Cancelle® SP DBM Sterilization Process

Cancelle® SP DBM Sterilization Process


The experience you need for a DBM you can trust.

RTI demineralized bone matrix is sterilized through the Cancelle® SP DBM Sterilization Process, that is designed to preserve protein activity. DBM osteoinductive (OI) potential is verified by 100% lot testing after irradiation. *In their final form, the DBM grafts serve as bone void fillers in many applications, including spine, trauma, joint reconstruction, extremities and dental surgeries.

How does the Cancelle SP DBM Sterilization Process work?

The Cancelle SP Process is a proprietary process that sterilizes DBM while simultaneously allowing it to maintain its OI potential.* Through a combination of oxidative treatments and acid or alcohol washes, debris is removed and pathogens are inactivated. Cleansing rinses remove residual chemicals, maintaining biocompatibility. Low temperature, low dose gamma irradiation preserves the utility of the graft. For most DBM-based grafts,** the irradiation dose is applied terminally to achieve SAL 10-6.

100% LOT TESTING FOR OSTEOINDUCTIVITY

Each lot of DBM processed through the Cancelle SP Process is tested for OI potential after irradiation using one of two methods.

In Vivo Testing
The American Society for Testing Materials (ASTM) has proposed a DBM quality control test based on the intramuscular implantation of DBM into athymic rats with a standardized semi-quantitative histology scoring based on the system devised by Edwards.*** RTI uses this scoring method to conduct quality control testing on each DBM lot.*

In Vitro Testing
Measurement of bone morphogenic protein (BMP) levels via Enzyme-linked ImmunoSorbent Assay (ELISA) can be used as a surrogate test marker for osteoinductive potential. ELISA is used to test for levels of BMP-2 and BMP-7.

*Performance data from studies may not be representative of performance in humans. Refer to the package insert for more information.
**Refer to product package insert for specific processing information.
***Edwards, J.T., M.H. Diegmann, and N.L. Scarborough, Osteoinduction of human demineralized bone: characterization in a rat model. Clinical Orthopaedics and Related Research, 1998(357): p. 219-28.



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 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 Cancelle® SP DBM Sterilization Process

  • Is a validated chemical sterilization process
  • Inactivates or removes bacteria,viruses, fungi and spores
  • Preserves biological integrity and natural collagen structure of bone
  • Every donor is tested for osteoinductivity* (OI)
  • Is scientifically proven

3

Sterilized Finished Implant

Inactivation of Microorganisms:

1. The Cancelle SP DBM Sterilization Process is validated to inactivate the following model, relevant and challenge viruses:

  • 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)
  • Human Poliovirus (Polio-1) Challenge
  • Porcine Parvovirus (PPV) Challenge

2. Validated low dose gamma irradiation

  • For most DBM-based products the irradiation dose is applied terminally to achieve a sterility assurance level (SAL) of 10 -6