,"Australia’s Therapeutic Goods Administration (TGA) has issued updated instructions for disinfectant and sterilant testing to ensure compliance with Therapeutic Goods Order (TGO) 104 (2019) on product quality, safety, and efficacy. The guidance covers both hospital- and household-grade disinfectants, outlining test organisms, inoculum densities, and performance criteria.
It provides detailed methods for antimicrobial efficacy, stability, and shelf-life testing, including accelerated studies and compatibility checks. Disinfectants must meet specified log reduction standards for bactericidal, fungicidal, virucidal, tuberculocidal, and sporicidal claims, referencing recognized methods such as AOAC, ASTM, and EN standards.
The guidance also includes test procedures for wipes, sprays, residual activity, and airborne disinfection, ensuring testing is performed under GMP or ISO/IEC 17025 conditions to maintain regulatory compliance and product reliability."
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