EN 13312-4:2001

Biotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes

This European Standard specifies performance criteria for tubes and pipes 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 tubes and pipes 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 4: Rohre und Rohrleitungen

Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Rohre und Rohrleitungen 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 Rohre und Rohrleitung 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 - Critères de performance pour tuyauteries et instrumentation - Partie 4: Tubes et tuyauterie

La présente norme européenne spécifie les critères de performance des tubes et tuyauterie 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 tubes et tuyauterie impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux dans des procédés biotechnologiques ou lorsque l'exposition de l'opérateur ou de l'environnement à de tels microorganismes est limitée pour des raisons de sécurité.

Biotehnologija - Merila za delovanje cevne napeljave in pripomočke - 4. del: Cevi in izvodila

General Information

• Status: Published
• Publication Date: 20-Feb-2001
• Withdrawal Date: 30-Aug-2001
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: CEN/TC 233 - Biotechnology
• Drafting Committee: CEN/TC 233/WG 4 - Equipment
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 01-Oct-2025
• Completion Date: 08-Oct-2025
• 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: SIST EN 13312-4:2002 - Biotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes

Overview

EN 13312-4:2001 is a key European Standard developed by CEN that defines performance criteria for tubes and pipes used in biotechnological processes. The standard focuses on ensuring safety by addressing potential risks posed by hazardous or potentially hazardous microorganisms handled within piping systems. It applies specifically when tubing and piping components are used in environments where exposure to such microorganisms must be carefully controlled to protect both workers and the environment.

This standard is essential for industries engaged in biotechnology, where containment and hygiene of bioprocessing equipment, including pipes and instrumentation, are critical. It supports safe design, selection, and maintenance of tubing systems that prevent microbial contamination and exposure, helping organizations comply with regulatory safety requirements.

Key Topics

• Performance criteria for tubes and pipes in biotechnology applications
• Protection against microbiological hazards in bioprocess systems
• Safety considerations for worker exposure to dangerous microorganisms
• Environmental safety measures related to containment and leak prevention
• Specifications applicable to the use of tubing and piping in processes involving hazardous microbes
• Guidance for manufacturing and testing of piping components to meet biotechnological safety standards

Applications

EN 13312-4:2001 is widely applied in various biotechnological industries and facilities, including:

• Pharmaceutical manufacturing processes involving microbial cultures and fermentations
• Production plants dealing with genetically modified organisms (GMOs)
• Research laboratories where biological agents require safe containment
• Waste treatment systems processing biotechnological effluents
• Food and beverage biotechnology that employs microbial bioprocessing
• Any bioprocess environment requiring controlled exposure and stringent hygiene standards

Implementing this standard helps organizations minimize risks of biological contamination, maintain occupational health, and protect ecosystems from accidental release of microorganisms.

Related Standards

For a comprehensive safety and quality management system in biotechnology piping and instrumentation, EN 13312-4:2001 should be considered alongside related standards such as:

• EN 13312-1 series – General performance criteria for piping and instrumentation in biotechnology
• ISO 9001 – Quality management systems for manufacturing and process control
• ISO 14644 – Standards for cleanroom environments critical in bioprocessing
• EN 14126 – Protective clothing requirements for working with infective agents
• Good Manufacturing Practice (GMP) guidelines for pharmaceutical and food biotechnology pipelines

Together, these standards provide a robust framework to ensure effective control, safety, and performance of biotechnological piping systems.

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By following EN 13312-4:2001, organizations can ensure their tubing and piping components meet stringent safety requirements, enabling safer biotechnological operations with reduced risk to personnel and environment. This standard is a critical tool for biotechnology companies aiming to maintain high safety standards while supporting innovation and process efficiency.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.L]YRGLODBiotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 4: Rohre und RohrleitungenBiotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 4: Tubes et tuyauterieBiotechnology - Performance criteria for piping and instrumentation - Part 4: Tubes and pipes23.040.01Deli cevovodov in cevovodi na splošnoPi
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