Universal Appeal: Producing and packaging pharmaceuticals for global customers

R-Pharm Germany is a CMO producing and packaging pharmaceuticals for customers in more than 150 countries. In order to supply pharmaceuticals to markets that demand serialisation or aggregation, the company uses tools such as the Case Aggregation Kit from Mettler Toledo PCE on a semi-automatic case packer from Christ Packing Systems.

Serialisation from as early as 2017

Protection against falsified medicines has become the leading issue for the pharmaceutical industry in recent years. According to EU Regulation 2016/161, all pharmaceutical packaging must be serialised and fitted with an antitampering device from February 2019. The USA has also set a similar law in motion, the Drug Supply Chain Security Act (DSCSA), which requires serialisation to begin as early as 2017. Other major markets are already calling for measures to protect against product piracy.

Those wishing to export goods to China, Korea, or Saudi Arabia, for example, are already required to aggregate their pharmaceuticals. “If we are to serve these strategically important and high-volume markets, we need secure and flexible technical solutions for aggregating packaging,” said Michael Unbehaun, manager of engineering projects at R-Pharm. “Over the years, we have built up a firm partnership with Mettler Toledo PCE in the field of pharmaceutical serialisation and aggregation. Together we have been able to successfully implement a number of technological developments that focus on the production process. The first of 10 serialisation and aggregation lines was launched back in 2009 – this is why we recently opted for another semi-automatic aggregation solution from Mettler Toledo PCE.”

Customisation

R-Pharm Germany has rounded out its service portfolio with the Case Aggregation Kit – a customised OEM kit from Mettler Toledo PCE that is designed to upgrade existing packaging lines – in combination with a compatible case packer platform from Christ Packing Systems. This means that the company can now execute manual, semi-manual and fully automatic serialisation and aggregation for folding boxes, bottles and wallets. The result is a needs-based service with a highly flexible structure, which enables the customer’s production requirements to be implemented in a cost-efficient manner at all levels of aggregation. It was with this end goal in mind that the company joined forces with Mettler Toledo PCE and case packer manufacturer Christ Packing Systems in 2014 to devise a new packing line that could aggregate ready-packed, serialised, and sealed individual packages in a centralised manner. The investment decision followed an external benchmarking process, in which technology from various providers, concept designs, and the potential outlay were analysed and compared.

A semi-automatic case packer from Christ’s CaseTeq 100 product range forms the basis of the packing line. The Case Aggregation Kit from Mettler Toledo PCE – which consists of the software, cameras, control monitor, and cabinet – sits on top of this. In order to ensure that this solution would work effi ciently in three-shift operation, the individual components of the apparatus first had to be precisely coordinated with one another. “The challenge lay in ensuring that the case packer and the aggregation software could communicate with each other without any problems,” said Achim Gombert, a sales engineer at Mettler Toledo PCE. “To make this possible, we used our PCE Line Manager software and adapted the workflow to fi t the case packer.” Michael Meyer, product manager at Christ Packing Systems, said: “Thanks to our close and constructive collaboration with Mettler Toledo PCE, we were able to rapidly develop a solution that is perfectly tailored to the specific needs of R-Pharm Germany.”

Aggregation via camera

For open orders, the employees at R-Pharm manually place the bundled pharmaceuticals on a conveyor belt. The semi-automatic case packer from Christ transports the bundle past a camera, which in this case identifies preprinted serial numbers on the individual packs layer by layer and forwards the data to the PCE Line Manager software. The system then places the bundle into a box in such a way that the serial numbers are visible on the top. Once the box is completely filled, an employee applies a self-adhesive shipping label that contains the aggregation code, including the serial number and other variable data. Once the code has been verified using a handheld scanner, the software is notified that this box is full and has been labeled. This prompts the software to assign to the box all the serial numbers recorded in it. The boxes are then transported to the sealing station, where they are closed up for transport. This enables R-Pharm to ensure that the compounds and serial numbers within a specific box can be determined at any time within the supply chain. “Aggregation of boxes is not just stipulated by regulations – it also lays the foundations for a high degree of transparency and thus for the potential to improve the logistics process for our customers. This guarantees that our digitisation solutions are viable in the long term and creates benefits for patients and companies,” said Unbehaun.

Statistics and line

During the ramp-up phase for this system solution, R-Pharm made use of the log and debug files in the Line Manager software from Mettler Toledo PCE to carry out statistical evaluation, enabling the company to identify and eliminate weaknesses within the packaging process. Audit trails also allow pharmaceutical manufacturers and packers to verify that the serialisation process has complied with the regulations at every single stage and has not been manipulated. Finally, once the packaging process is complete, the Site Manager software from Mettler Toledo PCE forwards the serial numbers processed for a specific order to external platforms, run by the customer or markets, via specially configured connectors and interfaces.

The combination of the semi-automatic case packer and the Case Aggregation Kit from Mettler Toledo PCE supports R-Pharm in the efficient production of its orders. In bundle mode, 250 to 300 pharmaceutical packs per minute can be packaged and aggregated. The system is highly flexible and a single person can implement a format change in under one hour.