Sterility at Speed: Applying USP <72> and <73> with Controlled Organisms and a Risk-Based Design

[Article Title]

The pharmaceutical industry is embracing rapid microbiological methods (RMMs) to speed up sterility testing while meeting new regulatory standards. USP chapters <72> and <73> offer clear guidance on two proven technologies—CO₂ respiration and ATP bioluminescence—that detect contamination faster than traditional methods without sacrificing reliability. Using controlled organisms ensures consistent testing even with low-level contamination or complex products. Studies confirm these methods effectively identify a wide range of microbes, including hard-to-detect slow growers. Supported by a risk-based approach in USP <1071>, these rapid methods promise faster product release and improved sterility assurance, making them a compelling choice for modern pharmaceutical manufacturing.

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