Proof of Processability for New Coated Stopper on Filling and Assembly Lines. A Collaborative Study by Bausch+Ströbel and BD Medical – Pharmaceutical Systems

In this webinar, originally broadcast as a part of Pharmapack Europe, Eve-Marie Vaccaro, Global Sales & Operation Planner, and Edgar Bauer, Global Key Account Manager Bausch+Ströbel from BD Medical - Pharmaceutical Systems discuss how VHP sterilization is a viable alternative for ensuring improved patient safety by providing a sterile product application for drug delivery devices, such as pre-filled syringes with temperature or radiation sensitive drug products, that are too sensitive for conventional methods of sterilization. Material selections, device design, properties of the pre-filled syringe, and secondary packaging decisions (shape, materials) play an important role in ensuring the sterilization process is successful. The major things to avoid are known in the industry, but there are more opportunities for proactively preparing for this in advance, during the design phase, when making considerations for the intended sterilization method - for example - thinking about applying the IPCD (internal process challenge device and EPCD (external process challenge device) in good time beforehand. These are key considerations when aiming at short lead-time product-to-market strategy - from sterilization perspective. This presentation looks at these from this viewpoint.