Mettler-Toledo PCE offers the XMV-TE system designed to help pharmaceutical companies comply with the specifications of EU Directive 2011/62/EU governing protection against falsification. The XMV-TE combines components for serialization, tamper-evident sealing, and process monitoring. The complete system integrates into both new and existing lines and networked with data management systems.
The XMV-TE contains a marking system, which provides pharmaceutical packaging with a unique serial number for end-to-end traceability, plus a tamper-evident module that uses a safety seal to indicate potential tampering. Both procedures correspond exactly to the specifications of Directive 2011/62/EU, and the product sealing is compliant with the relevant CEN standard 16679.
At a total length of 1.5 m, all the components necessary for protection against falsification are integrated into the XMV-TE. An ink-jet labeling system prints each item of pharmaceutical packaging with a unique serial number and a Data Matrix code. A smart camera then verifies the barcode and number. The sealing module seals the tabs of the paperboard boxes with a transparent tamper-evident seal. Any attempt to open the packaging leaves behind visible traces, providing evidence of tampering. Finally, an integrated reject system collects all the packaging that has been identified as faulty—where the serial number printing has been deemed illegible, for example—in a storage container.
All of the XMV-TE’s individual components work in harmony with one another. The system is suitable for handling the highest levels of product throughput, such as that found in fully automated packaging processes. The XMV-TE is also a track-and-trace system that saves a considerable amount of space and can be integrated into both new and existing lines with ease. The XMV-TE is designed for maximum process reliability and user-friendliness: Its complete housing can be locked electromagnetically, with all components remaining easily accessible via a transparent cover. This allows maintenance, product replacement, and cleaning to be carried out quickly and easily. The system also features all the necessary connections and interfaces for integration into a line or site management system.