Validated Die Sterilization

Cleaning is performed with a validated die sterilization process designed to remove any residual cutting oils on the dies. The process contains a purified water rinse and a final WFI rinse to assure a non-pyrogenic product. Validation includes testing to assure that there is no residual detergent or cutting oil remaining on the die post processing. A gas chromatography method has been developed for residual cutting oil. A protein assay, based on the biuret reaction, has also been developed to assess residual protein contamination associated with the re-use of tissue cutting dies, if required.

Our FDA-registered, ISO 13485 certified laboratories will perform all associated testing to support both validation and routine product release. This testing can include, but is not limited to biological indicator and product sterility testing, bacterial endotoxin testing, bioburden quantitation, detergent residuals, oil residual, sterilant residuals (EO), particulate quantitation, cytotoxicity, etc.

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