E-Pedigree: How Automation Secures the Pharmaceutical Supply Chain

While some companies consider using their existing workforce to manually track and trace packages, vision systems enable serialization solutions that repeatably track every package, bundle, case and pallet. Packaging line manufacturer ESS Technologies shows how it's done.

Bottles in the inspection module
Bottles in the inspection module

The complexity of the drug distribution supply chain makes it difficult to prevent product diversion and counterfeiting. To address this problem, drug manufacturers are turning to so-called e-pedigree solutions to repeatably track every package, bundle, case and pallet. In fact, California e-pedigree legislation requires that 50 percent of pharmaceuticals shipped to the state starting in 2015 be tracked down to the individual bottle level. This requirement is particularly challenging for relatively low-volume packaging operations that are currently using automated filling and labeling machines with manual case and pallet packaging systems.

ESS Technologies (www.esstechnologies.com), a packaging line manufacturer, has partnered with Xyntek Inc. (www.xyntekinc.com), a serialization, track and trace, and machine vision system integrator, to provide a robotic case erector/loader with integrated track and trace capability. This system allows pharmaceutical and medical device manufacturers to automate the case packing process and provide unit-level serialization, traceability and authentication for all of the products being case packed.

The e-pedigree consists of an electronic record of each transaction resulting in a change in ownership of the drug from the initial sale by the manufacturer through wholesalers and distributors and pharmacies until final sale to the consumer.

Pharmaceutical manufacturers are addressing this by implementing serialization solutions that affix a unique and traceable serial number to every package, bundle, case and pallet. This serial number is read many times as the product moves from manufacturer to consumer and, each time, an entry is made in a database to document the chain of custody. Manufacturers, wholesalers and pharmacies must collaborate on the serialization strategy.

When lines are not fully automated, they typically use automated filling and labeling machines but manual case and pallet packaging systems. They operate at relatively low speeds—about three to five cases per minute, with each case containing six, 12 or 24 individual packages.

Because manual operations are inherently vulnerable to untraceable errors, making it difficult or impossible to comply with e-pedigree regulations, automation offers a solution. The ESS/Xyntek approach uses a Fanuc LR Mate 200iC/5L multi-axis robot with special end-of-arm tooling and four Cognex InSight 5603 vision systems. The vision systems provide a fast and accurate method of reading and verifying the quality of one- and two-dimensional barcodes.

Dual codes provide verification
When case packing, it’s important to determine at the moment of loading which particular bottles are going into each case. The serial number on the labels of the bottles cannot be read at this point because the bottles are bunched together, but dummy codes on the bottom of the bottles can be read easily.

So, after filling and labeling but prior to packing the bottles in cases, the Xyntek-Antares Bottle Tracking System uses the four Cognex (www.cognex.com) InSight 5603 vision systems to image all sides of the bottles. This enables the system to read the 2D DataMatrix code on the label regardless of its position, while a single InSight 5603 vision system reads the dummy barcodes on the bottom of the bottles. The serial number on the label and the dummy code on the bottom of each bottle are both entered into a database.

According to Xyntek engineers, the traditional approach to pharmaceutical serialization uses industrial cameras multiplexed to an industrial PC. These systems can be expensive to maintain and validate because of the need to maintain a complex and continually changing operating system and custom software. Xyntek selected the Cognex vision system because of its powerful, high-speed processer and the fact that it operates independent of a PC (which provides increased stability with less frequent updates and maintenance).

Cognex offers a large library of vision tools that can be used for code reading and other operations without programming.  With the bottles arranged in a 4x3 pattern, and each bottle having a 2-inch diameter, a 6x8-inch field of view is needed to read the code on the bottom of all 12 bottles. At 1,600x1,200 pixel resolution, a single InSight 5603 can consistently read all 12 bottles within the time requirement.

The bottles come into the robotic cell on a conveyor and a servo device forms them into a pattern based on the type of container. The robot then picks up all bottles and loads them into the case. Vacuum sensors on the end-of-arm tooling check for the presence of each bottle and, if a bottle is missing, set off an error signal. Vacuum cups pick up a case blank from a magazine. The robot can use either regular slotted container (RSC) cases that are normally used in manual operations, or wraparound cases that are common in automated processes.

As the robot moves the bottles toward the case, it passes them over an InSight 5603 vision system that reads the dummy codes on the bottom of the bottles. Because these dummy codes have already been aggregated to the serial number of each bottle as recorded on the label, reading them makes it possible to identify the unique serial number of the bottle. This aggregation enables 100 percent verification of the bottles as they are packed into the case.

The robot loads the bottles into the case and then folds the minor and major flaps and seals the container with tape. The Xyntek-Antares Tracking System software confirms the unique serial numbers based on the pack pattern and prints a case label to complete the bottle-to-case aggregation.

If the operation fails because a bottle is missing in the tooling or because a label could not be read, the line stops. If the operation is running 12 packs, then there are only 24 bottles to rework, which can quickly be performed by the line operator.

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