Biotechnology. Performance criteria for vessels - Bioreactors

Biotechnology. Performance criteria for vessels - Bioreactors

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What is BS EN 13311-4 - Performance criteria for bioreactors about?

BS EN 13311 is a European standard that discusses the performance criteria for vessels in biotechnology. BS EN 13311-4 is the fourth part of a multi-part series that outlines the performance criteria for bioreactors used in biotechnological processes concerning the potential hazards to the worker and the environment from microorganisms in use to ensure safe performance in biotechnological processes.

BS EN 13311-4 applies where the intended use of bioreactors 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.

Who is BS EN 13311-4 - Performance criteria for bioreactors for?

BS EN 13311-4 on performance criteria for bioreactors is useful for:

  • Manufacturers of bioreactors
  • Biotechnology laboratories
  • Regulatory authorities

Why should you use BS EN 13311-4 - Performance criteria for bioreactors?

Bio is defined as a vessel that carries out a biological reaction and is used to culture aerobic cells for conducting cellular or enzymatic immobilisation.

BS EN 13311-4 assists you with hazards, performance classes, classification, and verification of performance regarding leak-tightness, cleanability and sterilizability, marking, and packaging, to improve the efficiency and durability of bioreactors used in the biotechnological process.

With obedience and compliance to BS EN 13311-4, you can standardise the performance of bioreactors used in the biotechnological process.