The medical device industry is seeing a rise in regulatory scrutiny around microbial QC management and endotoxin testing. With this increase, a thorough understanding of the requirements of <USP 161> and ANSI/AAMI ST72:2011 is crucial for manufacturers of injectable and implantable devices, as they provide guidance for maintaining the long-term safety of their products, mitigating risk, improving QC lab throughput, and understanding inconsistencies.