Uhlmann prepared 47 lines to meet the EU Falsified Medicines Directive deadline.
Salutas Pharma and its Polish affiliate LEK, both subsidiaries of Sandoz companies belonging to the Novartis Group, have spent the past two years preparing to meet the deadline for implementation of the EU Falsified Medicines Directive (FMD) (1). The project, one of the largest in the company’s history, involved 47 production lines, a tight time schedule, and equipment and expertise from Uhlmann Pac-Systeme.
As of February 2019, prescription medicines in the European Union must be marked with a unique identification number. A tamper-evident form of closure also is required. The implementation of these serialization and tamper-evidence requirements significantly impacts the pharmaceutical production process.
The Salutas sites in Barleben and Osterweddingen, Germany, are modern and efficient pharmaceutical production facilities. “Around eight billion tablets and capsules leave our Barleben plant alone in a year,” reported Kay Reinhardt, team leader Engineering Projects at Salutas Pharma, in a press release (2). Most products are marketed within the EU. Between the two sites in Germany, 26 packaging lines needed modifications.
In Poland, LEK faced a project of similar scale. Upgrading so many almost-identical lines poses a major mechanical engineering challenge. Added to this, the generics manufacturer stipulated an extremely tight time schedule to minimize costly downtime and prevent supply shortages. Salutas chose Uhlmann, which it had worked with since the 1990s, as its partner for the project. The project partners defined machine and project details in mid-2016 and drew up an ambitious implementation plan.
Salutas opted for the compact Uhlmann Serialization Platform. The module-based platform integrates weighing, printing 2D DataMatrix codes, camera-based inspection, tamper-evident labeling, and transmission of serialization data in real time to a site server. “We worked with Uhlmann to adapt the machine and the software, so everything optimally meets our requirements,” added Reinhardt in the press release.
Having finalized a pilot machine in May 2017, the actual rollout-dealing with six lines at a time -began in October 2017. As lines in Germany and Poland were put into operation, Uhlmann prepared serialization units for the next group and carried out the factory acceptance tests. Experts from both Uhlmann and Salutas provided support for the lines and information technology.
The last machine was released for production in September 2018, completing the technical installation. The teams are now concentrating on correcting any problems so that production will comply with all the EU specifications at the beginning of February 2019. Success was achieved due to good preparation; extensive testing of the pilot machine; strict adherence to the schedule; and dedicated, well-coordinated project teams.
1. EC Directive 2011/62/EU, Falsified Medicines Directive (Brussels, July 2011).
2. Uhlmann, “Uhlmann Executes Major Serialization Project for Novartis Subsidiary Salutas Pharma,” Press Release, October 2018.