Detecting fakes with packaging

Counterfeiting of medicines and some food product is rapidly increasing, which is resulting in not only billions of dollars lost through piracy but also creating health and safety risks. Researchers are therefore developing authenticity seals and security codes intended to make packaging uniquely identifiable.

In Germany, anyone who buys Sinupret sinusitis tablets from pharmaceuticals producer Bionorica will now see on the folding carton a three-dimensional, optically variable, embossed mark which can be seen when the carton is tilted. In view of the fact that the herbal medicine was so often copied, the company engaged Munich-based Giesecke & Devrient, which specialises in printing bank notes, to design this tangible security feature for the product’s packaging. By the end of 2011, Bionorica intends to emboss the packagings of all its product ranges with the new quality seal.

Producers who have problems with counterfeiters must make their products uniquely identifiable. This is especially true in the pharmaceuticals sector. “The danger of counterfeit medicines is growing,” says Ulrike Holzgrabe of the German Pharmaceutical Society (DphG).

The internet is a weak spot

According to EU figures, in 2009, the German customs authorities seized counterfeit medicines to the value of 11.5 million euros - 30% more than the previous year. Also, a World Health Organisation (WHO) study claims that even in supposedly safe regions such as Europe and the US, up to 10% of all medicaments are counterfeit.

The mail order business sector is booming and it is apparently becoming harder for consumers to distinguish between reputable mail order pharmacies and illegal traders. Test purchases by the Central Laboratory of German Pharmacists confirm counterfeiting rates of 50% for medicines sold by, for example, illegal internet pharmacies.

“Producers of pharmaceuticals are therefore more willing to look at methods of providing better security against counterfeiting,” says Holzgrabe.

The companies have two aims: firstly, consumers should be able to verify that they have received an original product; and secondly, experts should be able to identify counterfeits when they carry out checks.

Bayer Healthcare explains on its website (www.vorsicht-faelschung.de) how patients can distinguish between original Bayer preparations and imitations. In future, the company will also provide its medicament packaging with counterfeit-proof features.

Security based on banknote printing

In Germany, Artur Theis is a specialist of folding cartons that cannot be copied. “Our task is to make the security features suitable for a folding carton production line, and then for series production,” explains Ulrich Dörstelmann, head of the counterfeiting security department at the Edelmann subsidiary.

The conditions in its Wuppertal plant, which has been converted into a pure counterfeiting security facility, are the same as those in a banknote printing works. There is strict access control to the production section, the security zones are taboo for most of the personnel and all processes are exactly documented and archived. The degree of meticulousness is said to be so far unique in the German packaging industry.

Bayer Healthcare engaged the services of Artur Theis resulting in, says Dörstelmann, a sort of lenticular image that cannot be imitated by counterfeiters. “We combine printing and embossing technology and use UV security inks.”

Figure 1: The lenticular image makes counterfeiting much more difficult. Artur Theis, a subsidiary of the Edelmann Group, developed the production process for the new packaging. The mark is printed and embossed by Braun Pharmadruck - also an Edelmann subsidiary - in Bitterfeld.

Track and trace

The EU, however, requires yet another step to be taken by the pharmaceuticals industry to ensure greater patient safety. Industry Commissar Günter Verheugen announced that in 2011 there will be a standard procedure at EU level in the fight against the counterfeiting of medicines.

In 2008, the commission proposed that medicament packaging should be protected by a security mark, and that in future it should be possible to retrace their path from the counter back to the factory.

The WHO is also a strong supporter of counterfeit-proof labelling. Producers of pharmaceuticals are therefore pushing for the introduction of an electronic proof of origin in the form of a track and trace system which can monitor the complete supply chain.

In order to test and demonstrate coding and identification solutions, the European Federation of Pharmaceutical Industries and Associations (EFPIA) launched a pilot project in Sweden in September 2009. For several weeks, medicament packaging of 25 pharmacies in the Stockholm region were provided with a two-dimensional data matrix code. This code can hold more information than a simple barcode, and in the Swedish project, it contained an article number, a batch number, a use-by date and a serial number. At the pharmacy, the code was scanned and compared immediately with an entry in a database. The whole process took only a few seconds, so that counterfeits were immediately identified. Only after this security check did the customer receive the medicament. About 100,000 medicament packaging items were tested using this system - with great success, as the EFPIA reported.

Experts therefore confidently expect the track and trace system to be implemented throughout Europe in the near future. “The EU’s pharmaceuticals package could become law in 2010,” says Dörstelmann.

Manufacturers of machinery and systems are well prepared for a switchover. Optima Group Pharma, for example, based in the Swabian town of Schwäbisch Hall, specialises in filling and sealing syringes and vials. It already offers, on request, coordinated track and trace solutions for producers of pharmaceuticals.

“Ready-to-use syringes are stored and transported in special syringe nests in plastic boxes referred to as tubs. Our machines label the containers, so that they can be traced at any time,” explains company spokesman Henning Felix.

Figure 2: Syringes are nested and then packaged in tubs. Optima Group can print codes on these plastic boxes.

Bosch Packaging Technology, which supplies filling, processing and packaging technology for the pharmaceuticals industry, also has printing and tracing equipment in its portfolio. Bosch Product Manager Daniel Sanwald explains the function of the printing module as follows: each minute, up to 400 folding cartons are transported on a conveyor belt at high speed through a printer, which labels each carton with a data matrix code containing a production number, use-by date and serial number. A camera subsequently checks and verifies the code. The data are finally stored on a high-capacity central server, from which they can always be called up. If a product that cannot be identified in this way turns up in a pharmacy, it must be a counterfeit.

Figure 3: Bosch has developed a system that can print a track and trace code on up to 400 packagings per minute.

Figure 4: Original or fake?

“If track and trace becomes mandatory, thousands of production lines will have to be retooled. We can see enormous market potential for our technology,” says Sanwald. However, it is yet to be clarified where all the data associated with a track and trace system should be stored.

It is unlikely that pharmaceuticals counterfeiters will be attracted by medicaments that have been provided with a security mark, a code and a top-quality packaging. However, there are still many obstacles on the path to obtaining maximum patent protection. An enormous investment is required in order to retool packaging lines, and this could prevent pharmaceuticals companies from acting quickly. Even if the EU rapidly approves its pharmaceuticals package, the implementation process could take years.

Manufacturers of machinery and systems will present their track and trace solutions at Interpack 2011 in Düsseldorf Germany from 12 to 18 May 2011. For further information go to www.interpack.com.