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With Masteflex Single-Use, you will no longer have to validate the cleaning and sterilizing of your bioprocess assemblies. The purchase of a preassembled, sterilized, and validated system shifts the principal burden of validation to the supplier. That is why it is important to be sure your supplier uses only the most reliable brand name products and adheres to strict, well-established protocols in the sterilization process.
Masterflex Single-Use assemblies are manufactured in a Class 10,000 cleanroom. The assembly facility is ISO-13485 certified, cGMP compliant and FDA registered. We offer gamma irradiation sterilization with a 10–6 SAL (Sterility Assurance Level), a one millionth probability of microbial survival an full lot traceability that identifies the production site, manufacturing date and origin of the components. We also provide and maintain all required documentation, including complete validation documents and certificates of conformance and sterility.