Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Per regulatory guidelines, the implementation of an environmental monitoring program is required to comply with good manufacturing practices and...
This application notedetails specificity experiments for the six species listed in the USP <71> guidelines for sterility testing, as well as category 2 bacterial and fungal species. It illustrates how the SteriSEQ Rapid Sterility Testing Kit can be used for in-process testing to help ensure...