The current 14-day incubation period required for USP<71> sterility compliance means many sterile compounds will have a severely limited shelf life. Compounding pharmacies must meet the challenge of providing safe medications that are produced using validated methodology or risk failing an FDA inspection.
Eagle Analytical offers an FDA-accepted alternative to official compendial sterility test methods. The ScanRDI® Rapid Sterility Test detects viable microbial cells down to one microorganism without the need for growth or cell multiplication. This USP<1223>-approved style of testing provides USP<71>-compliant results in just one day.