Siliconization of vials and bottles is s special treatment adding value to your product. It provides a protective layer useful for fragile molecules, further minimizing the interactions between the product and the container (fig.1).
It prevents high viscosity infusions from sticking to the internal surface of the vials giving them a perfect transparency. Finally, due to its hydrophobic properties, the silicone coating ensures a higher restitution rate down to the last drop of product (fig.2).
Compatibility tests between the product formulation and the siliconized vials have to be performed. The resistance of the silicone coating depends on the chemical structure of the pharmaceutical product, as well as its dissolving power on silicone.
Siliconization is realized with an aqueous emulsion of a polydimethysiloxanic oil, conforming to all pharmacopeias, sprayed inside the vials. The silicone film is fixed onto glass through the annealing lehr. All vials from 5 ml to 1 liter, flint or amber, type I, II or III glass may be siliconized. To maintain the quality of the coating, siliconized vials should be stored in dry condition and at moderate temperature.
Quality control of siliconized bottles is very meticulous and is carried out throughout production by systematic sampling
For type III glass, after examining the surface of the glass a test is performed at room temperature. After uniformly moistening the bottle with a synthetic solution made up of kaolin and glycerin, the speed and uniformity of the retraction of the solution are measured.
For type I and II, an accelerated aging hot-process test is performed. The bottles are filled up to 1/5th of their capacity with a synthetic solution containing citric acid and soda. Then, the sealed bottles are heated in an autoclave set at 121°C for 30 minutes. After cooling, the quality of the retraction of the solution is observed.
Built in 1991, the siliconization unit of SGD has since undergone constant enlargement and improvement at its site in Abbeville (France) in the Verreries de la Somme ; this unit is located near the SGD plant of Mers-les-Bains.
The factory received ISO 15378 since 2007. Siliconization is achieved in a class 100,000 (ISO 8) cleanroom in activity, with the same quality control standards used during the production of the vials ; the expertise and capability of the Verreries de la Somme have brought satisfaction to the most demanding requirements.