Cycle Development BrochureSource: Biopharma Technology Limited
Robust and financially advantageous freeze drying cycles should be developed, for each formulation or product.
Also, these will be well positioned from a regulatory point of view, as per the FDA statement:”A manufacturer that has one cycle for multiple strengths of the same product probably has done a poor job of developing the cycle and probably has not adequately validated their process. Investigators should review the reports and
data that support the filed lyophilization cycle.”
A successful freeze drying cycle will provide reliable, safe processing in an efficient manner.
Each stage of the process – freezing, primary drying and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type of product the amount of product per batch or container, and the capabilities of the processing equipment to be used.