Automation of Formats Loading Line for GMP Freeze Dryers

This lecture addresses the issues in setting-up an automatic line to load and unload GMP freeze dryers with multiple formats under isolation technology, as well as the procedures to introduce multiple formats, cleaning, sanitisation, and line clearance. It also analyzes pros and cons of having multiple formats ready to use inside the isolator versus the introduction of formats at the time of use, in addition of risks of contamination. Is it possible to replace the manual formats by a fully automatic device that adapts to multiple formats? What are the limitations? What are the process validation implications? How production and maintenance procedures change? ROI implications, CAPEX versus OPEX.