Dermal Fillers and Volumizing Fillers
IGA Point Ltd's., fillers and volumizing fillers are produced in line with Dynamic Double Cross linked Optimization Technology (DDCI-OT technology).
Dermal Fillers Manufacturing Technology
Based on stabilized hyaluronic acid (HA), the gel has total biological compatibility, it is viscoelastic, sterile, apyrogenic, predictable, clear and colorless; its biodegradation does not affect tissue architectonics.
As the reticulating agent in HB fill preparations, the tested 1,4-butanediyl diglycidyl ether (BDDE) is used which creates irreversible carbon bridges between hyaluronic acid molecules, which as a result increases the drug resistance.
Stabilized Hyaluronic Acid
1, 4-butanediol diglycidyl ether
Crosslinking transforms the linear chains of hyaluronic acid into a three-dimensional structure that is more resistant to enzymatic degradation, while maintaining its biocompatibility.
The crosslink density directly affects this ability to absorb water. With a greater amount of crosslinks, the chains of hyaluronic acid will be closer and less flexible, making the connection with water more difficult.
The manner in which crosslinking is performed during the manufacturing process leads to the dermal fillers’ characterization as biphasic combined with monophasic poly-densified hyaluronic acid based fillers.
Monophasic poly-densified hyaluronic acid
In biphasic products, the crosslinked hyaluronic acid is sieved through a screen to isolate crosslinked HA particles of uniform size. On the other hand, monophasic fillers are not sieved and contain a mixture of randomly sized and shaped pieces. Monophasic poly-densified fillers add additional hyaluronic acid and further cross-linking after the initial mix.
Dermal fillers properties create a gel with different zones of densities, permitting optimal spreading throughout the tissue whereas conventional HA fillers would not be able to fill the smallest gaps.
Monophasic poly-densified fillers
The elastic component, represented as G’, is another important physical property. It reflects the ability of a gel to resist deformation when a force is applied against it. A gel with a greater elastic component will be firmer and stronger and will undergo fewer changes in shape when pressure is applied to it.
Elastic component G
IGA Point Ltd.’s dermal fillers in the concentrations of 18 mg/ml, 23 mg/ml and 26 mg/ml will have a greater ability to generate volume and support. Additionally, it has an increased ability to withstand the daily dynamic forces such as movements of facial muscles; therefore, it is more suitable for areas such as the nasolabial and nasogenian grooves. A more fluid gel in an area that suffers high pressure would not resist deformation and would be pushed towards the area of lowest resistance, resulting in worse clinical results and lower procedure durability.
Volume Support Durability
HB FILL Technology
Quality Regulation Compliance
Dr. Korman Laboratories Ltd activities are conducted under a certified quality system according to ISO 9001:2008, ISO13485:2003 and EN/ISO 13485:2012.
Dr. Korman Laboratories Ltd.’s production premises are designed, built, maintained and qualified through periodic environmental monitoring and validations of the clean rooms, thus complying with the EU cGMP requirements for Class 5 clean rooms.
All production and distribution records allow backward and forward traceability of the products.
HB fill products are medical devices classified as Class III according to 93/42/EEC Directive.
A state of the art European manufacturer of Pharmaceutical/Medical Grade.
(European Monograph N ° 1472) provides the raw material of the Hyaluronic Acid products; this guarantees the highest quality of Hyaluronic Acid products.
The Sodium Hyaluronate is provided with a molecular weight of 3000 kD.