Product Testing and Processing
Product Testing and Processing
Material Information
Regenafil® and Regenform® Allograft Paste Products are single donor allograft products that offer optimum DBM concentration to maximize new bone formation.
Tissue Processing
Regenafil and Regenaform are processed by RTI Biologics (RTI) and distributed by Exactech. RTI’s innovations continuously raise the bar of science and safety for biologics: RTI was the first company to offer grafts designed to maximize each gift of donation and invent fully validated sterilization processes that include viral inactivation steps.
As a tissue processor and medical device manufacturer, RTI maintains a Quality Management System in compliance with the following federal and state licensure/regulations and voluntary standards:
• FDA Current Good Tissue Practices, 21 CFR Part 1271
• FDA Current Good Manufacturing Practices, 21 CFR Part 820
• State of Florida Statutes (other state licenses as applicable)
• AATB Standards for Tissue Banking
• ISO 13485, Medical Devices Quality Management Systems
RTI is registered with the U.S. Food and Drug Administration (FDA), which conducts periodic inspections. Quality inspections are also performed by applicable state regulatory agencies, as well as accreditation and certification organizations, such as the American Association of Tissue Banks (AATB) and Notified Bodies for ISO certification.
RTI’s Biomedical Laboratory holds the following registrations, certifications or licenses:
• FDA Registration
• CLIA Certificate of Compliance (Federal)
• State of Florida (other state licenses as applicable)
Sterilization
RTI-processed bone pastes are sterilized through the demineralization process. This process has been validated to achieve viral inactivation, and combined with terminal sterilization, allows RTI to provide sterile DBM paste products.
“The demineralization process inactivated infectious retrovirus in infected cortical bone, thereby preventing disease transmission.”
- Journal of Bone and Joint Surgery (February 2003)
The demineralization process is validated to inactivate relevant and model viruses:
• Human Immunodeficiency Virus (HIV)
• HCV Model (BVDV)
• Parvovirus (PPV)
• Herpes Virus Model (PrV)
Final safety assurance step:
Following processing, RTI bone pastes undergo low-temperature, low-dose gamma sterilization before final release. Grafts sterilized in the final package are validated to achieve10-6 sterility level.Resources
*All references to "validated" sterilization processes indicate that the validation meets or exceeds requirements for product sterilization, i.e. a SAL of 10-6 per AAMI and ISO Standards.
