Damaged Goods - Whose Responsibility?

By Robert McGregor

Tablets and capsules that fall apart prematurely is a problem that we have all experienced as consumers. Who is responsible for the failed product? Should Quality Control receive production batches from manufacturing and be able to detect potential failures before they reach the customer? What tools does R&D provide to QC for identifying potentially weak capsules and tablets?

Texture Analyzers are instruments that measure materials using compression or tension and are becoming popular for use in measuring the durability of tablets and capsules. Figure 1 shows a Texture Analyzer with a cylinder probe that is pushing downward on a jar of gelatin. This standard procedure is called the Bloom Test and has a prescribed protocol for type of probe (cylinder with defined cross-sectional area), speed of probe downward movement (0.5mm/sec), and depth of penetration (4mm). The test determines the firmness of the gelatin and is ultimately used to value each batch of gelatin for its commercial worth. Manufacturers of gelatin capsules use this procedure to confirm that the gelatin has the desired strength rating they need for producing their capsules.