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
The MPN method can be useful when traditional bioburden tests won’t work, but it must be clearly understood and carefully implemented. Read the Full Story in MD+DI
When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device manufacturer. Nelson...
