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  • BS EN 12075:1997

    Current The latest, up-to-date edition.

    Biotechnology. Large scale process and production. Procedures for fermentation and downstream processes

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-08-1997

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Process description
    5 Risk management
    Annex A (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Acts as a support to industrial activities in the biotechnology area, describing operations having both non-genetically modified and genetically modified micro-organisms with both non-pathogenic and pathogenic micro-organisms.

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

    Committee BTI/1
    Development Note Supersedes 95/124066 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN 1050 : 1996 SAFETY OF MACHINERY - PRINCIPLES FOR RISK ASSESSMENT
    EN ISO 9003:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
    EN 1620:1996 Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
    EN ISO 9000-1 : 1994 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 1: GUIDELINES FOR SELECTION AND USE (ISO 9000-1:1994)
    EN 1619:1996 Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    EN ISO 9004-1 : 1994 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
    EN 1826:1996 Biotechnology - Large-scale process and production - Control procedures for raw materials
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