Cerasorb^® quality assurance

Cerasorb^® is manufactured in a dedicated plant in Frankfurt, Germany. Cerasorb^® is produced under clean-room conditions in a validated, computer-controlled, high-temperature sintering process out of the raw materials calcium carbonate and calcium hydrogen phosphate. Incoming goods inspections of both the synthetic raw materials and the packaging materials are carried out according to the most stringent quality assurance requirements.

The synthesis of Cerasorb^® is accompanied by extensive internal and external chemical and mineralogical analyses. The geometries of the different block forms are produced on a computer controlled, high-speed CNC machine. The curasan proprietary manufacturing process allows the production of highly regular stable material with a pre-defined porosity and granule size. The high temperature sintering process eliminates potential bacteria as well as potential pyrogens or other impurities. The production process of Cerasorb^® guarantees a mineralogical phase purity of more than 99% β-tricalcium phosphate. For this reason Cerasorb^® is the worldwide standard for β-tricalcium phosphate. The product is packaged under controlled, clean-room conditions and then subjected to a validated gamma irradiation procedure.

Cerasorb^® has an excellent safety profile and has never been recalled and never been issued a warning. Cerasorb^® complies fully with all applicable FDA and CE regulations.