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Critical process parameters for Lyophilized Product Development:
– Freezing temperature
– Primary drying temperature
– Secondary drying temperature
– Time for annealing
– Pressure and timeShelf temperature and chamber pressure are to be considered as critical process parameters for lyophilization.
@FRD
Liquid nitrogen is one of the safest cooling agents for pharmaceutical use. It can ensure extremely low temperature, which is required for freeze drying in lyophilization process.Liquid nitrogen also offer a wider processing window to added flexibility and productivity benefits.
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