Serialization solutions enabling easy tractability and tracking of individual product packages.
R-Pharm Germany GmbH in Illertissen operates as a contract manufacturing organization (CMO), producing and packaging pharmaceuticals for customers which are then distributed in more than 150 countries. In order to supply pharmaceuticals to markets that demand serialization 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.
Serialization 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 serialized and fitted with an anti-tampering device from February 2019. The USA has also set a similar law in motion, the Drug Supply Chain Security Act (DSCSA), which requires serialization 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.
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“If we are to serve these strategically important and highvolume markets, we need secure and flexible technical solutions for aggregating packaging,” explains 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 serialization and aggregation. Together we have been able to successfully implement a number of technological developments that focus on the production process. The first of ten serialization and aggregation lines was launched back in 2009 – this is why we recently opted for another semiautomatic aggregation solution from METTLER TOLEDO PCE.”
Customizing for Perfect Processes
R-Pharm Germany GmbH has rounded out its service portfolio with the Case Aggregation Kit – the new aggregation solution from METTLER TOLEDO PCE – 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 serialization 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 cost-efficiently 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, serialized, and sealed individual packages in a centralized manner. The investment decision followed an external benchmarking process, in which technology from various providers, concept designs, and the potential outlay were analyzed and compared.