The final section of USP that is related to biological indicators and sterilization types is <1229.12>. This section addresses the concept of new sterilization methods. According to USP, “Sterilization processes are developed for the elimination of viable microorganisms while preserving the essential physical, chemical, and biological properties of the materials subjected to them. Where this cannot be accomplished by the sterilization methods described in Sterilization of Compendial Articles <1229>, it may be possible to sterilize by using a proposed method not commonly used. When doing so, it is the end user’s responsibility to demonstrate that the proposed new method can be used safely and effectively”.
USP identifies steps that must be taken when you choose to utilize a new method for sterilizing. These steps include confirming the results are reproducible, identification of process parameters, selecting an appropriate biological indicator, and to identify measurements used to confirm effectiveness of the process. It’s also necessary to alert the regulatory authorities if your materials are intended for use with humans and/or animals.
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