 Dr. Jerry Nelson Nelson Laboratories Chief Science Officer Visit Website |
Jerry R. Nelson, Laboratory Director at Nelson Laboratories, has a PhD in microbiology and immunology from the University of Utah. He is a member of numerous standards-writing committees and associations, including the New York Academy of Sciences, American Society for Quality, Parenteral Drug Association, American Society of Testing and Materials, Association for Advancement of Medical Instrumentation, Society for Pharmaceutical Engineering, and the American Society for Microbiology. In addition to having published dozens of articles, he is also an adjunct professor of bioengineering at the University of Utah and an adjunct assistant professor of microbiology at Brigham Young University. Jerry was named by MPMN's sister publication, MD+DI, as one of the Top 100 Notable Individuals in the medical device industry.
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Sterilization and Biocompatibility Q&A
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We are conducting taste experiments with sucrose, saline, quinine, citric acid, and MSG solutions and are exploring different methods to prepare or sterilize the solutions. We will then have the contents tested for various contaminants at 30-, 60-, and 90-day intervals. However, our analytical lab is not sure what standard to use as a cut point for stopping the analysis. Any suggestions?Answered August 24th, 2010 by Expert:There are at least four issues involved here: How long does the product maintain the desired organoleptic properties? How long will the packaging maintain the desired state (carbonation, sterility [barrier?]? How long are the preservatives supposed to be effective? What is the desired or labeled shelf life?
The study should be as long as necessary to cover the shortest of the product requirements. For example, if the product changes color, taste, etc. at 180 days, it should be tested to 180+ days. If the package maintains product integrity for only 120 days, 120+ days should suffice. If there is any possibility that the product will be on the shelf longer than the organoleptic or microbial data support, shelf-life labeling for the validated interval would be appropriate. All studies should be longer than the labeled shelf life or longer than the shortest interval that the product safety test data support.