Process performance qualification (PPQ) runs are essential for ‘at-scale’ verification of the robustness of R&D lyo-processes, as these runs can often unravel challenges not encountered at the R&D scale. This case study exhibits the loss of pressure control in a commercial lyophilizer during PPQ runs of a parenteral product, its root cause analysis and finally, its resolution via remote PID-tuning performed by IMA Lab4Life scientists.
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