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Return Of Ductwork Cross-Contamination In Plants Flagged By US FDA Experts

 
• By Bowman Cox

Cleaning oversights are again allowing drug residues to collect in manufacturing equipment ductwork and contaminate drug product batches at sometimes dangerous levels, agency enforcement and compliance officials say. They share some ideas for getting such problems under control.

Fluid bed dryer
time to plumb the ducts again • Source: Alamy

It's an old issue that appears to have made a comeback, according to Francis Godwin, director of the Office of Manufacturing Quality, a part of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

It came up in 2012 when the agency inspected a US-based generic drug manufacturer after receiving some concerning field alert reports, Godwin told last year’s virtual Parenteral Drug Association/FDA conference.

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