INTRODUCTION
Sterilization relies on the reliable destruction of microorganisms present in/on the materials being sterilized. Information regarding the resistance of the bioburden to the sterilization process (with the possible exception of overkill processes) is essential to confirm the efficacy of the sterilization process (see Sterilization of Compendial Articles 〈1229〉) and is a required component of a parametric release program (1,2). Spores exhibit inherent and varying levels of resistance to all modalities of sterilization. There are limited resistance data available for some spore-forming and pathogenic microorganisms; however, for the vast majority of microorganisms (including most spores), there is no data available regarding their susceptibility to sterilization processes (3). Furthermore, wild type microorganisms and spores derived from manufacturing processes are likely distinct from their reference-standard culture-collection counterparts and may exhibit differing levels of resistance to sterilization processes (3). This chapter outlines methods that can be used to determine the presence of spores and the resistance of microorganisms, spores, and biologic indicators (BIs) to moist heat sterilization, including variations of the boil test mentioned in Moist Heat Sterilization of Aqueous Liquids 〈1229.2〉 and Monitoring of Bioburden 〈1229.3〉. The included methods are not intended for use in radiation sterilization where the procedures described in ISO 11137 are to be followed (4). The methods described are arranged in order of increasing robustness.
GENERAL PROCEDURES
Carry out the tests under conditions designed to avoid extrinsic microbial contamination of the materials to be examined. The precautions taken to avoid contamination must be such that they do not affect the microorganisms that are recovered in the test. If the product to be examined has antimicrobial activity, insofar as possible, this should be removed or neutralized. If inactivators are used for this purpose, their efficacy and their nontoxicity to the microorganisms must be demonstrated. If surface-active substances are used for sample preparation, their nontoxicity to the microorganisms and compatibility with any inactivators used must be demonstrated.
Preparation of the Sample
The method for sample preparation depends on the physical characteristics of the pre-sterilization material to be tested. For aqueous products, 10-mL samples should be taken from closed primary containers. For solid, water-insoluble, or immiscible products, follow the sample preparation details provided in Microbial Enumeration Tests 〈61〉. Samples should be aseptically transferred (either from 1 unit or composite) to sterile, screw-capped tubes. A minimum of 10 samples should be tested for spore presence/absence or moist heat resistance estimation.
Source from USP and Please refer to USP for details:https://online.uspnf.com/uspnf/document/2_GUID-9426A9DA-F9A0-4E48-A408-33406AC7353B_10101_en-US?source=TOC
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