Vials and ampoules are sometimes pre-siliconized by the manufacturer or siliconized just after the washing process. Siliconized vials are used in freeze-dried products, vaccines or formulations requiring a protected glass wall. One advantage of vial siliconization is that less overfill is needed to administer the product.
It is imperative that one prevents and eliminates holes in the Silicone Oil Layer because otherwise there is no layer of protection separating the glass from the formulation. In other words, process parameters are necessary for optimization and optimization is necessary for steady quality products. Each step in the process including: cleaning, drying, spraying, filling, baking time, and temperature influence the end result.
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It takes the LE UT just minutes to provide highly accurate and repeatable silicone layer thickness distribution data about a single cartridge. Therefore, the emulsion siliconization process can be validated, controlled, streamlined as well as implemented.
The following steps provide an ultra thin layer of silicone. First, spray an emulsion of silicone oil and water into a glass cylinder. Second, put the mixture into the oven for several minutes at approx. 300 degrees Celsius. The resulting baked-on silicone oil layer is usually very homogenous with a minimal amount of silicone.
Once the emulsion siliconization process is in place, it produces stable and repeatable products in bulk. However, the process is influenced by many variables, and therefore requires an experienced operator. The LE UT is intended to optimize, streamline, validate, and enable reliable decisions based on scientific results in emulsion siliconization processes.
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