Cancelle™ SP DBM Sterilisation Process
DBM-based pastes and putties are sterilised through the Cancelle SP process, which is designed to preserve protein activity. Their osteoinductive (OI) potential* is verified by 100 percent lot testing after sterilisation. In their final form, the DBM implants serve as bone void fillers in many applications, including spinal, general orthopedic, joint reconstruction and dental surgeries.
Cancelle SP is a proprietary process that sterilises DBM pastes and putties while simultaneously allowing them to maintain their osteoinductive 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 and preserving the utility of the graft. The Cancelle SP irradiation dose is delivered terminally for pastes and putties to achieve device-level sterility (SAL 10-6).
* Every DBM lot induced bone formation when implanted in a modified athymic nude rat assay. Findings from an animal model are not necessarily predictive of human clinical results.