NEW STERILIZATION METHODS
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 INTRODUCTION
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.
2 POINTS TO CONSIDER FOR A NEW STERILIZATION METHOD
The major steps in the implementation of a new sterilization method include the following:
Elimination of any established method through experimental evidence and/or comprehensive literature review of any materials used
A literature review to identify supportive information on the proposed method
Identification and confirmation of reproducible lethality against a broad range of microorganisms, including bacterial spore-formers
Identification and definition of critical process parameters necessary to ensure sufficient lethality. The effective range of these parameters should be explored to identify necessary conditions for the proposed sterilization process. Among the parameters to be considered, depending upon the nature of the process under consideration, are process dwell time, temperature, concentration, energy or power, and relative humidity. This evaluation should include positive and negative controls to ensure that the proposed method is in fact responsible for microbial destruction.
The selection of a biological indicator (usually a spore-forming microorganism) with increased resistance to the sterilization method
Evaluation of the proposed method against anticipated bioburden microorganisms and comparison of relative resistance of the bioburden microorganism to that of the chosen biological indicator
The identification of in-process and/or post-process measurements and/or analysis that can reliably confirm the effectiveness of the proposed sterilization process.
Where the proposed new method is used for materials intended for human and/or veterinary use, the relevant regulatory authorities should be contacted to secure their acceptance before either investigational or clinical usage. Validation of the proposed new method should be completed before use on a commercial basis.
