EN 1619:1996
(Main)Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
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.
Biotechnik - Verfahren im Großmaßstab und Produktion - Allgemeine Anforderungen für Verwaltung und Organisation bei Verfahren zur Stammkonservierung
Diese Europäische Norm legt allgemeine Anforderungen an Verwaltung und Organisation für die Konservierung von Mikroorganismen fest, die für Verfahren im Großmaßstab und Produktion verwendet werden. Es ist beabsichtigt, eine sichere Handhabung zu ermöglichen sowie sicherzustellen, daß reproduzierbare Ergebnisse im biotechnischen Verfahren erhalten werden.
Biotechnologie - Procédé à grande échelle et production - Exigences générales de gestion et d'organisation pour les procédures de conservation des souches
La présente norme spécifie les exigences générales pour la gestion et l'organisation des procédures pour la conservation des microorganismes utilisés dans les procédés à grande échelle et la production. Celles-ci ont pour but de garantir une manipulation en toute sécurité mais aussi de l'obtention de résultats reproductibles dans les procédés biotechnologiques.
Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Splošne zahteve za vodenje in organizacijo v postopkih shranjevanja sevov
General Information
- Status
- Published
- Publication Date
- 23-Jul-1996
- Technical Committee
- CEN/TC 233 - Biotechnology
- Drafting Committee
- CEN/TC 233/WG 2 - Large-scale process and production
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
Overview
EN 1619:1996 is a European Standard developed by CEN that defines the general requirements for management and organization of strain conservation procedures in biotechnology. Specifically, it applies to the conservation of microorganisms utilized in large-scale industrial processes and production. The standard aims to ensure the safe handling of microbial strains and the reproducibility of biotechnology process results, making it an essential guideline for organizations involved in large-scale microbial management.
By implementing EN 1619:1996, companies can optimize their microbial strain preservation practices, reduce contamination risks, and maintain the integrity of their biotechnological products and processes. This standard supports quality assurance in biotechnology and aligns with good manufacturing practices.
Key Topics
- Management Requirements
Frameworks and organizational responsibilities for effective strain conservation - Strain Conservation Procedures
Principles and protocols for safely storing and maintaining microbial strains - Safety Measures
Guidelines to minimize contamination and ensure biohazard security during storage and handling - Process Reproducibility
Ensuring consistent results in large-scale biotechnology production by preserving strain quality - Documentation and Record Keeping
Maintaining accurate records for traceability and compliance purposes - Organizational Structure
Roles and qualifications necessary for personnel managing strain conservation activities
Applications
EN 1619:1996 is highly relevant for companies and institutions engaged in:
- Industrial Biotechnology
Large-scale fermentation, enzyme production, biofuel generation, and pharmaceutical manufacturing - Microbial Culture Collections
Repositories managing extensive libraries of microorganisms for research and industrial use - Quality Management Systems
Integration with ISO 9001 and other quality standards in biotech production environments - Research and Development
Laboratories working on strain improvement and bioprocess optimization requiring robust strain preservation - Agricultural and Environmental Biotechnology
Preserving microbial inoculants, biofertilizers, and biodegradation agents
Implementing EN 1619 helps organizations maintain microbial strain viability and genetic stability, which are critical for process efficiency, regulatory compliance, and product quality.
Related Standards
- EN ISO 9001 - Quality Management Systems
Establishes general principles for quality management applicable to biotechnology - EN ISO 13485 - Medical Devices
Includes relevant requirements for microbial handling in biotech medical products - ISO 14644 - Cleanrooms and Associated Controlled Environments
Provides environmental control guidance complementing strain conservation efforts - CEN/TC 334 Biotechnology Standards
Covers various aspects of biotechnology processes and quality requirements - National Guidelines on Biological Material Storage
Regional standards harmonizing with EN 1619 for safe microbial management
By aligning with EN 1619:1996, organizations can ensure their strain conservation procedures meet European safety and quality expectations, fostering trust and efficiency in biotechnology production.
Frequently Asked Questions
EN 1619:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures". This standard covers: 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.
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.
EN 1619:1996 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1619:1996 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Splošne zahteve za vodenje in organizacijo v postopkih shranjevanja sevovBiotechnik - Verfahren im Großmaßstab und Produktion - Allgemeine Anforderungen für Verwaltung und Organisation bei Verfahren zur StammkonservierungBiotechnologie - Procédé a grande échelle et production - Exigences générales de gestion et d'organisation pour les procédures de conservation des souchesBiotechnology
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