Demonstrating Equivalency and Limit of Detection for a Rapid Sterility Method via ATP-Bioluminescence
Demonstrating Equivalency and Limit of Detection for a Rapid Sterility Method via ATP-Bioluminescence Now, more than ever, the pharmaceutical industry needs a rapid sterility test method. However, the validation of an alternative rapid technology proves too challenging for many QC micro labs. This reality is changing through the ongoing collaboration and sharing of validation strategies. Utilizing an amplified ATP bioluminescence detection method, this presentation will share how equivalency, specificity and limit of detection was demonstrated against the compendial sterility method…