What is BS EN 13091 - Performance criteria for filter elements and filtration assemblies about?
BS EN 13091 is a European standard that outlines the performance criteria for filter elements and filtration assemblies used in the biotechnological process concerning the potential risk of microorganisms in use for the worker and the environment.
BS EN 13091 applies to the intended use of the filter elements or filtration assemblies including hazardous or potentially hazardous microorganisms used in the biotechnological process and where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
BS EN 13091 also applies to serializability and cleanability of filter assemblies and leakage of microorganisms through the housing of a filtration assembly or leakage of microorganisms through the filter for dead-end filtration and crossflow filtration.
Note: BS EN 13091 does not apply to filter elements and filtration assemblies used to avoid contamination of bioreactors, for example by sterilizing intel air or feed stream.
Who is BS EN 13091 - Performance criteria for filter elements and filtration assemblies for?
BS EN 13091 on performance criteria for filter elements and filtration assemblies is useful for:
- Manufacturers of filter elements and filtration assemblies
- Biotechnology laboratories
- Regulatory authorities
Why should you use BS EN 13091 - Performance criteria for filter elements and filtration assemblies?
Filter elements by nature are not intended to prevent the passage of fluids, but to remove or reduce the microorganism load to acceptable levels, by retention of the target microorganisms within the filter medium. Leaktightness refers to the ability of the filtration assembly to retain the target microorganisms.
BS EN 13091 guideline assists you with hazards, performance classes, classification of performance, verification of performance, marking, and packaging for evaluating the performance of filter elements and filtration assemblies.
BS EN 13091 aid the equipment manufacturer in the classification of filter elements and filtration assemblies concerning biosafety performance in biotechnological processes. The classification of filter elements and filtration assemblies makes it easily understandable and readily utilizable for the user and the regulatory authorities.
With obedience and compliance to BS EN 13311-1, you can standardise the performance of filter elements and filtration assemblies used in the biotechnology process by meeting the general performance criteria and reducing the microorganism load to acceptable levels.
