Sterility and Alternative Sterility Testing

This presentation discusses requirements for sterility testing as per USP 71 and 797. Attendees gain detailed insights into sterility test methods, a clear understanding of rapid sterility testing, and an exploration of the review of Certificates of Analysis.

[@Victoriawakeup]

Hi we use DI but using syringes to transfer from product container to media - would you still class this as higher risk than filtration even though its closed system?
Also I've spoken with tech advisor from a major sterility test consumable supplier and they advised no issues with large volumes over filters but need validate. I've never heard of an upper limit of volume that you can filter? Thanks

[@ARLBioPharma]

Thank you for your question. In performing direct inoculation testing as you described, since there is a transfer step between the sample and the media jar, where the syringe / needle is outside of either container, it wouldn’t be considered a “closed system”. However, with proper aseptic technique and environmental controls in place, this process can be performed in an aseptic manner.
Regarding volumes of sample per filter, there is no defined maximum sample volume which can be passed through a filter, assuming no clogging / filterability issues are observed. However, USP does state for testing of aqueous solutions to not exceed rinsing with “5 times 100 mL per filter, even if during method suitability, it has been demonstrated that such a cycle does not fully eliminate the antimicrobial activity.” As you mentioned, proper validation (method suitability) is required to demonstrate the chosen method is effective for the formulation and sample volume being tested. Please contact us if you have additional questions: [e-mail].

[@Victoriawakeup]

@@ARLBioPharma thanks for getting back to me. I'll drop you an email as I have some more questions.

[@Victoriawakeup]

@@ARLBioPharma confusion re the closed system aspect as with filtration one must still use a needle from a sterility test kit? 🙄