STERILIZATION PROCEDURES AND STERILITY ASSURANCE

Posted by admin on January 15, 2018 in Articles

CHAPTER 21
STERILIZATION PROCEDURES AND STERILITY ASSURANCE INTRODUCTIONSterilization
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 begins
sterilization of microbiological materials, soiled dressings and other contaminated items ? minimize health hazard associated with these articles
involve application of a biocidal agent or physical microbial removal process to a product or preparation with the object of killing or removing all microorganisms
may involve elevated temperature, reactive gas, irradiation or filtration through a microorganism-proof filter
success depends on suitable choice of treatment conditions (e.g. temperature and duration of exposure)
potential risk of product damage (for pharmaceutical preparation) ? reduced therapeutic efficacy, stability, or patient acceptability
need for a balance between the maximum acceptable risk of failing to achieve sterility and the maximum level of product damage that is acceptable (best determined from knowledge of properties of the sterilizing agent, properties of the product to be sterilized, and nature of likely contaminants
suitable sterilization process selected ? ensure maximum microbial kill/ removal with minimum product deterioration SENSITIVITY OF MICROORGANISMS general pattern of resistance of microorganisms to biocidal sterilization processes is independent of the type of agent employed (heat, radiation, or gas), with vegetative forms of bacteria and fungi, along with the larger viruses, showing a greater sensitivity to sterilization processes than small viruses and bacterial or fungal spores
choice of suitable reference organisms for testing the efficiency of sterilization processes are made from most durable bacterial spores: Bacillus stearothermophilus (moist heat), B. subtilis (dry heat and gaseous sterilization), B. pumilus…