 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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How can I find out whether the silicone grade I am using is autoclavable or not, especially if autoclaving is not mentioned in the datasheet?Answered May 10th, 2011 by Expert:Silicone rubber is routinely sterilized with steam and occasionally with dry heat. While all the silicone that I am familiar with does well with steam sterilization, there are some potential problems that you need to ensure do not occur. I would suggest you do performance tests before buying much of the material.
You can also look up silicone rubber in AAMI TIR 17, a great reference that describes a wide range of materials, modes of sterilization, and their associated effects. AAMI TIR 17:2008 is good for this kind of information for those who are not polymer scientists. It states that silicone can range widely from poor to excellent in its ability to withstand steam sterilization (autoclaving). Resterilization up to more than 10 cycles is likely acceptable. Autoclavability depends largely on the grade of silicone you have. The best thing to do at this point is to try a cycle and see how it works.