Microanalysis of packaging ink points to problem in manufacturing process
Mary Stellmack
Healthcare Packaging - April 23, 2012

Pharmaceutical packaging is designed to keep the product free from damage and contamination; however, occasionally the packaging itself is the source of product contamination. A pharmaceutical company noticed a problem with several white tablets that displayed small blue defects at random locations on all faces of the tablets. The defects were less than 0.1mm in size, as shown in the photograph here.

When the tablets were cross-sectioned with a razor blade, it was found that the defects were limited to the outer surface of the tablets, and consisted of very thin flakes of a blue substance. The pharmaceutical firm suspected that the defects were fiber fragments from blue cloth wipes or blue hairnets that were used in the process areas of the manufacturing plant. While working in a cleanroom under a stereomicroscope, McCrone removed some of the blue flakes from the tablets by hand by with the aid of fine tungsten needles.

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