SEA, Marchesini launch blister serialisation platform

Pharma equipment manufacturers SEA Vision and Marchesini have launched a new system that can  print, inspect and pack serialised blisters, as well as handle aggregation with cartons.

The companies note that while primary pack serialisation isn't a regulatory requirement yet in the pharmaceutical industry, it can be applied to achieve "new results in terms of safety and efficiency."

In the EU, the Falsified Medicines Directive (FMD) requires packs placed onto the market to have serialised 2D datamatrix codes with unique identifiers to be placed on secondary packaging, so it can be verified at the point of dispensing.

"This means that there is still a risk of counterfeiting when it comes to drugs' primary packaging," according to the two companies.

"Despite all the investments made by pharma companies to ensure that secondary packaging is traceable, there is still a hidden gap that could cause serious damage."

Even though there's no regulatory mandate to serialise blisters, SEA Vision and Marchesini say there is the possibility that future regulatory implementations will introduce requirements for primary packaging.

The system can also handle aggregation – linking the individually coded blisters with the codes used on packs/cartons – which can help preserve the traceability of medicines if the blisters are separated from the secondary packaging.

Meanwhile, there are some other potential benefits from going down this route, they contend.

"Another big advantage of serialising single doses is the new frontier of reading drug information through electronic leaflets, which are available by simply scanning the patient's smartphone," they said.

"Digitalisation of drug leaflets makes the information very easily accessible to patients, even when the drug has been separated from its carton box."

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