The control of microorganisms in manufacturing processes and environments is crucial for enhancing the safety and efficacy of pharmaceutical products. In the past two decades, significant advancements have been made in modernizing the test for bacterial endotoxins (BET) and sterility test, due to the development of novel technologies such as recombinant Factor C (rFC) and rapid microbiological methods (RMM).
Recent progress is further evident by adoption of these technologies as compendial methods in Europe, and approval of parenteral medicines using these methods for release testing by multiple global regulatory authorities.
This workshop aims to provide insights into alternative methods, current compendial and regulatory trends worldwide, present case studies showcasing successful implementations of these methods and discuss their impact on advancing quality control processes.
Welcome and opening remarks by bioMerieux
Bacterial Endotoxin Testing – Progressive Science and Sustainability
Transforming Sterility Testing in Australia: CBE Pure Solutions' Pioneering Journey