STANDARDS AND QUALITY
The powder manufactured by SAI responds to basic characteristics as regards composition, and also presents strong points in terms of chemical purity guaranteed by production controls.
The powder is characterized at various manufacturing stages, moreover every raw materials is systematically controlled, which enables us to guarantee the quality of the product chemical purity.
A control of the potentially introduced impurities is carried out on each batch of finished product.
An apatite of a high chemical purity is thus obtained.
The proportioned trace elements are lower than the limits fixed by ASTM F1185 for the HAP and the characteristics permitting to obtain coatings which comply with ISO 13779 and FDA requirements.
- Fe<5ppm
- Pb<5ppm
- Cd<5ppm
- AS<3ppm
- Hg<5ppm
- Ci<50ppm
The polyethylene barrel packaging makes it possible to preserve the chemical purity of the powders, contrary to the metallic containers. The powder obtained is spherical and includes a micro-porosity which can be adapted according to the needs; the dimension of micro-porosities is close to the µm.
Beyond the production, the whole company which is committed in a productive quality method certified by NF EN ISO 13485 C ertification, version 2004 and in compliance with 21 CFR 820 requirements.
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Our product quality is a responsibility shared by all the personnel. The initiatives taken and the systems used in the quality field are the subject of a permanent follow-up and improvements are constantly introduced.