Is There a Numerical Relationship Between Time and Temperature for Steam Sterilization?
Medical Product Manufacturing News (MPMN) turned to Nelson Laboratories’ Founder and Chief Science Officer, Dr. Jerry Nelson, as an expert source to answer questions about sterilization and biocompatibility for its online “Ask the Experts” section.
Here is the most recent question posed to Dr. Nelson:
Question: When using steam or autoclave sterilization, is there a numerical relationship between time and temperature? The product in question is 100% LIM silicone.
Dr. Nelson’s Answer: There is not a direct comparison between time and temperature for steam sterilization for 100% LIM silicone material. Time and temperature are based on the complexities of the device, material, packaging, etc. We recommend validating the common sterilization cycles as performed in health care facilities and as outlined in ANSI/AAMI ST79:2006 and A1:2008, A2:2009.