WHO Method 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 nature of the product, the extent and type of any contamination, and the conditions under which the final product has been prepared. The requirements for Good Manufacturing Practice should be observed throughout all stages of manufacture and sterilization. Classical sterilization techniques using saturated steam under pressure or hot air are the most reliable and should be used whenever possible. Other sterilization methods include filtration, ionizing radiation (gamma and electron-beam radiation), and gas (ethylene oxide, formaldehyde). For products that cannot be sterilized in the final containers, aseptic processing is necessary. Materials and products that have been sterilized by one of the above processes are transferred to presterilized containers and sealed, both operations being carried out under controlled aseptic conditions. Whatever method of sterilization is chosen, the procedure must be validated for each type of product or material, both with respect to the assurance of sterility and to ensure that no adverse change has taken place within the product. Failure to follow precisely a defined, validated process could result in a non-sterile or deteriorated product. A typical validation programme for steam or dry-heat sterilization requires the correlation of temperature measurements, made with sensory devices to demonstrate heat penetration and heat distribution, with th