A pharmaceutical client was at risk of a product recall due to a capping problem with a new tablet formulation. Visual inspection at the packaging had identified that capped/laminated tablets had made it through to the packaging stage despite the tablets having met intermediate quality inspection.
Since capped/laminated tablets are unlikely to meet the correct dosage requirements for the API, the entire batch of the product would be rejected or a product recall would be possible if the product did get into circulation. The challenge faced by the client was how to accurately and cost effectively measure the thickness and integrity of the tablet prior to packaging.
The original manual inspection had not been able to consistently identify the hairline cracks and, during shipment of the tablets, some tablets separated leading to the loss of small portions of the tablet, affecting the ultimate dosage of the API. While some minor defects were allowed, these capping issues of a “critical” nature put the client at risk of a product recall.