Marking and coding system tracks pharmaceuticals' journey to customers

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Marking and coding system tracks pharmaceuticals' journey to customers
9/1/2008
John Kalkowski
Packaging Digest

With billions of prescription pills and tablets being packaged and shipped around the world each year, it would be easy to slip in a few tens of thousands of counterfeit pieces or divert a couple shipments of expensive medications to a black market in another country. The existing systems just haven't had the capacity to effectively track all products through the supply chain. This may be changing.

Governments around the world are instituting regulations to manage counterfeiting, diversion and reimbursement fraud while improving manufacturing quality control. These rules and guidelines often require the printing and encoding of unique data that go right onto the package, causing pharmaceutical companies and contract packagers to scramble in order to meet all the requirements of every jurisdiction where they may be shipping their products. In effect, they are establishing an Ïelectronic pedigreeÓ for the prescription drugs.

Many of these companies have little experience or understanding of how to build complex data structures that must be read and verified in the production process and then manage the massive amounts of data to effectively track the delivery of medications to the consumer andÛif necessaryÛtrace the product through the entire supply chain.

One Dutch contract packager has decided to be proactive. Tjoapack (www.meditraq.eu), with plants in Emmen and Boskoop, Holland, has developed a fully operational packaging line that is able to code and mark pharmaceutical packaging beginning with a single tablet in a blister-pack, all the way to the carton, case and pallet levels.

Erik Tjoa, owner of the business, says there is no legal requirement to code individual doses, but being able to print and record 6 levels of package identification is what makes his operation unique in the world. It also provides product authentification at each node in the supply chain.

Using a line management system developed by Domino (www.domino-printing.com) and its subsidiary, Control (www.controlsoftware.net), Tjoapack has installed this updated equipment on an existing packaging line that had already been validated for use with pharmaceutical products. They call it the MeditraQ Centre of Excellence.

ÏI have had a personal interest in the potential of barcoding since the formation of the company and have wanted to impact the development of its use in the pharmaceutical industry,Ó Tjoa said.

Bob Lilley, Control's director of global solutions, says the new system was designed to deal with the threat of counterfeit medicines and medication errors to improve patient safety, while helping to eliminate inefficiencies in the supply chain.

This new capability moves Tjoapack to a higher level than competing contract packagers, according to Tjoa. The system relies on 2D bar codes called Data Matrix that are printed on the package at each progressive step in the packaging process.

These codes can include a significant amount of data in a small printed space that fits on vials, ampules, blister-strips, small jars and pharmaceutical packs. The data include a product code, serial number, batch number and expiration date. In addition to the Data Matrix codes, the information can be printed in linear bar codes or on radio frequency identification (RFID) tags.

Unique codes are imprinted along with human-readable information by digital printers after the blister- pouch is made, when the blister- pack is placed in a a carton, when cartons are loaded into a case (which might include an RFID tag) and when an RFID tag is applied to a pallet of filled cases.
System verifies codes
The system has a series of checks that verify that the codes are accurate. It's not enough to have software to simply record the data, says Tony Walsh, Control's director of strategic business development. The information must be linked or aggregated and a parent/child relationship established at each step (blister-pouch to blister-strip, blister-strip to carton, etc.).

Walsh says Control has designed its software to work with any hardware technology, while also providing seamless integration with existing enterprise software systems. Control also provides compliant storage of all production data, with online access controlled by the pharmaceutical companies that own the data.

The entire system was developed to match the variable production speeds of the packaging line. At several steps in the process, Cognex (www.cognex.com) imaging stations capture the imprinted data and feed it to the Domino controller, which compares the data to make sure it is properly associated. If the data do not match, the pack, carton or case will be rejected, and the system records which medications were removed and reports ÏwastedÓ codes to ensure accurate data.

Packaging line operators at Tjoapack said that there was an initial expectation that the reject controls would slow the system. However, they said they used the data to identify problems and have been able to tweak their system to minimize downtime and waste.

ÏWe want to be the leanest, meanest and best contract packager in Europe,Ó Tjoa says.
Easy setup
Tjoapack prescription packaging runs can vary widely in length, with many being relatively short. Quick changeover and easy setup is especially important in the clean-room environments required for pharmaceutical packaging. Operators says they appreciate the Control system's ease of setup.

Tjoapack decided to implement this system on an existing line that includes a Romaco (www.romaco.com) blister-packer and intermittent motion cartoner, as well as a Sollas (www.sollas.com) bundle wrapper and a Toshiba (www.toshiba.com) Tec thermal printer.

In the process, they added 5 Cognex imaging stations with lighting, two Domino reject stations and one extraction unit, a Domino laser printer and two Zebra (www.zebra.com) thermal-transfer RFID printers. A Sick (www.sick.com) bar-code scanner was added at the cartoner and a Sick RFID station was installed at the palletizer.

Tjoa says the implentation was completed within 8 weeks of the decision to go forward. ÏThe process was not easy, but it succefully exceeds all of our expectations,Ó he adds.

He explains that he chose Domino and Control as partners because the two companies complement each other so well in terms of coding skills and experience.

Tjoapack is ahead of the game right now, the owner says. However, the size of the counterfeiting and fraud problems are so large that governments just can't ignore them. In Europe, he says, it is estimated that 7 to 15 percent of all prescription drugs dispensed are fake. In countries like Russia and China the estimates are up to 25 percent.
Tjoa points out that Turkey is poised to launch some of the world's toughest regulations on track-and-trace coding in 2009. The driver there is massive fraud in drug reimbursements. Many pharmaceutical companies and contract packagers won't be totally ready for the change, he says.

With most of its customers within a 1,000-km radius, Tjoapack works hard to provide just-in-time, lean manufacturing. The packager, however, relies on the integrated software system to generate accurate mass serialization in multiple languages while meeting local requirements at all times.

Tjoa says his company will expand into Spain and Hungary soon and is likely to install similar systems there, since demand will grow for more complete coding and data tracking.