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Gd Haze, Mallinckrodt Pharmaceuticals, St. Louis, MO, USA

Mallinckrodt Pharmaceuticals manufactures Gadoversetamide, an MRI contrast agent. Turbidity in the final product solution was investigated from several perspectives over the course of a 10-year period. In 2012, a multidisciplinary Six Sigma team was formed to determine the root cause. It was traced to an impurity in the raw material, which could be reduced by doubling the reaction time. The next 12 batches passed the turbidity specification, yielding $250,000 in annual cost avoidance.

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