Sterility Assurance Laboratories, Inc.

Sterility Assurance Laboratories, Inc. is a contract testing and validation laboratory specializing in sterilization services and microbial testing for medical device manufacturers. The company provides comprehensive sterilization validation and sterility testing services for medical devices processed via ethylene oxide (EO) and other sterilization methods. Core service offerings include Medical Device Sterilization support, Sterilization Validation studies, Sterility Testing (USP <71>), Bioburden determination, and Microbial Limits testing. Additionally, SAL offers specialized analytical services including Ethylene Oxide Residuals testing and Dialysis Water and Dialysate Testing, supporting both device manufacturers and dialysis facility operations. The laboratory serves medical device manufacturers requiring regulatory-compliant testing to support FDA submissions, 510(k) clearances, and ongoing quality assurance. Services are aligned with industry standards including USP, ISO, and FDA guidance for sterilization validation and microbial control. The company operates a full-service laboratory facility capable of supporting device development, validation, and quality testing throughout the product lifecycle.