Uhlmann has successfully completed a major project to retrofit serialisation solutions for a customer. 47 production lines at Salutas Pharma GmbH and its Polish sister company LEK S.A. were prepared for the requirements of the EU Falsified Medicines Directive.
Salutas Pharma and LEK are Novartis subsidiaries. As the market leader for Pharmaceutical packaging the EU anti-counterfeiting directive posed a particular challenge for them. A total of 47 packaging lines with Serialisation units are provided. There are 26 systems at the Salutas sites in Barleben and Osterweddingen alone. The Barleben plant produces eight billion tablets and capsules per year. In addition, the EU Falsified Medicines Directive requires tampering with products to be made more difficult by means of tamper-evident seals from February 2019. The implementation of this serialisation and Tamper evidence specifications means a great deal of effort for pharmaceutical companies and interference in sensitive processes.
(Image source: Uhlmann)
For the Uhlmann Pac-Systems GmbH & Co. KG, the order from Salutas and LEK was challenging. Even though the production systems were almost identical, it was a complex mechanical engineering task. The schedule was also tight in order to avoid lengthy production downtimes. Preparations began in mid-2016, when the project partners finalised the machine and project details.
Salutas opted for the compact „Uhlmann Serialisation Platform“ (USP). The modular platform has the following components: weighing, printing, inspection and Tamper-evident labelling. Serialisation is carried out by applying a 2D data matrix code to folding cartons, which is read by a camera and transmitted to a site server in real time. „We adapted the machine and the software with Uhlmann so that they optimally fulfil our requirements,“ explains Kay Reinhardt, Team Leader Engineering Projects at Salutas Pharma.
„As we have been working with Uhlmann since the 1990s, we are familiar with their project management and were convinced that we would receive the necessary support“
Kay Reinhardt, „Team Leader Engineering Projects“ at Salutas Pharma (Image: Uhlmann)
The first pilot machine was ready in May 2017. However, the actual implementation then began in October of that year. Six lines were converted in blocks of five weeks each. While the converted lines - four each in Germany and two in Poland - were being put into operation, Uhlmann prepared the next serialisation units and carried out the final tests together with the customers. Factory Acceptance Tests (FAT).
The purely technical installation has now been completed. The last finished machine was handed over at the end of September 2018. There is now still some finishing work to be done. As everyone involved is optimistic that no further imponderables will arise, it is expected that the pharmaceutical packaging companies' production will meet EU requirements in February 2019.
