
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
sterilization approach-cycles controlled by differential pressure-is described.
Establishing a sterilization process for liquids in containers involves trial and error, as pressure adjustments must be made during the heating, sterilization, and cooling phases. An alternate approach-cycles controlled by differential pressure-maintains the pressure in the chamber at a level that prevents the rigid containers from exploding and the non-rigid containers from becoming deformed.
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