EN 1619:1996

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
• ICS: 07.080 - Biology. Botany. Zoology
• 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: 11-Feb-2026
• Directive: Not Harmonized90/219/EEC - Contained use of genetically modified micro-organisms
• Directive:

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  Not Harmonized90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive:

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  Not Harmonized90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
• Mandate: M/BC/CEN/91/19 - Mandate for CEN on biotechnology
• Ref Project: SIST EN 1619:1999 - Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures

Relations

• Referred By: EN 12347:1998 - Biotechnology - Performance criteria for steam sterilizers and autoclaves
• Effective Date: 28-Jan-2026
• Referred By: EN 12306:1997 - Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
• Effective Date: 28-Jan-2026
• Referred By: EN 12307:1997 - Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
• Effective Date: 28-Jan-2026

Overview

EN 1619:1996 is a European Standard developed by CEN that addresses the management and organization of procedures for the conservation of microorganisms in biotechnology industries. This standard is essential for laboratories, production facilities, and research centers engaging in large-scale processes and production that rely on microbial strains. EN 1619:1996 outlines the general requirements necessary to ensure safe handling, effective strain conservation, and reproducibility of biotechnology processes involving microorganisms.

By providing a structured approach for strain maintenance and organization, this standard enables consistent results, enhances biological safety, and supports regulatory compliance in biotechnological applications.

Key Topics

EN 1619:1996 covers several core topics relevant to strain conservation in biotechnology, including:

• Management Systems: Establishing frameworks to organize and supervise strain collection processes and associated documentation.
• Organizational Requirements: Defining roles, responsibilities, and workflows for personnel involved in microbial strain conservation.
• Safe Handling Procedures: Ensuring that procedures for storing, retrieving, and managing strains prioritize safety to prevent contamination and exposure.
• Traceability and Documentation: Maintaining detailed records and traceability for all aspects of strain storage and usage to enable process reproducibility.
• Quality Assurance: Implementing quality management practices to sustain the long-term viability and integrity of conserved microorganisms.

Applications

The requirements set by EN 1619:1996 have practical applications across a variety of biotechnology environments:

• Industrial Biotechnology: Ensuring reliable production processes that utilize microorganisms for the manufacture of chemicals, enzymes, pharmaceuticals, and biofuels.
• Research Laboratories: Supporting reproducible research outcomes through standardized strain conservation procedures.
• Culture Collections: Managing large repositories of microbial strains used in academic, industrial, and public health sectors.
• Quality Control: Enhancing regulatory compliance by integrating standardized management practices for microbial strain handling.
• Process Development: Facilitating process optimization and scale-up by ensuring the consistency of biological starting material.

The standards help institutions minimize the risk of strain loss or contamination and enable scalability and transferability of biotechnological processes across different settings.

Related Standards

Organizations applying EN 1619:1996 should consider other relevant standards that complement its requirements, such as:

• ISO 9001: Quality management systems standards, applicable to process quality and documentation.
• EN 12322: Biotechnology - Requirements for the storage of microorganisms.
• OECD Best Practice Guidelines for Biological Resource Centres: Guidance on the safe and reliable management of microorganism collections.
• EN 12442: Standards for the traceability of biological materials in medical, pharmaceutical, and food sectors.

By integrating EN 1619:1996 with these and related standards, organizations can strengthen their management systems, achieve regulatory compliance, and promote safety and efficiency in biotechnology processes involving microorganism conservation.

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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