ABSTRACT
In the sterilization area, 100 percent ethylene oxide sterilization programs are being optimized, and heated aeration is being employed to expedite removal of gas from the product, making faster turnaround times possible. The Food and Drug Administration has published a guideline that allows manufacturers to validate a reduced biological indicators incubation time frame. The incubation time for biological indicators may be reduced in medical device sterilization processes from the standard seven or more days, provided, at a minimum, the validation studies demonstrate that the revised number of days of incubation are sufficient for product release according to the testing methodology described. Remember to document medical device manufacturers’ validation using a typical validation format of protocol, data analysis and final approved report. All Standard Operating Procedures referencing the BI incubation time should be revised and approved before implementation of the new incubation time frame.
