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.
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.
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