Introduction

STERILIZATION PROCEDURES AND STERILITY ASSURANCE

INTRODUCTION

Sterilization is an essential stage in the processing of any product destined for parenteral administration, or for contact with broken skin, mucosal surfaces, or internal organs, where the threat of infection exists. In addition, the sterilization of microbiological materials, soiled dressings and other contaminated items is necessary to minimize the health hazard associated with these articles.

Sterilization processes involve the application of a biocidal agent or physical microbial removal process to a product or preparation with the object of killing or removing all microorganisms. These processes may involve elevated temperature,reactive gas, irradiation or filtration through a microorganism-proof filter. The success of the process depends on a suitable choice of treatment conditions, e.g. temperature and duration of exposure. It must be remembered, however, that with all articles to be sterilized there is a potential risk of product damage, which for a pharmaceutical preparation may result in reduced therapeutic efficacy, stability or patient acceptability. Thus, there is a need to achieve a balance between the maximum acceptable risk of failing to achieve sterility and the maximum level of product damage that is acceptable. This is best determined from a knowledge of the properties of the sterilizing agent, the properties of the product to be sterilized and the nature of the likely contaminants. A suitable sterilization process may then be selected to ensure maximum microbial kill/removal with minimum product deterioration.