scope:

Gives guidance on general procedures to assess the cleanability of equipment (components and assembled components) used in biotechnological processes. This standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This standard also applies to non-hazardous microorganisms and/or non-viable substances if they result in residual soil which might adversely affect with sterilization processes or which can cause cross-contamination of products or processes. This standard applies to plants or components such as, valves and fitting, tanks, pumps, piping, separating and filling devices as well as instrumentation in contact with process fluids.