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Tuesday, October 5th
Session 2, Track B
Enrico Barichello - Product Manager
Pre-fillable syringes available on the market, and several associated components, are not always suitable for aggressive biopharmaceuticals. The performance of the silicone oil, which is used as a lubricant to ensure smooth plunger action with lower injection force, can be compromised by the nature of the drug. Parenteral formulations could affect the syringe’s gliding properties, leading to an incomplete injection when using auto-injectors and, in some cases, may lead to product recalls. In addition, silicone migration from the syringe body and/or components may also generate sub-visible particles that might compromise product safety and efficacy. To address these issues, Stevanato Group conducted a study comparing the performance of new inert coating technology to an optimized silicone oil technology, both in the same syringe configuration and conditions over time. To increase the reliability of drug delivery, this presentation will illustrate the above-mentioned study results and a systematic understanding of the layer stability of the syringes filled with different pharmaceutical placebo solutions. Results show an improved behavior of the novel coating from a mechanical, morphological, and particle count standpoint, highlighting how solutions can increase risks associated with silicone if not considered from the early phase of the primary container selection.