European EC Certified, MFDS Approved.Lorient shows a low and consistent injection force of a mere 7~8N (measured with 27G needles). This allows for a smooth and effortless filler injection, which reduces tissue damage and improves the safety of procedures.
Injection force over 0–25 mm of extrusion. Lorient stays flat at about 8 N after roughly 2.5 mm, while Products X, Y and Z fluctuate between about 10 and 37 N.
Lorient is manufactured in the production line designed for pharmaceutical injectables. Complying with GMP standards not only for medical devices but also for pharmaceuticals, we reduced impurities in our fillers significantly with the use of clean rooms and building-wide HVAC equipment.
Lorient shows an osmotic pressure of 300 mOsm/kg, which is very similar to the osmotic pressure of human blood. This allows for the human body to feel Lorient to be less of foreign body after injection. Our in-house test data shows that Lorient's osmotic pressure is closer to blood in the body in comparison to other dermal fillers.
Residual crosslinking agent (BDDE) and endotoxin are rigorously controlled since they might cause inflammatory reactions. Unreacted BDDE at 2 ppm or lower, and endotoxin from the fermented hyaluronic acid below 20 EU per syringe: these are the limits set out in a review of what causes delayed inflammatory reactions.1 Our in-house standards sit well below them, and when measured, neither impurity reached the detection limit of the instrument. An ideal filler should be as pure as possible, the paper concludes. We keep that promise in numbers.
| Category | Result | Published limit | Company standard |
|---|---|---|---|
| Residual BDDEUnreacted cross-linker | Not detectedBelow the detection limit | 2 ppm or lower1,2 U.S. FDA recommendation | 0.5 ppm or lower |
| EndotoxinFrom fermented hyaluronic acid | Not detectedBelow the detection limit | Below 20 EU per syringe1 | Below 0.5 EU/mL |
References
Lorient with lidocaine was approved for sales in Europe.Lorient without lidocaine was approved for sales in Europe.
