WHO Methods of Analysis_ 5 pharma technical procedures_5.8 methods of sterilization.docVIP

Methods of Analysis: 5. Pharmaceutical technical procedures: 5.8 Methods of sterilization Sterilization is necessary for the complete destruction or removal of all microorganisms (including spore-forming and non-spore-forming bacteria, viruses, fungi, and protozoa) that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard. Since the achievement of the absolute state of sterility cannot be demonstrated, the sterility of a pharmaceutical preparation can be defined only in terms of probability. The efficacy of any sterilization process will depend on the nat