EN 12075:1997
Current
The latest, up-to-date edition.
Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes
19-02-1997
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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