BioCleanse® Tissue Sterilization Process

BioCleanse® Tissue Sterilization Process


RTI Surgical’s allograft constructs/spacers and most sports medicine soft tissue implants are processed through its patented BioCleanse Tissue Sterilization Process, an automated, pharmaceutical-grade process. The BioCleanse Process is used on grafts that provide a natural biologic scaffold in orthopedic, spine and sports medicine procedures.

How does the BioCleanse Process work?

The BioCleanse Process sterilizes tissue to Sterility Assurance Level (SAL) 10-6 using a complex, proprietary combination of mechanical and chemical processes, working in conjunction with each other. The mechanical component applies oscillating pressure and vacuum in the presence of the chemical agents, which gently perfuse and completely penetrate the tissue. The combination of chemical agents removes blood and lipids, and inactivates or removes pathogenic microorganisms. The BioCleanse Process is validated to inactivate or remove a panel of viruses pathogenic organisms including HIV, hepatitis as well as bacteria, fungi and spores. Repeated rinses throughout the process remove debris, and final rinses remove residual chemicals, leaving the tissue biocompatible. After the BioCleanse Process, bone grafts are terminally irradiated in their packaging and labeled STERILE. Sports medicine tendons are aseptically packaged and not irradiated as studies show irradiation can compromise their integrity.1,2,3

The mechanical component applies oscillating pressure and vacuum in the presence of the chemical agents, which gently perfuse and completely penetrate the tissue.

The combination of chemical agents removes blood and lipids, and inactivates or removes pathogenic microorganisms. The BioCleanse Process is validated to remove pathogenic organisms including HIV, hepatitis as well as bacteria, fungi and spores.

Repeated water rinses throughout the process remove debris, and final water rinses remove residual chemicals, leaving the tissue biocompatible.


  1. 1 Indelicato et al. "Aseptically processed and chemically sterilized BTB allografts for anterior cruciate ligament reconstruction: a prospective randomized study." Knee Surgery Sports Traumatology Arthroscopy. 2012.
  2. 2 Schimizzi et al. "Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts." American Journal of Sports Medicine. 2007.
  3. 3 "Literature Review: Studies Investigate Tissue Processing Methods." June 2014. RTI Surgical, Inc

Pathway to Implantation

After 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 available)
  • 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 NAT-TMA

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

3

The BioCleanse® Tissue Sterilization Process

  • Thoroughly penetrates tissue
  • Preserves biomechanical and structural integrity
  • Preserves biocompatibility
  • Removes blood, lipids & marrow
  • Validated to inactivate or remove a panel of viruses pathogenic organisms including HIV, hepatitis as well as bacteria, fungi and spores.
  • Sterilizes bone and soft tissue allografts pre-packaging



4

Removal/Inactivation of Microorganisms

The BioCleanse Process is validated to inactivate the following viruses:

  • Relevant and Model Viruses
    • Human Immunodeficiency Virus (HIV)
    • HCV Model (BVDV)
    • Herpes Virus Model (PrV)
    • Hepatitis A Virus (HAV)
    • Parvovirus (PPv)
  • Spores
    • Clostridium sporogenes
    • Bacillus stearothermophilus
  • Vegetative Bacteria and Fungi - Staphylococcus aureus
    • Escherichia coli
    • Pseudomonas aeruginosa
    • Candida albicans
    • Staphylococcus epidermidis - Enterococcus
    • Enterobacter cloacae
    • Citrobacter freundii
    • Proteus vulgaris
    • Acinetobacter calcoaceticus