Sterility assurance definition

Even though the definition of sterility is an absolute condition, the effectiveness of the sterilization process can be determined by measuring the reduction of microbial population. Such measurements reveal the kinetics of microbial inactivation, and it is from the exponential nature of inactivation that the concept of sterility assurance level (SAL) is derived. This value... 

There are many definitions of quality (see Sharp, 2000). For the purpose of pharmaceutical products the term quality is usually taken to mean fitness for purpose. Not only must the product have the desired therapeutic properties it must also be safe for administration by the route intended. Some products such as injections must be sterile, while others such as oral drugs need not be sterile, but must be free from pathogens that can be contracted via the oral route (British Pharmacopoeia, 2003, Appendix XVID). A great deal more space in the literature is dedicated to quality of sterile products, but this reflects the additional quality assurance required compared with that for non-sterile products (Sharp, 2000). 

Each monograph contains the following information name of the substance or medicinal product, definition, packaging, storage, labeling requirements and specifications (tests, procedures for the tests and acceptance criteria). The USP also contains several general chapters. There are five general chapters about pharmaceutical preparation sterile preparations, non-sterile preparations, pharmaceutical calculations in extemporaneous preparation, quality assurance, and prescription balances and volumetric apparatus. 

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