Validation confirms that an equipment or a product sterilization process results in sterility ‚ consistently. USP Section 1211 addresses the validation requirements for steam sterilization, as it pertains to validation. Processes addressed by the standard include reaching and obtaining a minimum temperature of 121° during sterilization; proving a 6-log reduction in microbial contaminants Biological kill) by the use of biological indicators; proving lethality of microbial contaminants by obtaining an F° of at least 12 minutes. Additionally, Sterility Assurance levels can be calculated to confirm the load patterns designed by the customer meet all of the requirements listed above.
Transcat develops sterilizer (autoclave) validation protocols, conducts testing and provides reporting for medical device, pharmaceutical, and biologic companies. We have the knowledge and expertise to assist businesses in the validation of steam sterilization, as well as evaluate load patterns and cycles to assist the customer with cycle development. We perform validations and revalidations services that address customized needs while working with your schedule and budget
Steam Sterilization of Autoclaves
Steam sterilization is a way of decontaminating manufacturing or laboratory items. This type of sterilization validation can be performed at 121°C to 132°C according to U.S. and international guidelines. Our sterilization team will:
Develop the validation protocol
Conduct sterilization testing
Compile data and assess results
Evaluate your biological indicators (if require)
Provide completed reports to meet regulatory requirements
Your quality assurance teams will have the opportunity to approve the customized protocol we have developed before we begin the testing cycles.
With a proven record of excellence in validation services, Transcat can provide reliable sterilization testing to confirm sterility is being achieved. We can help to ensure organizational compliance with industry standards for the sterilizing of reusable process and laboratory items. We invite you to request a quote from Transcat on this specialized service today.
Start a Live Chat session, or call us today at 800.828.1470 for additional information on our calibration services.