EN 13312-3:2001

Biotechnology - Performance criteria for piping and instrumentation - Part 3: Sampling and inoculation devices

This European Standard specifies performance criteria for sampling and inoculation devices 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 sampling and inoculation device 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 3: Probenahme- und Beimpfungsvorrichtungen

Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Probenahme- und Beimpfungsvorrichtungen 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 Probenahme- und Beimpfungsvorrichtung den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren einschließt.

Biotechnologie - Critères de performance pour tuyauteries et instrumentation - Partie 3: Dispositifs d'échantillonnage et d'inoculation

La présente norme européenne spécifie les critères de performance des dispositifs d'échantillonnage et d'inoculation 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 dispositifs d'échantillonnage et d'inoculation impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux dans des procédés biotechnologiques.

Biotehnologija - Merila za delovanje cevne napeljave in pripomočke - 3. del: Naprave za vzorčenje in inokulacijo

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 13312-3:2002 - Biotechnology - Performance criteria for piping and instrumentation - Part 3: Sampling and inoculation devices

Overview

EN 13312-3:2001 - “Biotechnology - Performance criteria for piping and instrumentation - Part 3: Sampling and inoculation devices” is a European Standard published by CEN that defines performance criteria for sampling and inoculation devices used in biotechnological processes. The standard focuses on reducing potential risks to workers and the environment from microorganisms handled during bioprocessing. It applies when devices are intended for use with hazardous or potentially hazardous microorganisms or where exposure must be restricted for safety reasons.

Key topics and requirements

This part of EN 13312 sets out performance-focused expectations rather than prescriptive designs. Important technical topics covered include:

• Containment and exposure control - device performance to limit release of microorganisms to the operator and surroundings.
• Compatibility with bioprocess piping and instrumentation - integration of sampling and inoculation ports with process lines while maintaining integrity.
• Decontamination and cleanability - design features that facilitate effective cleaning, sterilization and safe decontamination after use.
• Operator safety and ergonomics - minimizing manual exposure during routine sampling and inoculation tasks.
• Environmental protection - measures to prevent contamination of the environment from process organisms.
• Performance validation and testing - criteria for demonstrating that devices meet safety and containment requirements (functional performance focus rather than prescriptive test methods).
• Documentation and marking - providing users with information on intended use, limitations, and safety precautions.

(EN 13312-3 emphasizes performance criteria; specific test methods or numeric thresholds are addressed by referenced procedures or complementary standards.)

Applications and who uses this standard

EN 13312-3 is intended for organizations and professionals involved in design, selection, installation and operation of sampling and inoculation equipment in biotechnology and related industries. Typical users include:

• Bioprocess and chemical engineers specifying sampling ports and inoculation devices
• Facility and piping designers integrating instrumentation into process lines
• Quality assurance and validation teams demonstrating containment performance
• Occupational health & safety officers and biosafety managers assessing worker exposure risks
• Manufacturers of sampling and inoculation devices seeking market compliance in Europe

Practical applications include sterile sampling of fermentation broths, inoculation interfaces for seed trains, and any point-of-use connections where microorganisms are handled under containment.

Related standards

Part 3 is one element of the EN 13312 series addressing piping and instrumentation for biotechnology. Complementary documents cover broader piping components, biosafety practices, and sterilizable connectors - consult national and international biosafety and process instrumentation standards for implementation details.

Relevant keywords: EN 13312-3:2001, sampling and inoculation devices, biotechnology standard, performance criteria, piping and instrumentation, bioprocess safety, containment, hazardous microorganisms.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 3: Probenahme- und BeimpfungsvorrichtungenBiotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 3: Dispositifs d'échantillonnage et d'inoculationBiotechnology - Performance criteria for piping and instrumentation - Part 3: Sampling and inoculation devices23.040.01Deli cevovodov in cevovodi na splošnoPipeline components and pipelines in general07.080Biologija. Botanika. Z
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