Bechtold-Peters, Karoline, Moll, Fabian and Friess, Wolfgang (2023) Evaluation of a novel silicone oil free primary packaging system with PTFE-based barrier stopper for biologics. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 190. pp. 206-219. ISSN 1873-3441

Abstract

In order to overcome silicone oil related problems for biopharmaceuticals, novel container systems are of interest with a focus on the reduction, fixation or complete avoidance of silicone oil in the primary container. Ultimately, silicone oil free (SOF) container systems made from cyclic olefin (co-)polymer or glass combined with the respective silicone-oil free plungers were developed. In the following study we evaluated the potential of a SOF container system based on a glass barrel in combination with a fluoropolymer coated syringe plunger. In a long-term stability study, the system was compared to other alternative container systems in terms of functionality and particle formation when filled with placebo buffers. The system proved to be a valuable alternative to marketed siliconized container systems with acceptable and consistent break-loose gliding forces and it was clearly superior in terms of particle formation over storage time. Additionally, we evaluated the importance of the glass barrel surface for functionality. The interaction of the fill medium with the glass surface significantly impacted friction forces. Consequently, storage conditions and production processes like washing and sterilization, which can easily alter the surface properties, should be carefully evaluated, and controlled. The novel combination of non-lubricated glass barrel and fluoropolymer coated plunger provides a highly valuable SOF packaging alternative for biopharmaceuticals.

Item Type:	Article
Keywords:	Silicone Oils Biological Products Fluorocarbon Polymers Drug Packaging Syringes Polytetrafluoroethylene
Date Deposited:	07 Oct 2023 00:45
Last Modified:	07 Oct 2023 00:46
URI:	https://oak.novartis.com/id/eprint/46575