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
In this Pharma Matters Q&A, Amina Rahmoune, Laboratory Operations Manager, Sterility Assurance, Nelson Labs, explains how sterility testing in cleanrooms and isolators must be evaluated in the context of how effectively these environments support contamination control, not simply whether they...
Through this conversation, Christine Walton helps clarify the intent and application of USP <1119> and <1119.1>, positioning them not as prescriptive rules but as flexible, risk-based frameworks for modern bioburden testing. She emphasizes that true compliance and control come from...
Sterility assurance is of utmost importance for medical devices that come into contact with body cavities. However, bioburden and sterility are linked to a third concern—pyrogens—which may not be adequately addressed solely by ensuring device sterility. Pyrogens and Endotoxins: Understanding...
Thor Rollins, consulting manager, and Audrey Turley, research scientist, have been invited to speak at the joint conference of the Association of Analytical Communities Southern California Section (AOAC SCS) and Food and Drug Agency (FDA) 2016 Spring Conference. Rollins and...
Scott Sutton, PhD, was a well-respected and influential thought leader in the microbiology industry. He was a consultant and trainer in CGMP, investigations, environmental monitoring, and contamination control for pharmaceutical companies for over 30 years. He gave many presentations on...
