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Bioburden Testing

April 1, 2026

Isolators vs. Cleanrooms for Sterility Testing: Considerations for Regulatory and Operational Efficiency

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...

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November 5, 2025

USP 1119 and 1119.1: The Future of Risk-Based Bioburden Testing Standards

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...

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June 9, 2023

Are sterile devices microbiologically safe? Unraveling the relationship between pyrogens, bioburden, and sterility

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...

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March 10, 2016

Nelson Labs Experts Invited to Present at Joint Conference

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...

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November 13, 2015

Tribute to Dr. Scott Sutton; Review of Bioburden Contamination Control

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...

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