Medical Die Sterlization

Sterilized DieSteel Rule Diemasters and our FDA-registered, ISO 13485 certified laboratories have the combined experience and expertise to deliver a clean, packaged and sterilized die, manufactured to your specifications, and meeting or exceeding your 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 conduct all product specific release testing to meet your medical and pharmaceutical requirements, i.e. sterility testing, bacterial endotoxin (LAL) testing, particulate testing, and cytotoxicity.

Cutting stainless steel blades used in our medical grade dies are custom made for Steel Rule Diemasters. Our blades go through a unique sterilization processes that other die shops do not use, in order to achieve the highest level of sterility when used in your die cutting press. This, along with different bevels, stainless grades, and body hardness means we have the right stainless steel die cutting blade for your application.

Steel Rule Diemasters uses Lexan® which is compatible with Autoclave cleaning procedures (see Lexan® data sheet), whereas our competition often uses acrylic (see data sheet). Check with our competition and see if they are using Autoclave and Gamma Irradiation safe products, or other die sterilization modalities listed below.

Die Sterilization Modalities

Several die sterilization modalities exist and may include these options depending on your needs:

Sterile Die Packaging

Validated Die Sterilization

Autoclaving Sterilization

Ethylene Oxide Gas Sterilization

Radiation Sterilization

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