Revised USP <1072> on Disinfectants and Antiseptics

The updated USP Chapter <1072> offers guidance on selecting and validating disinfectants, with particular relevance for firms inspected by global regulators, including the FDA. It outlines the need for comprehensive cleaning and disinfection programs in pharmaceutical facilities to prevent both microbial and chemical contamination—applicable to sterile and non-sterile products. The chapter stresses that disinfectants must not introduce harmful residues and highlights links to USP <1115> on bioburden control.

The revision reinforces cleanroom practices, emphasizing the removal of residues and microorganisms through agents, chemicals, and mechanical methods. Core topics include disinfectant selection, proof of efficacy (bactericidal, fungicidal, sporicidal), GMP application, and safety considerations.

Key changes include: removal of definitions (now in <1117.1>), new methods for room decontamination using vaporized hydrogen peroxide or chlorine dioxide, expanded selection criteria, and updated disinfectant challenge test requirements (including a 2-log reduction for fungal spores). Guidance on in situ qualification, coupon testing, and personnel safety has also been added.

23-08-2025