SIST EN 13312-5:2002
(Main)Biotechnology - Performance criteria for piping and instrumentation - Part 5: Valves
General Information
- Abstract
This European Standard specifies performance criteria for valves 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 valve 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.
- Status
- Published
- Publication Date
- 31-Dec-2001
- 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
Overview
EN 13312-5:2001 (CEN) is a European Standard that defines performance criteria for valves used in biotechnological processes where the presence of hazardous or potentially hazardous microorganisms creates risks to workers or the environment. The standard applies when valve use involves containment or when exposure to microorganisms is restricted for safety reasons. It focuses on ensuring valves meet safety, containment and hygienic requirements within biotechnology piping and instrumentation systems.
Key topics and requirements
While EN 13312-5:2001 is a performance-oriented document rather than a prescriptive design code, it addresses a set of technical topics and requirements relevant to biotech valves, including:
- Containment and leakage control - performance criteria to minimise release of microorganisms to workers or the environment.
- Cleanability and sterilizability - requirements to ensure valves can be effectively cleaned, sterilised or decontaminated in-process or during maintenance.
- Materials and surface finish - considerations for material compatibility with bioprocess media and resistance to cleaning/sterilisation agents.
- Sealing and closure performance - expectations for reliable seals under process conditions to prevent cross-contamination and leaks.
- Operation and actuation - functional criteria for manual, pneumatic or automated actuation compatible with containment strategies and process control.
- Maintenance, inspection and testing - performance-based requirements for validation, routine testing and maintenance intervals to sustain safe operation.
- Documentation and traceability - expectations for marking, technical documentation and records to support qualification and regulatory compliance.
(Note: EN 13312-5 defines performance criteria in the context of biotechnological safety; it does not prescribe specific designs or numeric test thresholds in this summary.)
Applications
EN 13312-5:2001 is directly applicable to:
- Manufacturers of valves and valve assemblies intended for biotech and pharmaceutical processes.
- Process, piping and instrumentation engineers designing bioprocess plants where containment of microorganisms is required.
- Validation, quality assurance and safety teams responsible for equipment qualification, cleaning validation and risk assessment.
- Procurement and maintenance departments selecting valves for aseptic or containment applications.
Use cases include containment of hazardous cultures, sterile transfer lines, bioreactor feed and waste lines, and any piping where worker/environmental exposure to microbes must be controlled.
Related standards
- Part of the EN 13312 series on biotechnology piping and instrumentation (other parts address piping, fittings and instrumentation).
- Complementary to industry GMP, biosafety and equipment validation guidance (refer to applicable national/regional regulations for implementation).
Keywords: EN 13312-5:2001, biotechnology valves, valve performance criteria, biotech piping and instrumentation, containment valves, cleanability, sterilizability, bioprocess safety.
Relations
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
SIST EN 13312-5:2002 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Performance criteria for piping and instrumentation - Part 5: Valves". This standard covers: This European Standard specifies performance criteria for valves 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 valve 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.
This European Standard specifies performance criteria for valves 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 valve 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.
SIST EN 13312-5:2002 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 23.060.01 - Valves in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 13312-5:2002 has the following relationships with other standards: It is inter standard links to SIST EN 13312-1:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 13312-5:2002 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 13312-5:2002 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 5: VentileBiotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 5: RobinetterieBiotechnology - Performance criteria for piping and instrumentation - Part 5: Valves23.060.01Ventili na splošnoValves in general07.080Biologi
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