For Doctors
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Supercritical Technology
14.12.01 17:37
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< Supercritical Technology >
Advanced kd-pur? Technology From very early on, KD Pharma’s manufacturing practices were specifically designed to meet stringent Active Pharmaceutical Ingredient (API) standards. It is this commitment to exceptionally high standards that has made KD Pharma the leading producer of highly purified API Omega-3 fatty acids. Our kd-pur? technology gently extracts and purifies Omega-3 fish oil in a pharmaceutical GMP certified facility. This advanced technology is capable of purifying highly sensitive Omega-3 fish oil without the use of excessive heat, chemical solvents or oxygen.
Superior Technology Simply put, we use the best technology available to produce high quality Omega-3 fatty acids. 1. Super Critical Fluid Extraction (SFE) 2. Super Critical Fluid Chromatography (SFC)11 Both steps use pressurized Carbon Dioxide (CO2) at temperatures that never go above 50°C (122°F). Under this condition, CO2 acts as an excellent solvent for Omega-3 fatty acids and can be effectively used in the extraction process. This advanced technology gently extracts and purifies Omega-3 fish oil without the use of: • Excessive heat • Chemical solvents • Oxygen
The result of kd-pur? technology is concentrated Omega-3 fish oil that has had a minimal impact on the environment. In addition to the kd-pur? process, KD Pharma has several other state-of-the art purification technologies; these include Urea Fractionation, Distillation and Nano Encapsulation. This unique technology-mix gives KD Pharma a tremendous amount of production flexibility and allows for a wide range of Omega-3 concentrates.
Urea Fractionation Urea Fractionation involves placing Omega-3 fatty acids, ethanol and synthetic urea crystals together in a vessel. The mixture is gently heated to a point where the Urea crystals dissolve. Once the Urea crystals dissolve, the mixture is then cooled again. While cooling, the Urea crystals reappear and selectively capture the saturated fatty acids. The polyunsaturated fatty acid (PUFAs) remain in solution. Once cooling is complete, the liquid is then filtered. The filter captures the urea crystals as the polyunsaturated fatty acids are drained from the vessel.
Distillation This unique process relies on the fact that solubility and volatility of an individual fatty acid depends on its molecular size. The larger the size, the less soluble and volatile they become. With the Distillation process KD Pharma can separate out various oil compositions according to their fatty acid size. Depending on a few variables, such as input quality, Distillation is capable of producing highly concentrated Omega-3 fatty acids.
Nano Encapsulation KD Pharma’s Nano encapsulation allows for the incorporation of high concentrated Omega-3 fish oil into a water soluble matrix. This unique technology allows high concentrate Omega-3 fish oil to be sprayed under pressure at the same time as the encapsulation liquid. The result is a Nano Encapsulated particle capable of being added to water soluble environments.
Quality Assurance at KD Pharma KD Pharma ensures that its Omega-3 fatty acids meet or exceed a number of strict purity parameters before they are released. Most of the analysis is performed in-house by a highly specialized and experienced team of analytical chemists and pharmacists. Some of the analysis is outsourced to internationally accredited GLP Laboratories. KD Pharma Quality Assurance uses the strictest limits available for each benchmark, whether they come from the U.S. Pharmacopoeia (USP), the European Pharmacopoeia (EP) or from KD Pharma’s own quality GMP standards. KD Pharma products are often cited as having quality limits far better than thresholds set by local and international auth |
