Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological

The last decade brought an impressive list of technological advances, ensuring the sterility and quality of a myriad of new drug and biological products, in addition to medical devices. These advances bring new treatments, improve quality of life and extend life expectancy for millions of patients. This paper summarizes some of those new technologies and focuses on a few examples that clearly enhance sterility assurance in the manufacturing of pharmaceuticals.

Author
Dr. Claudio Denoya

Claudio Denoya, Ph.D., is a Senior Applications Scientist, Life Sciences Division, at Particle Measuring Systems. His current main focus is in Environmental Monitoring to control and improve aseptic processes in the pharmaceutical and related industries. He is also a member of the Advisory Council for the National Center for Therapeutics Manufacturing at Texas A&M University. Dr. Denoya has recently been selected as an Expert Panel member in the Modern Microbiological Methods chapter of the United States Pharmacopoeia (USP).