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Optical track-and-trace approach meets US pharma regulations

Omega Design, a packaging machinery manufacturer located in Pennsylvania, US, has developed a track-and-trace approach for pharmaceutical packaging lines to meet the latest regulations in the US imposed by the FDA.

'The primary goal of FDA standards and e-pedigree laws are to protect consumers from contaminated medicine and counterfeit drugs,' commented John Scholes, special projects manager for Omega Design. 'To do this, companies must keep track of their products along the supply chain down to the unit or container level. Although compliance dates and final standards are constantly changing and vary per state, the pharmaceutical industry widely accepts that the definitive requirement will involve serialisation. The new approach described here is a cost effective, easy-to-implement method of incorporating 2D data matrix serialisation within new and existing packaging lines without compromising machine speeds or accuracy.'

Most pharmaceutical companies use radio frequency identification (RFID) tags for higher levels of packaging such as pallets and boxes. However, using RFID tags at the container and bundle level substantially increases packaging costs. Omega's unscramble system utilises a serialised side label and a unique synchronised marking on the bottom of each container. This approach offers the advantage of using low-cost printed labels while being able to identify the actual containers within bundled labels. 

The system uses two Cognex In-Sight ID readers to read data matrix codes while keeping up with a line that runs at 50 to 300 bottles per minute. Omega unscramblers print and verify a unique ID on the bottom of every empty container. This ID contains enough information to keep track of the container temporarily on the packaging line. Once a larger, permanent and fully serialised label is applied to the container, a camera and serialised software management system put the label code and bottom code in sync. When it's time for final packaging, the shrink bundler groups and wraps the specified number of containers into a bundle. A robot lifts each bundle and passes it over another ID reader that identifies the containers in the bundle. A new label is then placed on the bundle that is linked to each package.

The bundler provides an even more challenging application, because the ID reader must read all of the bottles in the bundle with one image. 'Cognex In-Sight ID readers meet the challenging requirements of the application, such as being able to read the 12 unique bottom codes at a time while the bundle is held by a robot,' said Scholes.

System developer Krempien+Petersen Qualitäts-Kontrollsysteme (K+P) is also using Cognex's In-Sight 5410 ID readers to verify printed ID data on pharmaceutical packaging.


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