Uniform handling. Proven operation.
Proven, integral and validated six-step system that combines examination, evaluation and mechanical, chemical and radiation processes.
Step 1: Control the bioburden
- Rigorous and meticulous donor examination process: less than 2% of all potential donors are accepted.
- Complete physical examination of the donor.
- Rigorous retrieval protocols.
Step 2: Evaluation of the bioburden
- All samples recovered from tissues are tested for microbiological contamination.
- Standard microbiological methods utilizing aerobic and anaerobic media to culture and identify bacteria and fungi are used.
Evaluation of serological contamination
- All blood samples are evaluated for hemodilution.
- Laboratories must be certified by the CLIA to perform donor examination tests.
- Test kits must be licensed by the FDA and approved for cadaver testing.
- The nucleic acid test reduces the “time window” of infectivity.
Step 3: Pollution containment
- Allografts are processed in state-of-the-art GMP / ISO class 7 rooms or in cleaner rooms.
- The processing environment is subjected to validated environmental monitoring on a daily, weekly and monthly basis.
- The centers maintain a level of neatness that minimizes or eliminates the pollution induced by the environment.
Step 4: Cleaning regime
- A dry, wet centrifugation sequence designed to expel blood, fat and lipid components from the allograft matrix.
- Application of patented “Allowash” solution under ultrasonic conditions, designed to remove bacteria and viruses.
Step 5: Disinfection regime
- It uses a patented step that includes ultrasound, specific temperatures and chemicals to eliminate bacteria and viruses.
- Followed by several steps of soaking and rinsing, as well as microabsorption to remove possible residual reagents.
Step 6: Complete Sterilization
- Controlled conditions including cold temperature.
- A validated dose mapping configuration.
- A dose that depends on the allograft.
Features and Benefits of Optium DBM Gel:
- Potentially Osteoinductive
- Previous Osteoinductive Tests
- Approved Donors
- Ready to use
- Multiple size options