Pharmaceutical Packaging

Criteria for Choosing the Right Inspection System for Pharmaceutical Packagings

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But these systems provide additional benefits beyond superior product quality. Compared to manual inspection, bulk optical inspection systems reduce labour costs, often replacing 10 to 15 manual inspectors, and increase yield. Compared to diverging roller sorters and single-file optical systems, bulk optical inspection systems speed changeovers.

And these systems reduce capital costs and simplify operations compared to singlefile optical inspection systems. However, there are less obvious benefits that can be achieved with bulk optical inspection systems – those associated with replacing batch processes with continuous, integrated automated processing and control.

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Currently, at every step between two batch processes, tablet manufacturers and packagers invest labour to move product, and consume space to store work-in-progress inventory. But more importantly, at every step, the risk that a foreign tablet or foreign matter enters the product stream increases. Knowing all these, tablet manufacturers and packagers are racing to automate their production lines, and continuous processes are replacing batch processes. Bulk optical inspection systems help facilitate this paradigm shift.

In addition to assuring product quality and reducing labour, bulk optical inspection systems can be used for process control. By capturing a continuous stream of data about products on the line in real-time, this technology enables manufacturers to improve upstream operations and streamline downstream processes immediately. And in the future, harnessing this data may be useful for integrating into Process Analytical Technology (PAT) initiatives.

Selecting an Inspection System for Pharmaceutical Packaging

Beyond looking for equipment that meet FDA requirements and comply with GAMP 5 guidelines, additional selection criteria must be carefully considered – if all of the operational operational advantages outlined above are to be achieved in full capacity. The finest bulk optical inspection systems recognize subtle differences in colour, size and shape to ensure every tablet conforms to product specifications. If the system offers ultra-high resolution (defined as 0.17 mm square pixels), then the system can detect and remove foreign tablets as well as the smallest foreign matter and the smallest colour and shape defects.

This is best achieved if the system uses four cameras that are located both above and below the product stream to view the product from all sides. Such systems are currently available to inspect up to 1,000,000 tablets per hour.

Of course, the effectiveness of the bulk optical inspection system relies not only on the hardware but on the software – the algorithms – that manipulate raw data and categorize information based on the customerdefined accept/reject thresholds. The art and science of image processing lies in developing computerized routines that improve the effectiveness of the operation, while presenting a simple user-interface to the operator.

Thus, the equipment manufacturer’s experience and success with optical inspections systems for the pharmaceutical industry and tablets (in particular) - are key indicators of their ability to deliver systems that will achieve optimal performance. The equipment manufacturer must be able to assist with the development and execution of the required qualification protocols, and produce systems that comply with GAMP 4

and 21 CFR 11 requirements. Furthermore, it is important to consider the level of service that a supplier can provide in your region – from engineering to validation and after-sales support.

Conclusion

The arrival of modern bulk vision inspection systems, which have been designed specifically for tablets, is likely to transform the industry. With their effectiveness in assuring final product quality and their commercial viability – both in terms of production throughput and capital costs – such systems appeal to product manufacturers, packagers and brand owners who are looking to deliver consistently high product quality and eliminate costs from the operation.

* Courtesy: Symetix

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