Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation

Background:

• A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations.
• Activity involved a scale up of freeze-drying capacity from 14 m² to 28 m².
• Additional objectives included improvements such as point-of-fill filtration and optimization of the existing lyophilization cycle.
• It was decided to robustly determine intra- and inter-batch variability and use a systematic QbD approach to comply with recent FDA guidelines.