ABSTRACT
Sterilization processes are used to destroy or eliminate the microorganisms that are present on the surfaces or materials to aid in providing a safe pharmaceutical product for the patient. This chapter discusses the subset of aseptic processing, sterilizing filtration. Sanitizing destroys the microorganisms however it may or may not achieve the same lethality offered by sterilization cycles. Some companies use the term sanitization when describing processes used to reduce bioburden, without needing all of the validation and documentation associated with a sterilization cycle. Chemical sterilization methods are also useful in re-sterilizing medical devices, sterilizing in place lines within equipment, decontaminating equipment and drains, and the like. Chemical sterilization methods can be useful for these types of situations. As such, many regulatory documents specify the use of these spores in the validation of moist heat sterilization cycles.
