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Tutoplast® Tissue Sterilization Process

Tutoplast® Tissue Sterilization Process

The Tutoplast® Tissue Sterilization Process is a chemical sterilization methodology originally developed more than 50 years ago by Tutogen Medical to sterilize and preserve tissue for implantation. Membrane and soft tissue augmentation grafts, as well as bone implants, sterilized through the Tutoplast Process are used in hernia repair, dental and other procedures.

How does the Tutoplast® Process work?

Osmotic, oxidative and alkaline (if indicated) treatment break down cell walls, inactivate pathogens and remove bacteria. Solvent dehydration allows for room temperature storage of tissue without damaging the native tissue structure. Low dose gamma irradiation ensures Sterility Assurance Level (SAL) 10-6 of the final packaged graft.

Alkaline Treatment

Alkaline Treatment
Removes cells and lipids which interfere with healing.

Osmotic Treatment

Osmotic Treatment
Disrupts cell membranes to allow easier removal of cellular components.

Oxidative Treatment

Oxidative Treatment
Removes immunogenic structures, enveloped and non-enveloped viruses.

Solvent Treatment

Solvent Treatment
Removes water from tissue, preserves the natural tissue matrix and allows for a five-year shelf life.

Irradiation Treatment

Irradiation
Low-dose irradiation produces a terminally sterilized graft, while preserving structural integrity.

Images depict dermal processing.

Pathway to Implantation

After consent/authorization for donation is obtained, donor history screening and laboratory testing is performed in accordance with U.S. Food and Drug Administration (FDA) regulations and American Association of Tissue Banks (AATB) Standards.


1

Donor Screening

  • Donor risk assessment
  • Medical / hospital record interview
  • Medical examiner/coroner’s report (when provided)
  • Laboratory, pathology & radiology reports (when available)

2

Infectious Disease Testing

  • HIV-1/HIV-2 Antibody
  • Hepatitis C Virus Antibody
  • Hepatitis B Surface Antigen
  • Hepatitis B Core Antibody (Total)
  • Syphilis
  • Human T-Cell Lymphotropic - Virus I/II Antibody
  • HIV-1/HCV/ HBV NAT

The final determination of donor eligibility is made by an RTI medical director – a licensed physician – using all available, relevant information.

3

The Tutoplast Tissue Sterilization Process

  • Validated chemical sterilization process
  • Thoroughly penetrates tissue
  • Inactivates or removes HIV, hepatitis, fungi and spores
  • Preserves biomechanical/biochemical integrity and native tissue structure
  • Scientifically proven and clinically successful
  • Validated by individual tissue type based on most difficult case testing using most difficult to kill organisms
  • Validated low dose gamma irradiation achieves terminal sterility of SAL 10-6



4

Removal/Inactivation of Microorganisms

The Tutoplast Process is validated to inactivate the following viruses:

  • Sindbis/Bovine Viral Diarrhea Virus (BVDV) Model
    • Human Immunodeficiency Virus (HIV)
    • Hepatitis C Virus (HCV)
    • Human T-lymphotropic Virus (HTLV)
  • Pseudorabies Virus (PrV) Model
    • Hepatitis B Virus (HBV)
    • Herpes Virus Model (PrV)
    • CMV
  • Human Poliovirus (Polio-1) Challenge
    • Hepatitis A Virus (HAV)
  • Porcine Parvovirus (PPV) Challenge
    • Parvovirus B19