A European group of experts is currently working on a CEN standard for tamper-evident closures on medicine packaging. The Edelmann Group is represented and has taken on a leading role.

The backdrop to these endeavours are the so-called guidelines against counterfeiting for pharmaceuticals packaging approved by the EU in 2011. Besides the inclusion of security features, they also call for measures to safeguard originality: They should allow dispensing chemists to see whether packaging has already been opened and possibly had its contents exchanged. Because the guidelines do not specify the corresponding features, German pharmaceuticals companies and associations, as well as packaging companies have taken the initiative to specify the technicalities.

The basis is a DIN (German Institute for Standardisation) draft that was previously created by a German working group. The European working group will publish an initial draft this year. The Edelmann Group is represented in both working groups, contributing its expertise in the area of pharmaceuticals packaging.

Edelmann sees advantages in terms of manipulation prevention in particular among folding cartons with constructive tamper-evident closures. Due to their construction, they can only be sealed once and then cannot be opened again without visible damage.  “No further tools are required in this case to check for manipulation,” explains Meino Adam, Head of Packaging Development for Health Care at the Edelmann Group. “Through the CElock system, which has been registered for a patent, we already have folding carton designs in our portfolio that work accordingly.”

In terms of packaging technology, the CElock system is special as tabs are torn along a perforated line upon opening. This means that the original act of opening remains visible. The system was recently used again in the packaging solution realised by Edelmann for the blood-pressure reducer Sevikar, a product from the Japanese pharmaceuticals producer, Daiichi Sankyo.