USP <797> <71>
All sterility testing is done in accordance with USP <797> and <71> whenever possible. The testing apparatus and media is determined by the sample matrix, container, or batch size as dictated by the USP requirements.
Sample testing will begin as soon as possible after the sample arrives and is logged in. Depending on the number of samples received, some may be held to the following day. Test apparatus will then be observed for growth regularly, except weekends and holidays. If any growth is observed at any time point, the customer will be notified immediately by phone.
All sterility results are reported on Pass/Fail basis. After 7 days a Preliminary Sterility Report will be sent or posted to the customer. After 14 days of incubation, the Final Sterility Report will be sent or posted to the customer.
We will not release a final, signed report until the 14 day incubation period has been met.