Smith G. (2015) APS Parenteral Focus Group meeting; 2015 January 28; Loughborough. UK.pdf (4.64 MB)

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

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posted on 30.04.2020 by Geoff Smith
Cite as:
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

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