SIST EN 13312-1:2002

Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria

This European Standard specifies performance criteria for piping and instrumentation 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 equipment 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 1: Allgemeine Leistungskriterien

Diese Europäische Norm legt Leistungskriterien für die in biotechnischen Verfahren verwendeten Leitungssysteme und Instrumente 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 Geräte und Ausrüstungen 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 1: Criteres généraux de performance

La présente norme européenne spécifie les critères de performance des tuyauteries et instrumentation 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 l'équipement implique l'utilisation de microorganismes dangereux ou potentiellement dangereux dans les 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 - 1. del: Splošna merila za delovanje

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
• Ref Project: EN 13312-1:2001 - Biotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria

Overview

EN 13312-1:2001 (CEN) sets out general performance criteria for piping and instrumentation used in biotechnological processes where microorganisms are handled. The standard focuses on safeguarding workers and the environment from potential exposure to hazardous or potentially hazardous microorganisms. It applies to equipment whose intended use involves containment or restricted exposure for safety reasons, and it establishes baseline expectations for design performance, operation and maintenance of piping systems and associated instrumentation in biotech facilities.

Key topics

This part of EN 13312 addresses broad, practical performance topics relevant to biosafety and process integrity, for example:

• Containment and leak prevention - criteria to minimize release of microorganisms from piping and joints.
• Material and component suitability - selection of materials compatible with biological agents, cleaning and sterilization.
• Joints, valves and connections - performance expectations for fittings to maintain integrity under process conditions.
• Instrumentation and monitoring - reliability and accuracy needs for sensors and control devices that affect containment and safety.
• Cleanability and decontamination - requirements that enable effective cleaning, sterilization and safe maintenance.
• Testing and verification - performance testing, inspection and validation approaches to demonstrate ongoing compliance.
• Maintenance and operational provisions - measures to reduce occupational and environmental risk during normal operation and interventions.

(As a Part 1 document, the standard provides general, cross-cutting performance criteria rather than process-specific technical parameters.)

Applications

EN 13312-1 is intended for organizations involved in the design, installation, operation and regulation of bioprocess piping and instrumentation, including:

• Process and piping engineers in pharmaceutical, biotech and industrial fermentation facilities
• Equipment manufacturers and suppliers of sanitary piping, valves and instrumentation
• Facilities and maintenance teams responsible for cleaning, sterilization and validation
• Health & safety, biosafety officers and quality assurance personnel ensuring worker and environmental protection
• Regulatory bodies and auditors assessing compliance with biosafety performance expectations

Using this standard helps reduce cross-contamination risk, improve occupational safety, and support consistent procurement and validation of piping and instrumentation in biotechnology operations.

Related standards

EN 13312-1 complements other European and international standards and guidelines addressing biosafety, sanitary design, sterilization practices and equipment validation. Organizations should apply EN 13312-1 alongside applicable biosafety regulations and process-specific standards to achieve comprehensive risk control and compliance.

Keywords: EN 13312-1, biotechnology piping, instrumentation performance criteria, bioprocess containment, biosafety piping standards, leak prevention, cleanability, CEN standard.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 1: Allgemeine LeistungskriterienBiotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 1: Criteres généraux de performanceBiotechnology - Performance criteria for piping and instrumentation - Part 1: General performance criteria23.040.01Deli cevovodov in cevovodi na splošnoPipeline components and pipelines in g
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