EN 12296:1998
(Main)Biotechnology - Equipment - Guidance on testing procedures for cleanability
Biotechnology - Equipment - Guidance on testing procedures for cleanability
This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.
Biotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der Reinigbarkeit
Diese Europäische Norm gibt eine Anleitung für allgemeine Prüfverfahren zum Nachweis der Reinigbarkeit von in biotechnischen Verfahren verwendeten Geräten und Ausrüstungen (Bauteile und Apparateeinheiten). Diese Europäische Norm ist in erster Linie anzuwenden, wenn der bestimmungsgemäße Betrieb der Geräte und Ausrüstungen den Umgang solcher Mikroorganismen beinhaltet, die möglicherweise ein Gefährdungspotential besitzen.
Biotechnologie - Equipement - Guide des procédures d'essai pour le contrôle de la capacité au nettoyage
La présente norme européenne donne des lignes directrices sur les procédures d'essai générales permettant d'évaluer la capacité au nettoyage des équipements (composants individuels et unités d'équipement) mis en oeuvre dans les procédés biotechnologiques. La présente norme européenne s'applique en premier lieu aux équipements s'il est prévu que des microorganismes potentiellement dangereux y soient mis en jeu. Elle s'applique également à des microorganismes non dangereux et aux salissures résiduelles susceptibles d'affecter de façon néfaste les procédés de stérilisation.
Biotehnologija – Oprema - Navodilo o preskusnih postopkih za ugotavljanje čistosti
General Information
- Status
- Published
- Publication Date
- 17-Mar-1998
- Technical Committee
- CEN/TC 233 - Biotechnology
- Drafting Committee
- CEN/TC 233/WG 4 - Equipment
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
Overview
EN 12296:1998 - "Biotechnology - Equipment - Guidance on testing procedures for cleanability" is a CEN European Standard that provides guidance on general testing procedures to assess the cleanability of equipment (components and units) used in biotechnological processes. It applies primarily when equipment will be used with potentially hazardous microorganisms, and also covers non-hazardous microorganisms and residual soil that can interfere with sterilization or cause cross‑contamination. The standard supports hygienic design, cleaning validation, and risk reduction in bioprocessing environments.
Key topics and technical requirements
This guidance standard focuses on practical testing principles rather than prescriptive technical parameters. Key topics typically covered include:
- Scope of cleanability testing - definition of equipment items, components and units to be evaluated.
- Test planning - establishing objectives, test conditions and representative worst‑case scenarios for biologically contaminated soils.
- Soil and microorganism selection - use of relevant residues, surrogate soils or microorganisms that reflect process risks.
- Sampling and measurement - guidance on swabbing, rinsing, visual inspection and analytical methods to detect residual soil or viable organisms.
- Test procedures - recommended approaches to challenge surfaces and joints, flow paths and hard‑to‑clean areas; reproducible test set‑ups for comparative assessments.
- Evaluation and documentation - interpretation of test results, criteria for acceptability, and record‑keeping to support cleaning validation and compliance.
- Safety and containment - precautions when working with hazardous microorganisms during test work.
EN 12296 is a guidance document; it helps define appropriate test strategies rather than prescribing numerical acceptance limits, which are determined by users based on risk, process requirements and regulatory expectations.
Applications
EN 12296 is used to:
- Validate and document the cleanability of bioreactors, piping, fittings, valves, and containment equipment.
- Support cleaning validation programs and hygienic design reviews in biotech and pharmaceutical production.
- Compare alternative equipment designs or surface finishes for ease of cleaning.
- Reduce cross‑contamination risk and improve sterilization outcomes by identifying residual soil hotspots.
Who should use it
- Equipment manufacturers and designers seeking to prove hygienic design
- Bioprocess/production engineers and validation specialists
- Quality assurance, microbiology and contamination control teams
- Contract testing laboratories performing cleanability assessments
Related standards
EN 12296 complements other hygiene, cleaning‑validation and Good Manufacturing Practice (GMP) guidance and standards that address sterilization, microbiological monitoring and equipment qualification. Use EN 12296 when planning cleanability testing as part of an integrated contamination control strategy.
Keywords: EN 12296:1998, cleanability testing, biotechnology equipment, cleaning validation, bioprocess hygiene, CEN standard.
Frequently Asked Questions
EN 12296:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Equipment - Guidance on testing procedures for cleanability". This standard covers: This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.
This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.
EN 12296:1998 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.01 - Microbiology in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12296:1998 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.
EN 12296:1998 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.DYOMDQMHþLVWRVWLBiotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der ReinigbarkeitBiotechnologie - Equipement - Guide des procédures d'essai pour le contrôle de la capacité au nettoyageBiotechnology - Equipment - Guidance on testing procedures for cleanability07.080Biologija.
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