Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing
The adoption of rapid sterility testing has significant benefits to the pharmaceutical industry; providing early notification of control drifts, a non-subjective answer to the sterility test and a faster time to product release. However the challenges of adoption can be daunting. By enhancing the benefits of regulatory interactions in the development phases, a complex post-approval regulatory change can be mitigated, however with limited material available, the outlined strategy provides a robust way forward to adopt rapid sterility and capture the benefits.
AstraZeneca considered the global operations of a major pharmaceutical company in the adoption of rapid sterility. Utilising risk assessment tools and a holistic overview of pharmaceutical clean room flora, a representative panel of global microorganisms was selected. Variability between product, consumables, organisms origin & status and testing sites was factored in.
Focused studies were performed and data will be shared to provide an outline of the operating range that has been verified for the ATP Bioluminescence based sterility test.
The presentation will outline a vast & powerful data set which supports the robustness of the rapid sterility test, to enhance our product understanding. Additional data was leveraged in time to result studies for “challenging organisms” such as slow growers.