SaniSure is fully committed to providing gamma irradiated Single Use Assemblies and Systems. SaniSure single-use assemblies are assembled and packaged in an ISO Class 7; 10,000 cleanroom. We can provide gamma irradiation sterilization with a 10–6 SAL (Sterility Assurance Level), a one millionth probability of microbial survival. SaniSure provides full lot traceability that identifies the manufacturing date, part numbers, quantities, and origin of the components. We provide and maintain all required documentation, including complete validation documents and certificates of conformance and sterility.
SaniSure’s preassembled, sterilized, and validated single use systems help improve safety, reduce labor costs, improve production efficiency and overall production costs by eliminating cleaning validation, improving ease of implementation and speed to market.
|