CHAPTER 13 STERILIZATION Introduction Sterilization is an important process in manufacture of sterile products. The process is used to destroy or remove the viable microorganisms which may be present in a product oF package, Thus, sterilization may be defined as @ process to destroy or remove all viable microorganisms from a product, Achieving absolute sterility is a probability. All the sterile products are not injected into the body. For example, ophthalmic preparations, preparations inserted through body cavity, etc. But, all these bypass the first-line defense system of the body - skin or mucous membrane of gastrointestinal tract. Thus, the sterlle products should be of highest quality for maximum safety of the end users. For this reason various attempts have been made by various agencies of national and international level to develop and standardize the methods, and to set up guide lines for the process of manufacture including sterilization processes. For example, International Couneil on Harmonization (ICH) have formulated guidelines, National Pharmacopoeia Committee have developed standards mentioned in their respective pharmacopoeias. Sterilization may involve several steps and techniques, The alm of the activity is to ‘ensure or achieve the maximum Sterility Assurance Level(SAL) at least 1 in a million, ie., Lin 10°(10°). Although with present technology even greater level of assurance can be achieved, still itis a probability and depends an various factors, The level of assurance for sterility of a product can indicate how the product has been manufactured, Primarily there are five components of manufacturing: ‘© Materials - active ingredients, additives, solvent and packaging materials. Methods of manufacturing, Equipments used, Manufacturing environment, and Personnel involved in all steps. ‘Thus, these are the basic sources of contamination. Quality should be built into the product and this is possible only when all these components are of highest quality and 480 Ul O <