4-in-1 System Helps Pharma Company Meet FMD Serialization Requirements
As the deadline for compliance with the EU’s Falsified Medicines Directive looms closer (February 9th 2019 if you’re wondering), pharmaceutical companies must take action now or risk being unable to supply their products in the future.
The Directive stipulates that all prescribed medicines placed on the EU market must be labelled with two safety features: a 2D data matrix code containing a unique serial number and an anti-tampering device.
One company already up to speed is Krewel Meuselbach GmbH after installing a Mettler Toledo XS2 MV TE system at its Eitorf site in the North Rhine-Westphalia state of Germany.
Global Traceability and Prevention of Product Falsification
The space-saving XS2 MV TE combines four processes in one – checkweighing, serialisation, optical code verification and a tamper-evident seal applicator.
The weighing unit ensures the completeness of pharmaceutical packaging. If contents are missing, a product is automatically removed from the production line by an air jet. Furthermore, once a data matrix code and plain text have been printed on the carton, a camera monitors the printing process and rejects products that fail to meet the company’s quality requirements.
Alongside the data matrix code, an additional tamper-evident seal on the packaging protects the product against falsification. Self-adhesive sticker seals are attached to both tab openings before the packaging is sealed. After this, sensors check if the seals have been correctly applied and the box is secure.
“The XS2 MV TE system has proven to be a reliable solution that meets our requirements when it comes to safety markings and tamper-evident seals. What’s more, it integrates perfectly into our existing production environment,” explains the Head of Krewel Meuselbach’s Technical Department Hilmar Höhne.
Krewel Meuselbach produces a wide range of products to treat depression and disorders of the central nervous system, as well as pain relief and cold and flu medicines, which the manufacturer sells internationally. The XS2 MV TE system is installed on a thermoforming line.
PCE Software Suite
In addition the company uses PCE Line Manager directly for all its line management operations. The specialist software from Mettler Toledo stores and processes 20 different packaging formats used by the company, as well as printed codes, serial numbers and image information.
PCE Site Manager also provides information about the production process, such as output, product and packaging quality and coding. The software can be connected directly to the company’s production database, ensuring comprehensive production line management.
To read Krewel Meuselbach GmbH case study in full please click here.
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