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BS EN 12075:1997

Current
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

08-15-1997

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

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.

Committee
BTI/1
DevelopmentNote
Supersedes 95/124066 DC. (08/2005)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN 12075:1997 Identical
NS EN 12075 : 1ED 1997 Identical
NEN EN 12075 : 1997 Identical
I.S. EN 12075:1997 Identical
NBN EN 12075 : 1997 Identical
SN EN 12075 : 1997 Identical
NF EN 12075 : 1997 Identical
UNI EN 12075 : 1997 Identical
UNE-EN 12075:1997 Identical
DIN EN 12075:1997-03 Identical

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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