Enhancing Sterile Vial Filling: Improved Filling Accuracy with Transition to 1.6 mm ID Teflon Tubing in Sterile/Parenteral Manufacturing: Poster Presented at PDA Week 2026.

This project focuses on sterile processing improvements within parenteral manufacturing through the implementation of smaller diameter 1.6 mm ID Teflon tubing in a sterile filling line. The new tubing design addressed critical challenges related to yield optimization. Rigorous filling parameter cycle development testing and a novel 100% product weight verification process demonstrated the tubing's ability to maintain consistent fill weights even after experiencing off-gassing product during significant downtime events. This process enhancement led to significant improvements, including a complete reduction of out-of-tolerance fill weight alarms, a decrease in filling rejects per batch, and an increase in process capability (Cpk). This approach demonstrates how engineering innovations can enhance filling accuracy and operational efficiency in sterile manufacturing.