 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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Our company manufactures helium leak-detection equipment and supports many medical device manufacturing companies in the practice of leak detection. Is there an accepted standardized industry specification that discusses testing methodology, or something that is used as a guideline for the nondestructive leak detection of medical devices?Answered March 3rd, 2011 by Expert:The Parenteral Drug Association (PDA) has a technical monograph (#27) on Pharmaceutical Packaging Integrity that cites helium mass spectrometry methods. There are dozens of published articles that compare helium leak methodology to microbial ingress for testing container closure integrity and for pharmaceutical packaging. Most of the published articles are in the PDA Journal of Pharmaceutical Science and date from the 1980s to the present. Other standards that could be referenced include the following:
- ASTM E493-06—Standard Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Inside-Out Testing Mode
- ASTM E499-95 (2006)—Standard Test Methods for Leaks Using the Mass Spectrometer Leak Detector in the Detector Probe Mode
- ASTM E908-98 (2004)—Standard Practice for Calibrating Gaseous Reference Leaks
- ASTM E1603-99 (2006)—Standard Test Methods for Leakage Measurement Using the Mass Spectrometer Leak Detector or Residual Gas Analyzer in the Hood Mode