8. Microbiology

8.1 The need to include measures to prevent microbial growth and remove contamination where it has occurred should be considered.

8.2 There should be documented evidence to indicate that routine cleaning and storage of equipment does not allow microbial proliferation.

8.3 The period and conditions for storage of unclean equipment before cleaning, and the time between cleaning and equipment reuse, should form part of the validation of cleaning procedures.

8.4 Equipment should be stored in a dry condition after cleaning. Stagnant water should not be allowed to remain in equipment after cleaning.

8.5 Control of the bioburden through adequate cleaning and appropriate storage of equipment is important to ensure that subsequent sterilization or sanitization procedures achieve the necessary assurance of sterility, and the control of pyrogens in sterile processing. Equipment sterilization processes may not be adequate to achieve significant inactivation or removal of pyrogens.