When Lean Manufacturing Practices (and PAT) Save Lives

March 20, 2009

Lean manufacturing practices are designed to eliminate waste----wasted product, wasted floorspace, wasted documentation, wasted time.  Benchmarking studies by MIT several years ago showed that there were bottlenecks at many pharmaceutical manufacturing plants, especially as product awaited quality testing, and that these delays accounted for most of the processing time.  Companies undergoing Lean have often pointed out the change in mindset that accompanies such efforts ----before Lean, each department typically strives to meet its quota and maximize production, regardless of impact on the entire operation.  After Lean, they tend to think holistically.

But delays between processing steps can have a much more serious impact than lost revenues.  Last week came a cautionary tale from Hong Kong, where health authorities have traced the deaths of cancer patients, including a six-year-old child, to growth of a lethal fungus in a batch of drug that waited too long between mixing and compression/tableting, and was improperly stored in the interim.

An inexpensive handheld Raman or NIR device, or some of the rapid microbial monitoring technologies available could also have prevented this disaster.


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