Steam Sterilizer Validation Services
Validation confirms that an equipment or a product sterilization process results in sterility ‚ consistently. Processes include reaching and obtaining a minimum temperature of 121° during sterilization; 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.
Sierra 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.