The serialisation work station has been developed by Masterprint Kft. particularly for the purposes of pharmaceutical industry players – while the general idea behind making medications fully trackable is to eliminate the chances for selling counterfeit products.
17 billion boxes of medicinal products – this is the annual number of mostly prescription only medications impacted by the new rules within the European Union, entering into force on 9 February 2019. The objective set for the new EU FMD Decree is to minimise the number of abuses committed with pharmaceutical products, and to eliminate the presence of counterfeit products on the market. Therefore, upon the expiry of the deadline set, only prescription medication, which are fully trackable, based on the unique ID number placed on the box will be allowed to be traded within the EU, while the so called Tamper Evident label, which is a safety foil, is meant to ensure that product packaging remains intact.
To enable the pharmaceutical producers to integrate the strict new EU regulations into their running production processes smoothly, they need to make significant investments in the IT, technical, and organisational areas as well. Masterprint Kft. has developed an enhanced serialisation work station to manage this complex task.
The Masterprint PharmaJet Print & Check Tamper Evident machine is a high speed labeling – verification – validation serialisation work station, which will enable pharmaceutical producers, marketing authorisation holders, and trading companies to ensure full compliance with the new EU Directive. The work station has a modular structure, meaning that both the hardware part and the software part to be interlinked with the overall EU IT system can be adjusted to individual needs, in line with the customer’s specific needs and expectations. The objective is to ensure that customers are able to switch over to the new structure by minimising the changes required to be implemented to their current systems, with the need to integrate the steps required by the strict new EU legislation into the running production processes. The state of the art IT platform on which the equipment operates provides a solution from level L1 to L4, covering the entire process range. Our highly qualified team of engineers will provide up-to-date support to our customers on site, or via remote assistance. The Tamper Evident label is meant to ensure that the product packaging remains intact, and this function can be added to the equipment’s existing functions. A new function, which is our own development, is the verification of the position of the Tamper Evident labels, via the built-in camera system. We will design and produce all equipment required to facilitate compatibility with the customer’s already running systems. The Masterprint PharmaJet Print & Check Tamper Evident machine enables a fully automated pharmaceutical serialisation process.
Due to the high speed printing feature, the serialisation process will not slow down the manufacturing process, while the operational and maintenance costs can be kept low.