Dermalstyle® Products are manufactured in compliance with ISO 9001, ISO 13485 and GMP (Good Manufacturing Practice) standards as well as the European Council Directive (93/42/EEC) concerning medical devices.
Toxicology and biocompatibility trials have been performed in compliance with the guideline ISO 10993.
Therapeutic safety is our top priority. The ingredients used forDermalstyle® guarantee 100% safety. Thanks to the innovative technology, the Dermalstyle® line meets the highest quality standards and is absolutely safe.
The Dermalstyle® range belongs to the safest dermal fillers on the market, due to the extremely low level of crosslinking agent BDDE. Furthermore, we continually monitor the manufacturing process to ensure the highest product quality.
We only use a natural hyaluronic acid for synthesis, and all our products are twice sterilized. That’s why you can be absolutely sure that the procedure is absolutely safe.
Only pure and natural acid of non-animal source is used for synthesis in a multistage process using the well-established BDDE (butanediol-diglycidyl-ether) as reticulating agent. It creates a stable and very dense three-dimensional hyaluronic acid network.
Viscoelastic optimization ensures obtainment of a smooth, highly viscous monophasic gel, showing the highest level of elasticity. The Dermalstyle® gel is perfectly homogeneous because of the innovative and modern technology of the homogenization process.
An elaborate and continuous purification process removes all undesired compounds from the gel. The technological process is completed by the removal of oxygen from the gel to ensure the stability of the gel once it is filled into a syringe.
The purification process ensures that crosslinking agent residuals are kept below the lowest detectability level (<1 ppm).
|EU Standards||Dermalstyle® Light||Dermalstyle® Regular||Dermalstyle® Forte||Dermalstyle® Smile|
|BDDE||< 2 ppm||NA||< 1 ppm||< 1 ppm||< 1 ppm|
|Endotoxins||< 0,5 EU/ml||< 0,5 EU/ml||< 0,5 EU/ml||< 0,5 EU/ml||< 0,5 EU/ml|
|pH||6,8 - 7,6||7,0||7,0||7,1||7,0|
|Osmolarity (mosm/kg)||200 - 400||300||300||291||300|
|Proteins||< 1000 ppm||14 ppm||11 ppm||8.7 ppm||9.2 ppm|
We guarantee quality and safety by
- carrying out controls during the whole manufacturing process to ensure our products comply with all quality standards;
- 100% visual inspection of all syringes to guarantee absolute purity and absence of particles for the security of the persons treated;
- terminally sterilizing our products in a steam autoclave once the gel is filled in the syringes. This process ensures a higher safety than the aseptic filling of the syringes (sterility assurance level of 1 in 1.000.000 vs. 1 in 1.000).
Dermalstyle® the revolutionary range of high-quality products, based on hyaluronic acid and invented for overall anti-aging care treatment. By using Dermalstyle® products for filling-wrinkles and mesotherapy procedures you have a guarantee for natural look and immediate visible effect.
Furthermore Dermalstyle® treatments are highly efficient, safe and well-tolerated.