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  • EN 12460:1998

    Current The latest, up-to-date edition.

    Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk

    Available format(s): 

    Language(s): 

    Published date:  17-02-1998

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Definitions
    3 Procedure for selection of equipment
    4 Verification of performance in practice
    5 Control
    6 Documentation
    Annex A (informative) Examples for a risk analysis
    Annex B (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 233
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN 13311-5:2001 Biotechnology. Performance criteria for vessels Kill tanks
    BS EN 13091:2000 Biotechnology. Performance criteria for filter elements and filtration assemblies
    EN 13311-4:2001 Biotechnology - Performance criteria for vessels - Part 4: Bioreactors
    EN 13311-1:2001 Biotechnology - Performance criteria for vessels - Part 1: General performance criteria
    EN 12884:1999 Biotechnology - Performance criteria for centrifuges
    EN 13311-5:2001 Biotechnology - Performance criteria for vessels - Part 5: Kill tanks
    EN 13312-1:2001 Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria
    EN 12690:1999 Biotechnology - Performance criteria for shaft seals
    BS EN 12884:1999 Biotechnology. Performance criteria for centrifuges
    BS EN 12885:1999 Biotechnology. Performance criteria for cell disrupters
    BS EN 13311-1:2001 Biotechnology. Performance criteria for vessels General performance criteria
    BS EN 13311-4:2001 Biotechnology. Performance criteria for vessels Bioreactors
    BS EN 13095:2000 Biotechnology. Performance criteria for off-gas systems
    BS EN 12690:1999 Biotechnology. Performance criteria for shaft seals
    EN 13092:1999 Biotechnology - Equipment - Guidance on sampling and inoculation procedures
    EN 13095:1999 Biotechnology - Performance criteria for off-gas systems

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 12297:1998 Biotechnology - Equipment - Guidance on testing procedures for sterilizability
    EN 12298:1998 Biotechnology - Equipment - Guidance on testing procedures for leaktightness
    EN 1050 : 1996 SAFETY OF MACHINERY - PRINCIPLES FOR RISK ASSESSMENT
    EN 1620:1996 Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
    EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
    EN 12296:1998 Biotechnology - Equipment - Guidance on testing procedures for cleanability
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