Join BD at
Pharmapack 2024
- the heart of
Pharma

DAY 1 Jan 24 - 15:10 - 15:40 CET.

Including 5-minute Q&A

Oxygen permeability considerations and performance for prefillable syringes

Guillaume Lehée, Product Engineer at BD Medical - Pharmaceutical Systems

Numerous drug technologies are advancing into pre-clinical and early clinical phases to enable new therapies with improved health outcomes. Those new technologies carry potential challenges pertaining to their compatibility with the container materials and with environmental conditions such as temperature or exposure to gases. One historically common degradation pathway of pharmaceuticals is oxidation.¹

Therefore, there is a need to monitor and quantify the oxygen ingress within prefillable syringes to derisk pharma combination product development. This study, conducted on several prefillable syringe configurations, will highlight the influence of components on oxygen permeation and measure the syringe protection performance against oxygen ingress at different storage temperatures.

DAY 1 Jan 24 - 14:30 - 15:10 CET

Rooms 725 and 726

Transforming pharma fill/finish processes with RFID² -enabled prefillable syringes: use cases and live demo

Yacine Haddadi, Senior Global Marketing Manager at BD Medical - Pharmaceutical Systems. Jenni Krohn, Market Development Manager at Avery Dennison Smartrac

This presentation explores an innovative solution to address challenges in pharma Fill/Finish processes: Container-level traceability (CUID). This pioneering approach utilizes RFID (Radio Frequency Identification) to ensure accountability for each container in the fill-finish processes, down to the individual unit.

In the short term, CUID can mitigate exposure to mix-up, improve OEE through automated reconciliation, and cut waste with unit-by-unit segregation. Beyond this, CUID has the potential to eliminate data silos and bridge the gap between each manufacturing process step. Manufacturers can harness advanced data analytics to unveil hidden patterns, identify process inefficiencies, and detect trends and anomalies that were previously unnoticed.

In collaboration with Avery Dennison Smartrac, a leading provider of RFID inlay solutions, BD has conducted a proof of concept and will demonstrate the feasibility of the solution through a video of the BD RFID Demonstration Lab and a live demo.

Combination product development requires biocompatibility testing, as per ISO 10993-1 (2018) guidelines, which can represent a significant portion of development timelines. This presentation outlines the approach BD Medical - Pharmaceutical Systems takes when designing and implementing biocompatibility testing to meet ISO 10993-1 (2018) and regulatory requirements for combination products.

Based on combination product categorization, this will include biological evaluation using in vitro and in vivo techniques, and chemical analyses to detect potential extractables. In addition, Materials of Concern declared by suppliers, as well as extractables that are detected analytically, are subjected to toxicological risk assessment as a means to de-risk the combination product.

The speaker will also highlight how biocompatibility testing can help de-risk combination product development timelines for combination products by leveraging BD Medical - Pharmaceutical Systems internally generated statistics from previous regulatory body requests and resolution timelines, when supporting pharmaceutical partners’ regulatory submissions.