Laetus helps Lilly get a jump on the regulation

Published: 19-Jan-2012

On 1 January 2011, the nine packaging lines of the Fegersheim Lilly site had to be ready to comply with the new regulation on the move to the CIP 13 and the DataMatrix code

It was a worldwide first for the Lilly pharmaceutical group. In mid-October, its Alsatian plant in Fegersheim produced its first commercial lots of a growth hormone with a data matrix code printed on the case. These lots were destined for the French market, which imposed this new code beginning on 1 January 2011. The Lilly group therefore had a good lead on the regulation changes.

But it still had eight other packaging lines to equip, in particular those that produce the group’s famous insulins, which are its leading product. In Fegersheim, Lilly consciously chosen this hormone production line to ‘make a name for itself’, given its lower production rates, before taking on the insulin.

The arrival of the dataMatrix code on the scene is the result of the move from a CIP 7 code to a CIP 13 code, since the traditional barcode could no longer contain a 13-digit note while preserving a reasonable size. Moreover, dataMatrix offers the possibility of accommodating a very significant amount of data, beginning with the lot number, an expiration date, and maybe one day a serial number (the infamous serialisation). All of this information will be permanently accessible using a barcode scanner, by operators on the production lines as well as players in the supply chain, and dispensing pharmacists at the end of the chain.

Moreover, by anticipating the entry into force of the regulation, Lilly offered pharmacies the possibility to familiarise themselves with this new code and begin to equip themselves with specific readers, knowing that the case continues (and will continue) to bear the three notes in clear in case the dataMatrix code cannot be read.

Of the nine secondary packaging lines at the Alsatian site, the growth hormone packaging line was therefore the first to be equipped. ‘The investment goes back to May 2008,’ recalls Magali Joint. ‘At that time, our project was aiming to install a laser printing system for dataMatrix and the viewing system necessary for its verification. But we took advantage of the chance to change the obsolete checkweigher and the stamper.’

It should be noted that the choice of the laser printer, which burns the case, rather than ink jet printing is a recommendation from Lilly Monde. ‘This technology holds up better over time and it is more difficult to counterfeit. The technology is certainly more expensive to purchase. But it requires very little maintenance. Every two years, change the CO2 cartridge,’ justifies Joint.

For this investment, two major players on the vision market were consulted. But it was the German Laetus group that won the day for several reasons, in particular the ability of its vision cameras to offer the lowest rate of false rejections on the market. ‘We produce the fewest false rejections. Those are good products rejected for bad reasons,’ explains Robert Van Roostselaar, sales manager for Laetus France. ‘We are well beyond the 1 per 1,000 stipulated in the Lilly specifications.’

Laetus’s secret lies in the use of powerful algorithms that are capable of processing more information, more quickly. ‘;That’s what has made our reputation,’ adds Roostselaar.

Joint also emphasises the convenience of its operator interface, which makes it possible to manage the vision as well as laser marking (provided by Domino), the weighing system (provided by Gravens) and the stamper.

It should be noted that the DataMatrix code is not new for Lilly, since it already uses this code through pre-printed labels. The novelty is the ability to print it online on the cases.

This first experiment having been successful, Lilly planned to equip its other packaging lines right away. Two months later it was the insulin cartridge lines and after six months the pen injector lines, which are fitted out with a system for dataMatrix printing on their cases. Joint made certain that by August 2010, all of the Fegersheim lines were equipped.

For a pharmaceutical laboratory, the passage to DataMatrix, which in general costs €50,000 per production line, represents a very significant investment. Thus van Roostselaar observes that many players, in particular third party manufacturers, gather information, but don’t follow up. The result: Mr. Roostselaar expected a difficult autumn in 2010. ‘In France, there are only maybe 20 or so technicians capable of doing this installation work. But by 2011, we had to equip 900 lines and installing this type of system takes a week of work,’ he adds. In any case, while there may be some latecomers, Lilly was one of the good students and was in compliance with the regulation in time.

Fegersheim’s key figures
#1 production site of the group, very close to Strasburg (Alsace)
1,750 collaborators
280 million invested from 2003-2009
45% of employees have pursued higher education, including 145 engineers, 80 doctors of pharmacy and 40 PhDs
145 million units produced in 2007, disposable pens and drugs in cartridges: insulin, growth hormones and parathyroid hormones, anticancer agents
92% of products are exported to more than 100 countries on 5 continents

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