:2001.The selection of the appropriate class for performance of a kill tank shall be made inaccordance with 5.5 of EN 13311-1:2001.6Types of kill tanks6.1Type I kill tankA kill tank meeting the following requirements shall be classified as type I :a)the kill tank shall be capable of bringing its load to time and temperature conditions orother conditions known to destroy or inactivate all target microorganisms in the load ;andb)the kill tank shall have as a minimum the performance rating given in table 1.6.2Type II kill tankA kill tank meeting the following requirements shall be classified as type II :a)the kill tank shall be capable of bringing its load to time and temperature conditions orother conditions known to destroy or inactivate all target microorganisms in the load ;b)the kill tank shall have as a minimum the performance rating given in table 1 ; andc)the kill tank shall have additional containment features which prevent release of livingmicroorganisms to the environment before or during the operating cycle.NOTE 1

Release of microorganisms can occur by the exhaust air escaping from thekill tank while operating temperature and pressure are being reached, or when conden-sate for example from exhaust filters is released during or after the operating cycle.NOTE 2

Appropriate measures to prevent loss of containm
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