©Takeda Pharma Vertrieb GmbH & Co. KG / vfa

©Takeda Pharma Vertrieb GmbH & Co. KG / vfa

Firmly glued - for safer drug packaging

To the tune of 10% of drugs are counterfeits.

The task set in the original directive 001/83/EG initially sounds complicated. The legalese explains it is about “creating a Community code for human drugs with a view to preventing counterfeit drugs from penetrating the legal supply chain.” In a nutshell: it is about counterfeit proofing for drugs. Because “in the European Union there is disturbing rise in the number of drugs found to be counterfeits in terms of their identity, their production or their origin.” These days, counterfeits can hardly be distinguished from original drugs any longer and therefore often end up with patients via the legal supply chain.
 © Boehringer Ingelheim Pharma GmbH & Co. KG / vfa

The Anti-Counterfeiting Directive 2011/62/EU requires a great deal of action from pharmaceutical product producers and packaging manufacturers. © Boehringer Ingelheim Pharma GmbH & Co. KG / vfa

Verify authenticity

The new European Directive 2011/62/EU will enter into full force in 2019.  © Merck KGaA / vfa

The new European Directive 2011/62/EU will enter into full force in 2019. © Merck KGaA / vfa

The amended Anti-Counterfeiting Directive 2011/62/EU explicitly states that from 2019 all drug packaging must be equipped with safety features. Prescription drugs must be labelled with a unique identifier from that date, permitting unambiguous traceability. It must contain the drug manufacturer’s code, a serial number, a national number for reimbursement, the batch number and the expiry date.

Furthermore, an anti-tampering feature must indicate that the packaging unit has not been opened. According to the Anti-Counterfeiting Directive, there will be four safe closing options available as secondary packaging materials for folding boxing from 2019: closing with glues, special folding glue constructions, closing with sealing labels and sealing with film.

Glueing without getting stuck

In September 2015 the customs investigations office in Essen seized forged drugs worth  € 3.2 m.  © Merck KGaA / vfa

In September 2015 the customs investigations office in Essen seized forged drugs worth
€ 3.2 m. © Merck KGaA / vfa

Glued closures offer not one but several advantages: they are low cost, the application of glue does not impact the uptime of the packaging line and the packaging design is not interfered with. Additionally, various glue types with different properties can be used and even combined, says Andreas Brandt from the Krefeld firm “Baumer hhs”. Suitable for use is hot glue, PU hot glue, cold glue or even a combination of glues. Every layer of glue applied has to be examined. This is why the specialists not only offer their core competencies for glue application but also quality assurance systems working according to the fail-safe principle. To attain the highest safety possible the folding boxes undergo not one but a series of safety checks.
When folding boxes have been opened this is easy to detect by the fibres torn from of the box surface. © Baumer hhs

When folding boxes have been opened this is easy to detect by the fibres torn from of the box surface. © Baumer hhs

© Baumer hhs

The so-called two-shot process combines hot and cold glue. The hot glue serves to quickly close the folding box while the cold glue ensures permanent, irreversible contact. © Baumer hhs

TIGHTLY PACKED

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