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
After the BioCleanse Process, sports medicine tendons and meniscus are aseptically packaged in an ISO certified class 5 cleanroom and not irradiated as studies show irradiation can compromise their integrity.1,2,3 This aseptic packaging episode allows for a thorough inspection because blood and lipids are removed from tissue inside the BioCleanse processing chamber, making it is easier for processors to identify issues such as fiber separation and tendinopathy. RTI meticulously cultures all tissue, working surfaces and instruments involved to verify the absence of contamination. In the event of a positive culture result, all associated tissue is destroyed. Only tissues that meet RTI’s strict acceptance criteria are released for implantation.
After the BioCleanse Process, bone grafts are terminally irradiated in their packaging and labeled STERILE.
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 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 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 "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.
- Donor risk assessment
- Medical / hospital record interview
- Medical examiner/coroner’s report (when provided)
- Laboratory, pathology & radiology reports (when available)
Infectious Disease Testing
- HIV-1/HIV-2 Antibody
- Hepatitis C Virus Antibody
- Hepatitis B Surface Antigen
- Hepatitis B Core Antibody (Total)
- 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.
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 and pathogenic organisms including HIV, hepatitis as well as bacteria, fungi and spores.
- Sterilizes bone and soft tissue allografts pre-packaging
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)
- 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