Date: March 18 - 19, 2019
Location: Bethesda North Marriott Hotel & Conference Center - Bethesda, Maryland
The 2019 ISPE Aseptic Conference, now in its 28th year, focuses on the future of aseptic processing, including containment, multi-product facilities, and the increasing use of robotics.
Date: March 19, 2019
Time: 11:35am - 12:00pm
Title: Technical and Component Considerations for Achieving High Dose Accuracy
Catalent Presenters: Alex Haig, Senior Director, Engineering and Marc Engel, Senior Process Engineer
Abstract: The auto-injection device market is driving higher accuracy and tighter filling specifications for dose accuracy. Catalent Biologics has been working with clients to optimize fill accuracy for high value and personalized medicine, and has studied how controllable variables such as machine capabilities, process parameters, and dosing path configurations can be optimized to compensate for the uncontrollable challenges caused by product characteristics and component specifications. In this presentation, we will share case studies of how we optimized the filling process for unique product characteristics, such as viscosity or crystallization. We will review our specialized product development approach to 6-sigma filling, and share challenges and lessons-learned from the Catalent Biologics facility in Bloomington, Indiana.