Study Outline
BIOLOGICAL INDICATOR POPULATION VERIFICATION
An in-house biological indicator (BI) population verification will be performed on each lot number of biological indicator used, according to the current Nelson Laboratories, Inc. standard operating procedure (SOP).
STEAM STERILIZATION VALIDATION
Spore strips of Geobacillus stearothermophilus will be placed in or on devices in places expected to be most resistant to steam penetration and thermal conductance. Each device will be wrapped in two layers of 1-ply, polypropylene wrap, or sealed in a sterilization pouch (if applicable). The pre-processing weights of each wrapped device will be recorded. Each device will be placed in the "cold" spot of the gravity or prevacuum steam sterilizer. The devices will be sterilized for a total of three half-cycles according to specified parameters . Following the completion of each half-cycle the devices will be removed from the sterilizer and the post-processing weights of each wrapped device will be recorded. The pre-processing and post-processing weights should not differ by more than 3%. The spore strips will be removed from the devices and aseptically transferred into sterile tubes of media. Positive, negative, and environmental controls will be performed. The tubes and controls will be incubated at 55-60 ºC for 7 days and observed for growth of the challenge organism.
References
AAMI TIR No. 12 - 1994. Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers. Association for Advancement of Medical Instrumentation, Arlington, VA.
Food and Drug Administration. 1996. Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Office of Device Evaluation, FDA, Washington, D.C.
United States Pharmacopeia 27 & National Formulary 22. 2004. United States Pharmacopeial Convention, Inc., Rockville, MD.
ANSI/AAMI ST46-2002. Good Hospital Practice: Steam Sterilization and Sterility Assurance. ANSI/AAMI.
EN 554 - 1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat. European Committee for Standardization, Brussels, Belgium.
ANSI/AAMI ST8-2001. Hospital Steam Sterilizers. ANSI/AAMI.
ANSI/AAMI/ISO 11134 - 1993. Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization. ANSI/AAMI/ISO.
Sample Requirements
Nelson Experts:
- Jason Pope 801-290-7883, 800-826-2088
- Emily Mitzel 801-290-7899, 800-826-2088
- Eric Clark 801-290-7882, 800-826-2088
