Packaging Process Validation

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Packaging process validation is often supplemented by 100% inspection online. Many firms take the approach that a 100% online inspection is the way to go. Even today, many companies have inspectors set up offline to sort out or rework unacceptably packaged product. Often, process variables are not adequately studied or the process is not observed to “nail it” through process validation. The following approach used by a large pharmaceutical company to validate the blister packaging process may shed some insights on how Design of Experiments (DOE)—prior to packaging validation—can help.

This case study is about an OTC product. The product launch date was set in stone; the marketing managers were even talking about pre-launching the product to select large-scale retailers. The operations team was under tremendous pressure to finish the process validation and pre-launch activities of this OTC product. The product was a coated tablets, the packaging put-up was a carton with three blister cards, each card with eight tablets per card, making it a pack of 24 tablets.

The team consisted of a Packaging Engineer, an Operations Engineer, a Production Manager, a Quality Engineer and a Project Manager. Traditionally, the company validated the packaging process by optimizing the packaging process variables and making three runs. A statistically valid sampling plan would be implemented and sample packages would be tested per the finished product specifications. In most cases, this approach worked. But this was not one of those usual projects.

Let us look into the specifics. The package design required the patient to peel the foil by holding on to a center tab. See Figure 1, which shows an example of the four-way notch at the center tab. Since the product was geared towards the elderly, the package design presented some unique challenges. A trial run was performed and some samples were shown to marketing. While the overall package quality in terms of appearance and integrity was fine, Marketing thought that the package was simply too hard to open.

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Journal: 
CONTRACT PHARMA December 2004.