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Packaging and Storage

All BioMed allografts are packaged and processed under strict quality standards to ensure biological safety, structural integrity, and ease of use in the surgical setting. Each product is triple packaged—sealed within two non-sterile outer layers and a sterile inner pouch—to preserve sterility until the time of use.

Opening and Preparation

  1. Outer Packaging
    • Peel back the foil dust cover and remove the tissue sample while keeping the Tyvek layers intact.
  2. Aseptic Transfer
    • Peel open the Tyvek secondary cover to expose the primary sterile pouch, and aseptically hand the inner pouch to the scrub nurse for sterile presentation.
  3. Product Rehydration
    • Inside the sterile field, open the inner pouch and remove the allograft.
    • Rehydrate in sterile saline solution for at least 30 minutes prior to implantation, unless otherwise stated in the IFU.

Instructions For Use

Included with your product are detailed Instructions for Use (IFUs). These documents provide essential information on preparation, application, and handling to ensure safe and effective use.

Storage Requirements

Temperature Range:

  • Store between 4 °C and 40 °C (39 °F and 104 °F). This range provides optimal protection against temperature-related damage:
    • Below 4 °C (39 °F) the packaging materials may stiffen, increasing risk of cracking or seal compromise.
    • Above 40 °C (104 °F) excessive heat may dry or denature tissue proteins, potentially affecting graft performance.

Environmental Conditions:

  • Store in a cool, dry area away from direct sunlight or heat sources.
    Do not refrigerate or freeze unless specifically indicated for that product type.
  • Avoid storing near autoclaves, radiators, or in vehicles without temperature control.
  • Short-term temperature fluctuations during shipping are acceptable within the validated range.

Important Handling Notes

  • Do not use if any package layer appears opened, punctured, or damaged.
  • Do not re-sterilize. Each product is terminally sterilized and validated prior to release.
  • Always verify product integrity, expiration date, and lot information before use.
  • Refer to the individual product’s Instructions for Use (IFU) for any specific requirements regarding rehydration, handling, or implant technique.