scope:

Gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes This standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can effect the safety of the worker (occupational health) and/or that can have adverse effects to the environment. This standard is applicable to complete plants, units or components, such as apparatus, valves and fittings, tanks, pumps, piping, separating and filling devices as well as instrumentation. This standard applies if the intended use of the equipment includes hazardous or potentially hazardous microorganisms. This standard is not applicable to testing for sterility of media and equipment prior to processing or operating, respectively.