How are laboratory consumables sterilized?
Most single use devices are terminally sterilized by ethylene oxide gas, or gamma radiation, or electron beam radiation. The sterilization process must be present on the pre-sterilized product. By means of the cGMP medical device regulations, FDA has established some of the requirements for an acceptable sterility assurance program. More specific guidelines for validation of the sterilization processes are developed and published by AAMI in conjunction with ISO. When auditors come to your facility to discuss sterilization requirements, they usually want to see two things: 1) the original validation package that determined what type of sterilization is best and what dose is appropriate (for radiation), and 2) review of periodic dose audits for the same product. An initial validation study usually takes 6 to 8 weeks, and is done on the largest container size in a series of the same material. That qualifies all sizes of that material to accept the same dose. For gamma radiation, which we
