Sterile Die Packaging

Sterile die packaging is performed and validated consistent with ISO/ANSI/AAMI 11607-1 and ISO/ANSI/AAMI 11607-2 standards. Dies can be single packaged or double packaged to promote aseptic transfer into a cleanroom die cutting environment. The selected packaging system will be based on your requirements. If the die is to be sterilized, the packaging system will be designed to be compatible with the chosen sterilization modality.

SRD and our FDA-registered, ISO 13485 certified laboratories can work with you to select and deliver the most appropriate and cost-effective packaging system for your application. Additionally, we can coordinate simulated shipping and distribution tests, per ASTM 4169, if desired.

Packaging options include:

  • Sterilization Wrap – CSR (Central supply Wrap). For example the Kimberly Clark KimGuard or KimGuard One-Step. The product is wrapped (or double wrapped) using an envelope folding technique as specified in AAMI ST-79.
  • Pouch – the product can be sealed in a paper-to-film or Tyvek r-to-film pouch. Sealing is performed using validated parameters on a water-cooled Vertrod sealer.
  • Poly Bag – the product can be sealed in a plastic bag, of desired thickness, using validated sealing parameters.

Sterilized Die

 

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