GSS HIGH PRESSURE HOMOGENIZER is capable of giving the highest effeciency in the manufacturing of PROPFOL.

In GSS homogenizer, the propofol emulsion smallest mean Droplet size 220 nm is achieved. since, 220 nm globule size is much smaller than human smallest capillary (5-7 micron) therefore, there is no risk for capillary blockage and embolism.

•  An emulsion is usually comprised of two or more immiscible liquids where one liquid in the form of  droplets is dispersed (the dispersed phase) in another liquid (the continuous phase) .
  The surface of each droplet is an interface between hydrophilic and hydrophobic molecules Emulsion is thermodynamically unstable. The stability of an emulsion can also be affected by many external factors including storage methods (glass vs. plastic), time, and temperature.

• Injectable Propofol emulsion is Nano Emulsion 99% particles are in nano meter size range (1 nano meter-500 nano meter). Some Particles are micron range Those bigger particles are produced due to high pressure homogenization inefficiency, emulsion instability or various other factors According to the USP 729, particles bigger than 5 micron should be less than 0.05% So the boundary is size >5 micron amount <0.05% which is called PFAT5. Conventional Emulsion: 1-20 µm Nano/Micro Emulsion: 10-200 nm.

•  Propofol (2,6-diisopropylphenol) is a potent lipophilic anesthetic that is an oil-in- water or lipid-based emulsion.

• Histology: Oil-Red-O staining of fat Stable Infusion Unstable Infusion DFD-HMS-06

• Method 1 – Dynamic or Static Light Scattering ? Mean Droplet Size (MDS), expressed as the intensity-weighted MDS, and must be < 500 nm.

• Method II – Light Extinction employing Single- Particle Optical Sensing ? Large-Diameter Tail, expressed as the volume- weighted percentage of fat > 5 micrometers or PFAT > 5 µm or PFAT5 , and must be < 0.05%.

• The minimum diameter of human blood capillary is 5-7 micron. If the injectable emulsion has fat globules/particles larger than 5 micron it will block the blood capillary. The normal blood flow will be stopped. Thus blood vessel embolism may cause death to a patient.

Disclaimer:- Above details and picture for understand purpose only.