Sterility testing remains a foundational element in verifying the safety and quality of compounded sterile preparations (CSPs). ARL Bio Pharma offers three distinct sterility testing methods—each validated and designed to support USP <797> compliance while accommodating operational variability in turnaround time and sensitivity. These testing options allow pharmacies and outsourcing facilities to align microbial detection strategies with production needs and regulatory expectations.
- USP <71> Sterility Method: This compendial method is the industry standard and required by the FDA for many drug products. It uses membrane filtration or direct inoculation followed by a minimum 14-day incubation to detect microbial growth. Ideal for CSPs requiring extended shelf life and formal regulatory compliance.
- Celsis ATP Bioluminescence Method: A rapid-growth method that detects microbial ATP using bioluminescence. This test delivers results in approximately six days and is validated per USP <1223>. It offers an efficient alternative for faster batch release while maintaining rigorous quality standards.
- ScanRDI (Solid Phase Cytometry) Method: This non-growth-based method uses fluorescence detection to identify and count viable microorganisms in sterile samples. It provides same- or next-day results (as fast as four hours) and is useful for contamination investigations or expedited product release. While not a substitute for USP <71> in all cases, it is a valuable tool for risk-based quality strategies.
All three methods are supported by ARL’s ISO/IEC 17025:2017-accredited laboratory systems. Their technical team validates and performs each test according to FDA and USP guidance, ensuring data integrity and defensibility. By offering a range of sterility testing platforms, ARL enables compounders and 503B outsourcing facilities to integrate microbial detection into both routine operations and rapid-response scenarios.
