EN 1619:1996
Current
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The latest, up-to-date edition.
Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
Published date
24-07-1996
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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Development of master and working cell banks
5 Classification of micro-organisms
6 Preservation
7 Characterization
8 Handling and storage
9 Personnel and facilities
Annexes
A (informative) Classification of the micro-organisms
B (informative) Bibliography
This European Standard specifies general requirements for management and organization of procedures for conservation of microorganisms used for large-scale process and production. It is intended to secure safe handling and also to ensure that reproducible results are obtained in biotechnology processes.
| Committee |
CEN/TC 233
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 1619:1996 | Identical |
| NF EN 1619 : 1997 | Identical |
| I.S. EN 1619:1997 | Identical |
| NEN EN 1619 : 1996 | Identical |
| NS EN 1619 : 1ED 1996 | Identical |
| NBN EN 12307 : 1998 | Identical |
| UNI EN 1619 : 1999 | Identical |
| BS EN 1619:1997 | Identical |
| DIN EN 1619:1996-09 | Identical |
| PN EN 1619 : 2002 | Identical |
| NBN EN 1619 : 1996 | Identical |
| SN EN 1619 : 1997 | Identical |
| BS EN 12306:1998 | Biotechnology. Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination |
| BS EN 12689:1998 | Biotechnology. Guidance on assessment of the purity, biological activity and stability of micro-organism based products |
| BS EN 12075:1997 | Biotechnology. Large scale process and production. Procedures for fermentation and downstream processes |
| BS EN 13091:2000 | Biotechnology. Performance criteria for filter elements and filtration assemblies |
| BS EN 12347:1998 | Biotechnology. Performance criteria for steam sterilizers and autoclaves |
| BS EN 12307:1998 | Biotechnology. Large-scale process and production. Guidance for good practice, procedures, training and control for personnel |
| EN 12738:1999 | Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments |
| EN 12128:1998 | Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements |
| EN 13311-1:2001 | Biotechnology - Performance criteria for vessels - Part 1: General performance criteria |
| EN 12297:1998 | Biotechnology - Equipment - Guidance on testing procedures for sterilizability |
| EN 12306:1997 | Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination |
| EN 12307:1997 | Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel |
| EN 12462:1998 | Biotechnology - Performance criteria for pumps |
| EN 12689:1998 | Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products |
| EN 12740:1999 | Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste |
| EN 13312-1:2001 | Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria |
| EN 12461:1998 | Biotechnology - Large scale process and production - Guidance for the handling, inactivating and testing of waste |
| EN 12690:1999 | Biotechnology - Performance criteria for shaft seals |
| EN 12347:1998 | Biotechnology - Performance criteria for steam sterilizers and autoclaves |
| EN 12741:1999 | Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations |
| EN 12075:1997 | Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes |
| BS EN 12460:1998 | Biotechnology. Large-scale process and production. Guidance on equipment selection and installation in accordance with the biological risk |
| BS EN 12884:1999 | Biotechnology. Performance criteria for centrifuges |
| BS EN 12885:1999 | Biotechnology. Performance criteria for cell disrupters |
| BS EN 12738:1999 | Biotechnology. Laboratories for research, development and analysis. Guidance for containment of animals inoculated with microorganisms in experiments |
| BS EN 13311-1:2001 | Biotechnology. Performance criteria for vessels General performance criteria |
| BS EN 12462:1998 | Biotechnology. Performance criteria for pumps |
| BS EN 12740:1999 | Biotechnology. Laboratories for research, development and analysis. Guidance for handling, inactivating and testing of waste |
| BS EN 12461:1998 | Biotechnology. Large-scale process and production. Guidance for the handling, inactivating and testing of waste |
| BS EN 12297:1998 | Biotechnology. Equipment. Guidance on testing procedures for sterilizability |
| BS EN 13095:2000 | Biotechnology. Performance criteria for off-gas systems |
| BS EN 12128:1998 | Biotechnology. Laboratories for research, development and analysis. Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements |
| BS EN 12741:1999 | Biotechnology. Laboratories for research, development and analysis. Guidance for biotechnology laboratory operations |
| BS EN 12298:1998 | Biotechnology. Equipment. Guidance on testing procedures for leaktightness |
| EN 12298:1998 | Biotechnology - Equipment - Guidance on testing procedures for leaktightness |
| BS EN 12690:1999 | Biotechnology. Performance criteria for shaft seals |
| EN 12460:1998 | Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk |
| EN 13092:1999 | Biotechnology - Equipment - Guidance on sampling and inoculation procedures |
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