A focus on freeze-drying. APS Parenteral Focus Group meeting; January 28 2015; Loughborough. UK

Smith, G. (2015) A focus on freeze-drying. Podium presentation at APS Parenteral Focus Group meeting; January 28; Burleigh Court, Loughborough, UK

Presentation Overview

1. Freeze-drying

– Process steps and questions?

2. QbD in Freeze-Drying

3. Freezing Stage

– Critical process parameters : solidification end point, eutectic formation, glass formation

– PAT in the freezing Stage (development & production)

4. Primary Drying Stage

– Critical process parameters : collapse temperature, drying rate, drying end point

– PAT in the 1ry drying Stage (development & production)

5. LyoDEA – A new PAT

– Equivalent circuit modelling

– Determination of the ice nucleation onset, the ice solidification time and the thermal equilibration time

– Impact of sucrose on mannitol crystallization

– Annealing times and the prediction of primary drying duration

– In-vial determination of the glass transition temperature, Tg'

– Strength/fragility of glass forming liquids

– Primary drying rates and end point determination

– Product collapse