Case Study

Helps Pharma Plant Avert Contamination

Helps Pharma Plant Avert Contamination

WIKA Patented Diaphragm Monitoring System Helps Pharma Plant Avert Contamination Several years ago, a major U.S. pharmaceutical plant suffered the loss of a full batch of an expensive drug because of contamination caused by a diaphragm seal failure. This failure of the seal on a measuring instrument allowed the diaphragm seal fill fluid to leak into the process media, leading to a shutdown of the production line, a quarantine of the product, and a time-consuming and very expensive investigation of what went wrong. This seal failure incident was serious enough to be reported to the Food and Drug Administration — a big deal as the federal agency has the authority to levy fines and even shut down a plant. It turns out that in this case, the sterile injectables being m

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