SIST EN 13312-2:2002

Biotechnology - Performance criteria for piping and instrumentation - Part 2: Couplings

This European Standard specifies performance criteria for couplings used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the coupling includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 2: Verbindungsstücke

Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Verbindungsstücke im Hinblick auf potentielle Risiken für die Beschäftigten und die Umwelt fest, die von den im Verfahren verwendeten Mikroorganismen ausgehen.  Diese Europäische Norm gilt, sobald die vorgesehene Anwendung der Verbindungsstücke den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren einschließt, oder wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganismen aus Sicherheitsgründen eingeschränkt wird.

Biotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 2: Raccords

La présente norme européenne spécifie les critères de performance des raccords utilisés dans les procédés biotechnologiques vis-à-vis des risques potentiels que les microorganismes utilisés représentent pour l'opérateur et pour l'environnement.  La présente norme européenne s'applique lorsqu'il est prévu que les raccords impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux ou lorsque l'exposition de l'opérateur ou de l'environnement à de tels microorganismes est limité pour des raisons de sécurité.

Biotehnologija - Merila za delovanje cevne napeljave in pripomočke - 2. del: Povezovalni elementi

General Information

• Status: Published
• Publication Date: 31-Dec-2001
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 23.040.01 - Pipeline components and pipelines in general
• Technical Committee: BTH - Biotechnology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jan-2002
• Due Date: 01-Jan-2002
• Completion Date: 01-Jan-2002
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 90/679/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: EN 13312-2:2001 - Biotechnology - Performance criteria for piping and instrumentation - Part 2: Couplings

Overview

EN 13312-2:2001 (CEN) is a European Standard that defines performance criteria for couplings used in biotechnological piping and instrumentation systems. The standard focuses on minimizing risks to workers and the environment arising from the use of hazardous or potentially hazardous microorganisms in bioprocessing. It applies where the coupling’s intended use involves containment or restricted exposure for safety reasons.

Key topics and requirements

While the full text provides the formal performance criteria, the standard centers on practical safety and containment attributes typically required for bioprocess couplings. Key technical topics include:

• Containment and leakage control – performance requirements to prevent release of microorganisms during normal operation, connection/disconnection and maintenance.
• Cleanability and sterilizability – design considerations and material selection that permit effective cleaning, sterilization (in situ and ex situ) and validation without compromising containment.
• Materials and compatibility – use of biocompatible, corrosion-resistant materials compatible with common sterilants and process media.
• Mechanical integrity and sealing – criteria for reliable mechanical performance under expected process conditions to maintain a sealed system.
• Operational safety – safe handling, assembly/disassembly features to reduce operator exposure and procedural risks.
• Documentation and marking – requirements for traceability, user instructions, and information needed for safe selection, installation and maintenance.
• Risk-based application – application of the criteria where exposure to hazardous microorganisms must be controlled, supporting risk assessments and biosafety measures.

Note: The standard is specifically scoped to performance criteria; it does not prescribe a single design or test method for all use cases-selection should be driven by process risk and facility biosafety level.

Practical applications

EN 13312-2:2001 is used to:

• Inform procurement specifications for couplings and quick-connects in bioprocess piping.
• Guide equipment and component manufacturers in designing couplings suitable for containment of microorganisms.
• Support validation and commissioning activities (cleanability, leak checks) in pharmaceutical and biotech facilities.
• Aid safety officers and process engineers in risk assessments and containment strategy planning.
• Standardize requirements for couplings in pilot plants, production bioreactors, and containment suites handling hazardous strains.

Who should use this standard

• Process and piping engineers in biotechnology and pharmaceutical manufacturing
• Equipment and coupling manufacturers and designers
• Quality assurance / validation teams
• Biosafety officers and facility managers
• Procurement specialists writing safety-focused technical specifications

Related standards

• Other parts of the EN 13312 series (piping and instrumentation performance criteria) and CEN standards on biosafety, piping components, and materials selection are typically consulted alongside EN 13312-2:2001 to create a complete compliance and safety framework.

Keywords: EN 13312-2:2001, biotechnology couplings, performance criteria, bioprocess piping, containment, sterility, worker safety, environmental protection.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 2: VerbindungsstückeBiotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 2: RaccordsBiotechnology - Performance criteria for piping and instrumentation - Part 2: Couplings23.040.01Deli cevovodov in cevovodi na splošnoPipeline component
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