Delivering pharmaceutical elegance and physiochemical stability with lyophilisation
Complex small molecule APIs present unique formulation and stability challenges. Lyophilisation or freeze drying, a 3-stage interconnected process involving freezing, sublimation and desorption, helps deliver these agents in a form that can be easily reconstituted and administered to the patient. Sai Life Sciences has extensive experience in the development and optimisation of the lyophilisation process and ensures smooth scale-up of the product with the help of best- in-class equipment operated by highly trained personnel.
Highlights
- Successfully deployed lyophilisation in several critical projects
- Lyophilisation cycle development to help freeze dry heat-sensitive drugs to improve stability and enhance shelf life
- Developed customised freeze-drying programmes (or recipes) to match desired product specifications
- Digitally controlled system that ensures alignment with the defined lyophilisation process
- Prioritised safety by minimising exposure to the lyophilised substance with closed trays (covered by expanded PTFE on polypropylene)
- Optimised process parameters effectively in pilot studies enabling smooth scale-up
Best-in-class infrastructure
- Pilot scale
– 30L capacity, MOC: SS316L
– Condenser temperature: -85°C
– Shelf temperature: -65 to +65°C
– Maximum vacuum: 10 millitorr - Scale-up lyophilisers
– 18L and 300L capacity
– Located in class 100,000 clean rooms
– Maximum loading volume of 2L per tray for both units
– Freeze drying range -50° to 70°C
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