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Sterility Testing

Meaning

Sterility Testing is a critical, mandatory quality control procedure performed on compounded medications, biological products, and medical devices to confirm the absolute absence of viable microorganisms, including both bacteria and fungi. This essential clinical assay ensures the safety of all parenteral products, such as injectable hormonal therapies, preventing the severe risk of systemic infection upon patient administration. Strict adherence to pharmacopeial standards and regulatory requirements is required for all aspects of this testing.