The process is a series of baths that:

• Preserves the biomechanical integrity of the graft
• Removes antigenicity, lowering the risk of graft rejection
• Inactivates conventional and unconventional viruses to prevent transmission of infectious agents
• Extends shelf life and promotes ease of handling by making grafts storable at room temperature

Post recovery allografts contain fibers, minerals, fats, and bioburdens, from the graft. The process also uses single-unit processing to avoid potential cross-contamination and increase tissue safety.

Donor Screening--First Priority

Thorough pre-recovery donor screening is the foundation of the Tutoplast process. To meet the stringent safety requirements for allograft products and to insure quality control, donor screening involves:

• Donor selection by physicians
• Survivor interviews for collection of donor medical, demographic and social history
• Double serum testing using CLIA-lab donor protocols
• All tissue is fully traceable. Individual reference samples are stored for 15 years, allowing re-examination, if necessary

Delipidization

• Grafts are bathed in acetone and agitated with ultrasound.
• Removes fats that may interfere with healing.

Inactivates viruses and prions.

• Prepares tissue so subsequent steps more effectively penetrate the graft.

Solvent Dehydration and Viral Inactivation

• Grafts receive a series of seven acetone baths.
• Extracts all water from the graft making graft storable at room temperature for five years.
• Preserves the dense collagenous fiber structure of the graft, retaining the original tissue strength.
• Insures inactivation of any remaining prions or viral agents exposed during osmotic bath.

Osmotic Contrast Treatment

• Unique to the Tutoplast process, grafts receive a two-step alternating bath of distilled water and saline.
• Disrupts bioburden cell wall integrity and exposes intracellular material for removal or destruction in this subsequent step.

Sterilization

• Grafts receive low-dose gamma irradiation (17.8kGy), in a narrow rotating sterilization system.
• Minimizes irradiation to insure biomechanical integrity of allograft.
• Eliminates reliance on aseptic process and collection methods.
  Insures sterility following cutting and packaging.

Oxidation Treatment

• Grafts are bathed in a hydrogen peroxide (H₂O₂ ) wash.
• Destroys remaining proteins in the graft, minimizing the risk of graft rejection.
• Inactives any remaining viruses exposed during osmotic bath.