What is BS EN 13312-3 - Performance criteria for sampling and inoculation devices about?
BS EN 13312 is a European standard that discusses the performance criteria for piping and instrumentation in biotechnology. BS EN 13312-3 is the third part of a multi-part series that outlines the performance criteria for sampling and inoculation devices used in biotechnological processes concerning the potential hazards to the worker and the environment from microorganisms in use.
BS EN 13312-3 applies to the intended use of the sampling and inoculation device including 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.
Note: Where the device is included as an integral part of other units of equipment or components of equipment, the manufacturer of that equipment has the responsibility to interpret the appropriate safety standard (relative to that equipment) as inclusive of a complete device.
Who is BS EN 13312-3 - Performance criteria for sampling and inoculation devices for?
BS EN 13312-3 on performance criteria for sampling and inoculation devices is useful for:
- Manufacturers of sampling and inoculation devices Test centres
- Regulatory authorities
Why should you use BS EN 13312-3 - Performance criteria for sampling and inoculation devices?
The sampling and inoculation devices are used to remove material from or add material to the closed system. To perform a safe operation, the device should perform in such a way as not to breach the containment of the closed system.
BS EN 13312-3 aid equipment manufacturer in the classification of sampling and inoculation devices concerning safe 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.
BS EN 13312-3 guideline assists you with hazards, performance classes, classification of performance, verification of performance, marking, and packaging for evaluating the performance of sampling and inoculation devices used in the biotechnology process.
With obedience and compliance to BS EN 13312-1, you can standardise the performance of sampling and inoculation devices used in the biotechnology processes.
