Compare CDMOs with GMP microbiology laboratory capabilities for sterility testing, endotoxin analysis, bioburden, and environmental monitoring.
Microbiology testing ensures pharmaceutical products are free from harmful microorganisms and endotoxins. For sterile products (injectables, ophthalmic), sterility testing and endotoxin analysis are critical release tests. For non-sterile products (oral, topical), bioburden limits and specified organism absence testing protect patient safety.
Environmental monitoring is the ongoing surveillance component of microbiology. CDMOs must continuously monitor manufacturing areas for viable and non-viable particulates, surface contamination, and personnel contamination. Trending environmental monitoring data provides early warning of contamination control issues before they affect product quality.
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