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—is important with its own challenges and requirements. Many other factors will also directly affect the cycle, including the specific characteristics of the product, the amount of product per batch or per container, and capabilities of the production equipment to be used.
BTL designs cycles on a rational basis founded on in-depth analysis of the formulation. Once essential thermal characteristics of the product are understood, an initial cycle can be drafted and tested. Our pilot-scale freeze dryers are equipped with sophisticated monitoring and data trending capabilities to return information about the progression of the product throughout the trial freeze drying runs.
Freeze drying cycles are optimized with reference to a specific product and freeze dryer: each cycle is unique. Changes in formulation, container or equipment will affect the manner in which the product is processed. Using techniques similar to Cycle Design, existing cycles can be analysed to ensure that they are not overly conservative. Additional processing steps such as annealing can also be recommended in instances where they will provide benefits in terms of process duration, product quality or cycle robustness.
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