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Graphic with ice crystals and vialGraphic with ice crystals and vial
On the right track from the start

Design of drying processes with the design space

The time-to-market is a crucial factor in pharmaceutical production. Pharmaceuticals should reach the patient from the laboratory as fast as possible. Early detection of potential risks minimizes unnecessary costs in the production phase.

If the product is to be freeze-dried, it is therefore critical to understand the features of every freeze-dryer thoroughly. This means it is possible to derive a concept for the pilot plant or production facility in the pre-clinical stage of the product. A central element is thus the so-called design space, which outlines the behavior of the system process in a specified area.

Scaling from laboratory system via pilot system to production system
Determining the design space
Ideal freeze-drying process with high tech

The critical process and material attributes for the quality are correlated in the design space. This produces a threshold where the quality of medicinal products is not exposed to any extreme fluctuations and is controllable. By specifying a design space, the conditions for a sustainable quality of the product are defined in advance.

A threshold is the critical product temperature that is required before a collapse occurs.  The second limit is the efficiency of the plant. The course of the chamber pressure and the sublimation rate is dependent on the heat transfer coefficient of the vial and the product resistance, which determines the correlation between the controlled parameters and the product temperature. Changes in the construction or the function of the freeze-dryer as well as product deviations can alter the properties of the freeze-drying cycle and lead to product failures. The sublimation requires a constant and homogeneous heat, which is regulated by the shelf temperature. Irregularities in the plate temperature can result in uncontrolled freeze-drying.

Figure of sublimation rate vs. chamber pressure

The design space enables you to take into account tolerances in raw materials, the product preparation and the vials in the design of the drying process. This way you achieve a consistently high product quality from the outset.

OPTIMA pharma | Experts for lyophilization
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OPTIMA pharma | Experts for lyophilization
OPTIMA pharma | Experts for lyophilization
OPTIMA pharma | Experts for lyophilization
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