Serialisation and tamper evidence for pharmaceutical packs

At Fachpack 2013, which takes place in Nuremberg from 24 to 26 September, the labelling and marking specialist MULTIVAC Marking & Inspection will be presenting a labeller for pharmaceutical packs, which seals the tuck-in flaps of folding cartons with a label. This ensures that packs have tamper evidence, by which consumers can detect immediately whether the pack is unimpaired. A data matrix code for seriali-sation can be printed on the tuck-in flap by means of an inte-grated printing system.

Medicines, which are sold within the EU, must be provided by 2017 at the latest with security features, by which forgeries can be de-tected and removed from circulation. The EU Directive 2011/62/EU for combating forgeries of medicines, which was passed in July 2011, provides for such measures. The security features are to be applied to the packs by the manufacturers, and this will allow wholesalers and pharmacies to check that medicines are genuine, as well as identifying individual packs and detecting any tampering with the outer packaging. As part of this Directive, there is also a requirement for protection against tamper opening of pharmaceutical packs.

Such tamper evidence can either be implemented by an appropriate design of the folding cartons (e.g. adhesive flaps) or by the use of sealing labels. "Since the folding carton systems and the folding car-tons themselves can generally not be changed due to validation, only labelling of the folding cartons with a sealing label is available for the retrofit of existing equipment", says Udo Kästing, the specialist at MULTIVAC Marking & Inspection for applications in the pharmaceu-tical industry.

The specialised labelling and marking company from Enger is show-ing a labeller at Fachpack 2013 in Nuremberg, which applies sealing labels that are adhered over the tuck-in flaps of the folding cartons. Retailers and consumers can identify by means of the labels whether the pack has been tampered with or not.

The folding carton labeller labels from above and below at an output of up to 400 cycles per minute. The labels are subsequently pressed on over the edges, so that the tuck-in flaps are securely sealed. The presence of the sealing labels is monitored by means of a light bar-rier. Cartons without sealing labels are separated out and ejected into a lockable reject bin.

As a means of protection against product piracy, track-and-trace sys-tems are used in the EU, and also in other countries such as Austra-lia and the USA as well as countries in South America and Asia, whereby data matrix codes are printed on the side flaps of the folding cartons and these are monitored and archived by means of pharma-ceutical inspection units. For this purpose the new folding carton la-beller from MULTIVAC Marking & Inspection is equipped with a Wolke thermal inkjet printer. The data management and the monitor-ing of the data matrix code is performed by means of LAETUS in-spection units.

If required, the folding carton labeller can be equipped with an addi-tional label dispenser for applying a vignette label from above.

The balcony-type installation, which is designed to meet the re-quirements of the pharmaceutical industry, enables all functions of the folding carton labeller to be operated from the front. Thanks to the intuitive MULTIVAC HMI 2.0 user interface with 12.1" colour touchscreen, all processes can be controlled easily and the various access levels are password-protected. All operating stages can be displayed seamlessly.