Reducing End-of-Line Rejects
Few topics generate as much interest as the reduction of drug manufacturing end-of-line rejects, which is one of the clearest and easiest ways to reduce waste and maximize operating profit and may help improve patient safety. One of the largest contributing factors to the end-of-line reject rate is the quality of the packaging components selected for the drug product.
The manufacturing process for packaging components is not perfect, and pharmaceutical manufacturers understand that there will be a small number of defects and embedded and loose particles in each component lot. Typically, these defects fall well within the component manufacturers’ acceptable quality level (AQL) specification, but industry requirements may be tighter.
Incoming inspection processes, while necessary, will not reduce end-of-line rejects. Incoming inspection merely confirms the component manufacturing process produced its intended product with its intended specification, but it obviously does not change the component manufacturing process. Even 100 percent vision inspection is not a complete solution because quality cannot be inspected into a component.
True end-of-line reject reduction comes from a well-understood component manufacturing process that sets control strategies around critical process parameters, monitoring processes and trending data to ensure components are manufactured within a control space. This builds quality into the manufacturing process and ultimately reduces defects and particulate, providing a tighter specification that can be directly translated into reduced filled drug product rejects.
West has developed the NovaPure® stopper and plunger product line around these principles, providing a tighter particulate specification – including subvisible particulate, dimensional CpK data, and a tighter defect specification provided in both AQL and PPM, which directly translates to the end of the drug product filling line. When a filled drug product reject can cost hundreds of dollars, improved component quality can make a marked difference in operating profit.