Case Study

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

Vial analysis

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.
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