Manufacturing
Safety of Raw Materials
Individual cows are identified by RFID (radio frequency identification) system by wearing electronic earring markers from birth until slaughter. After slaughter, a bar code system is used throughout the distribution network so that any possible source of a disease can be tracked down. Australian cows have been certified BSE-free by leading authorities worldwide.
Safety & Efficacy of Manufacturing Process
In 2012, Chiyewon’s manufacturing facility has been certified by CE ISO13485. Ti-oss® and Octabone® have passed virus inactivation test, toxicity test, biocompatibility test, animal comparison test, gamma sterilization test, etc. done by nationally approved laboratories. Due to the state of the art low-temperature processing technique & multiporosity manufacturing technique, Ti-oss® and Octabone® show high osteoconductivity compared to the other bone graft substitute brands using high-temperature (over 1200°.)
Multiporosity Manufacturing Technique
The most important factor in the healing process of bone graft is the relocation of blood vessels into the graft to supply the necessary oxygen, nutrients, and cells. This a the critical factor during the first two weeks of bone growth (Reference: Clinical Data- Bone Graft Biology). Multiporous characteristics provide this essential environment. Multiporosity is found in cancellous bone and not in cortical bone. For over 2 years of in-depth experimentation, Chiyewon has developed a unique & simplified technique in making 0.5-1.2mm & 1.2-1.7mm size of a cancellous bone substitute.
Octacalcium Phosphate Crystal
Unique to Chiyewon, the advanced octacalcium phosphate crystal material adds to the osteopromoting factors resulting in better and faster bone formation.