USP <1229> addresses the subject of sterilization. As a general information chapter, it “provides an overview of the concepts and principles involved in sterilization (by various modes) of compendial articles that must be sterile.” Included in this main document is information on: validation of sterilization processes, establishing and justifying sterilization processes that rely on microbial inactivation, D-value and microbial resistance, biological and physical data, sterilization indicators and integrators, sterilization process development, and routine process control.
In USP, sterility is defined “in probabilistic terms that establish an acceptable level of risk. Sterility can be accomplished only by the use of a validated sterilization process under appropriate current good manufacturing practices and cannot be demonstrated by reliance on sterility testing alone.”
There are a few basic principles to consider in regards to your sterilization processes: When you are developing your the process, make sure you choose the appropriate sterilization mode; take into consideration the compatibility of materials with your chosen mode; identify the parameters of your sterilization process to allow any microorganisms to be killed while maintaining the integrity of the materials being exposed in the cycle; confirm that the chosen equipment is able to operate within the identified parameters; use biological indicators to confirm that the parameters and expected lethality are in agreement; and continue to maintain and monitor the equipment and cycles to confirm conformance to the validated process.
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