Name: EN 1619:1996
Brand: CEN

Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures

Published date

24-07-1996

Publisher

Comite Europeen de Normalisation

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