pharmind: Silicone Oil Induced Effects in Pharmaceutical Glass Vials

Pharmaceutical fillers experience a variety of nuisance problems when packaging formulations into containers such as syringes, cartridges, and vials. For liquid biological or freeze-dried drug formulations, the presence of deliberately applied or adventitiously migrating silicone oil can lead to undesired effects such as beading, spotting, abnormal menisci,particulate formation, aggregation, and adsorption. Determining the root cause for these issues is often challenging asfor each of the aforementioned effects there are numerous potential root causes, many of which are not necessarily linked to the presence/absence of silicone. There is a need inthe pharmaceutical industry for a straightforward, compact, and robust study protocol for determining if the observed container/solution issues are due to presence/absence/amount of silicone oil. The authors provide data from pharmaceutical glass vials addressing potential silicone migration and cross-contamination based on qualitative and quantitative characterisation methods. The combination of different methods (wetting testing, ToF-SIMS and GF-AAS) is a powerful tool for a reliable assessment. The simulating test results confirm that a cross-contamination of glass vials through a pharmaceutical washing process and migration of silicone from a preceding processing of baked-on silicone vials is unlikely.