Methods to determine the degree of siliconisation on pharmaceutical rubber seals: advantages and disadvantages

摘要

The challenges and demands that drug packaging and packaging for drug administration devices bring are high and numerous. Rubber seals and components, in particular, have to possess specific characteristics. For instance, components for syringes and prefilled syringes, such as syringe barrels and plungers, have to be siliconised to ensure a low break-loose force and a smooth glide. A thin film of silicone oil is also important to improve the machinability and avoid clumping or deformation in bags of rubber stoppers, plungers, needle covers and tip caps. For this reason, there is a siliconisation step just before the products are packed. This step occurs at the end of the washing stage; the level of siliconisation applied depends on the final use of the products and is determined by the washing cycle, which varies with different manufacturing practices. The degree of siliconisation is adapted as a function of the type of seal. On a standard vial stopper, only a minor amount of silicone oil is required to control its non-adhesive behaviour.