Mettler-Toledo PCE has unveiled the new complete XMV-TE system, designed to help pharmaceutical companies comply with all the specifications of EU Directive 2011/62/EU governing protection against falsification. The XMV-TE combines components for serialization, tamper evidence sealing and process monitoring. The complete system can be easily integrated into both new and existing lines, and networked with data management systems. Mettler-Toledo PCE also presented the XMV-TE at ACHEMA 2015 in Frankfurt, Germany (15-19 June, Hall 3.1, Stand H27).
The complete XMV-TE system contains a marking system, which provides pharmaceutical packaging with a unique serial number for end-to-end traceability, plus a tamper evidence module that uses a safety seal to indicate potential attempted tampering. Both procedures correspond exactly to the specifications of Directive 2011/62/EU, governing the prevention of falsification – and what is more, the product sealing is compliant with the relevant CEN standard 16679. The technology helps pharmaceutical manufacturers implement all the specifications of the EU Directive in a timely manner before they come into force, as well as enabling their production to adapt flexibly to the track & trace specifications of numerous other countries.
"All pharmaceutical companies whose target markets are in the EU must be ready to serialize their products and protect them from manipulation, at the exact point when this is required. Anyone who isn’t prepared risks losing their ability to supply goods – or faces costly stock repackaging once the specifications take effect", says Reinhold van Ackeren, head of marketing & product management at Mettler-Toledo PCE. "With the XMV-TE, companies can produce goods that are already compliant with regulations, and can immediately benefit from outstanding protection against falsification in their preparations."
At a total length of only 1.5m, all the components necessary for protection against falsification are integrated into the XMV-TE. An inkjet 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 that comes next seals the tabs of the cardboard boxes with a transparent tamper evidence 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 perfect harmony with one another. The system is suitable for handling the very highest levels of product throughput, of the kind usually found in fully automated packaging processes, for instance. The XMV-TE is also a track & trace solution which 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 with ease. The system also features all the necessary connections and interfaces for integration into a line or site management system.
EU Directive 2011/62/EU aims to prevent falsification of pharmaceutical products and applies to the majority of prescription medication. In the case of every pharmaceutical product, it requires unambiguous identifiability by means of a unique serial number. It also stipulates measures to verify the integrity of the packaging; these are defined in greater detail in the CEN standard 16679. The delegated acts relating to EU Directive 2011/62/EU are scheduled for publication at the end of 2015.