Die Sterilization

We can work with you to coordinate the delivery of clean, packaged and sterilized dies that meet your specifications as well as FDA requirements and expectations.

Steel Rule Diemasters has developed a strategic working relationship with FDA-registered, ISO 13485 certified consulting and contract laboratories to provide validated die cleaning, packaging and sterilization processes compliant with FDA and ISO standards and guidelines. This laboratory can also conduct all product specific release testing to meet your requirements, i.e. sterility testing, bacterial endotoxin (LAL) testing, particulate testing, and cytotoxicity.

Several sterilization options are available depending on the die material and packaging selected. Our FDA-registered, ISO 13485 certified laboratories will validate the selected sterilization process to the current FDA and industry recognized standards. These sterilization modalities include: 

Learn more about die sterilization on the blog.

Our certified laboratories will perform all associated testing to support both validation sterilization 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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