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EN 12075:1997

Current
Current

The latest, up-to-date edition.

Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes
Published date

02-19-1997

Publisher

Comite Europeen de Normalisation

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

This European Standard describes the principles for the assessment and selection of fermentation and downstream operations so that they are carried out in a manner which ensures the safety of personnel and the environment and quality and safety of the product. It is intended for use by those designing and/or operating processes, by regulatory bodies and auditors, and by other interested parties. Unit operations are not described in detail and individual production processes can require specific equipment or unit operations which are not described here.

Committee
CEN/TC 233
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
NBN EN 1620 : 1996 Identical
NS EN 12075 : 1ED 1997 Identical
PN EN 12075 : 2002 Identical
SN EN 12075 : 1997 Identical
NF EN 12075 : 1997 Identical
BS EN 12075:1997 Identical
NEN EN 12075 : 1997 Identical
I.S. EN 12075:1997 Identical
NBN EN 12075 : 1997 Identical
UNI EN 12075 : 1997 Identical
UNE-EN 12075:1997 Identical
DIN EN 12075:1997-03 Identical

EN 1620:1996 Biotechnology - Large-scale process and production - Plant building according to the degree of hazard

ISO 9004-1:1994 Quality management and quality system elements Part 1: Guidelines
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
ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
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
ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
ISO 9000-1:1994 Quality management and quality assurance standards — Part 1: Guidelines for selection and use

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