About SA Labs
Sterility Assurance Laboratories, Inc. (SA Labs) was established 2000 to support the sterile product testing needs of domestic medical device manufacturers with operations in Northern Mexico. SA Labs currently supports customers worldwide with a team of associates that has many years of experience in healthcare manufacturing for Fortune 500 companies.
We offer microbiological and chemical testing services to industry specializing in the types of tests required to validate and confirm the sterility and safety of medical devices, pharmaceuticals, and the various types of water that exist for “pharmaceutical purposes.” This includes quantitative bioburden and microbial assessments, sterility testing of both sterile products and BIs, and residuals testing for EO sterilized products.
Other services we perform include bacterial and mold organism identifications. We write and perform sterilization validations for EO, gamma, and steam sterilization processes, including annual revalidations for EO and steam and quarterly dose audits for radiation processes. SA Labs offers NIST traceable metrology services calibrating various devices for temperature, relative humidity, and pressure.
We are is headquartered in Tucson, Arizona with a satellite facility in Adams County, Pennsylvania. SA Labs, Inc. is an FDA registered facility that also holds an ISO 13485 :2003 Certificate of Registration through Orion Registrars.
Please contact us for a consultation regarding your specific needs and objectives.
- Use the form on our Contact Us page.
- Or , call us directly at (520) 628-7103.
We offer fast turn-times on customized protocols with an outstanding history of customer service.