Offline coding a solution to FMD compliance

Code inspection on pharmaceutical packaging will become more important when the Falsified Medicines Directive becomes compulsoryPyrotec PackMark recently reminded pharmaceutical manufacturers who sell their products on the European market about the Falsified Medicines Directive (FMD). Producers will have to comply with this legislation from January 2016.

The directive aims to decrease the number of counterfeit medicines infiltrating the legal pharmaceutical supply chain in Europe. Under the FMD, all pharmaceutical packs sold in Europe are required to carry machine-readable 2D datamatrix codes, manufacturer product codes, expiry dates and batch numbers.

These 2D codes will be verified via a camera-based system and there is a risk that blurry or slightly out-of-position codes will be unreadable, leading to those packs being rejected.

This puts tremendous pressure on manufacturers who do not have inline coding systems capable of producing these codes at high speeds. Mechanisms for inspecting codes and rejecting problem packs will also become more necessary.

Affordable coding

Pyrotec PackMark points out manufacturers do not have to upgrade their production lines at great expense. One solution is for manufacturers to opt for an offline coding and inspection system that enables them to comply with the legislation without impacting their existing production lines.

Rotech Machines indicates that the cost of complying with FMD through an offline system is less costly and far less disruptive than the cost of re-engineering an online system. ‘Based on experience, it can take several months to decide on your equipment supplier, then up to a year to set up and test a new line,’ reports a spokesperson for Rotech Machines. 

‘An offline system is independent of the production line and can be up and running in a matter of weeks.’

By taking this process offline, cartons are brought to the line ready printed and inspected, eliminating delays due to coding issues. The potential for rejects can be significantly reduced because cartons can be presented to the printer in the most favourable orientation. ‘For example, an offline system will print cartons flat, so there are no problems with mis-codes on bulging end flaps,’ says the spokesperson. 

Pyrotec PackMark offers a range of offline coding systems from Rotech Machines and Markem-Imaje that incorporates printing, labelling, inspection and automatic stack-to-stack feeding technology.

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