The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
This whitepaper examines how rapid sterility testing technologies enhance efficiency, reduce time-to-results, and improve overall product safety while maintaining regulatory compliance. It reviews a case study to gain further insight into the accuracy of rapid sterility testing solutions. Want to...
This article discusses how modern microbial methods (also known as rapid microbiological methods or alternative methods) can support a contamination control strategy, which is a requirement of EU GMP Annex 1, Manufacture of Sterile Medicinal Products. The article is the...
This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. It is the result of a collaboration among authors (listed below) from different industry working groups that joined forces in 2021 to support the...
