Safety due to patented manufacturing process including high temperature treatment (> 1200 °C)
For the production of cerabone® a unique manufacturing process was developed including high temperature treatment at > 1200 °C. This treatment reliably removes all organic components including potential bacteria, viruses and prions [2, 3, 4, 6] and ensures maximum possible safety.
The purity of cerabone®, consisting solely of the mineral bone phase, was tested by different analytical methods  . In 2011 the high purity of cerabone® was confirmed by a leading biochemical laboratory . Final sterility of cerabone® is ensured by gamma irradiation.
Safety due to the source of the raw material
The sourcing of raw materials also contributes to the high safety of the final product. cerabone® is produced from bovine cancellous bone originating from registered abattoirs in New Zealand. According to the world organization for animal health New Zealand is a country with negligible risk for BSE .
A quality agreement with the abattoir allows the back tracing of individual animals. Additionally, a health certificate for every animal is issued by a veterinarian.
cerabone® is in compliance with the European guidelines
Both, the product cerabone® and its production process fulfill the German and EU-regulatory and security requirements for bovine bone grafts including DIN EN ISO 22442-1, DIN EN ISO 22 442-2 and DIN EN ISO 22442-3.