Optimization of the bake-on siliconization of cartridges. Part I: Optimization of the spray-on parameters

摘要

Biopharmaceutical products are increasingly commercialized as drug/device combinations to enable self administration. Siliconization of the inner syringe/cartridge glass barrel for adequate functionality is either performed at the supplier or drug product manufacturing site. Yet, siliconization processes are often insufficiently investigated. In this study, an optimized bake-on siliconization process for cartridges using a pilot-scale siliconization unit was developed. The following process parameters were investigated: spray quantity, nozzle position, spray pressure, time for pump dosing and the silicone emulsion concentration.