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Pharmaceutical Manufacturing and Packing Sourcer

Value Protection

Anti-counterfeiting and traceability features are often confused, especially with the current serialisation and e-Pedigree programmes under discussion in some countries, and the various claims to be able to uncover counterfeits. Anti-counterfeiting and traceability are different issues, requiring different solutions. On the one hand, traceability demands standardisation and interoperability amongst the various manufacturers and the intervening third parties within the supply chain up to the dispensing point; on the other, anticounterfeiting features, especially covert ones, need secrecy and confidentiality. They should be constantly kept in step with the technological advances of the counterfeiters. They are the sole responsibility of each individual branded product’s manufacturer, and they cannot be standardised.

WHAT SHOULD BE PROTECTED?

If fraudulent business is generated through sales of a mix of genuine and fake medicines in a reprocessed genuine secondary packaging, marking the secondary packaging with visible security features or visible coding does not offer sufficient protection. Moreover, at the end of the day, patients will consume the medicine, not the packaging. That is why many pharmaceutical manufacturers are now looking for solutions to authenticate the tablets, for example, and thereby complement the security features in the packaging and labelling.

SECURITY FEATURES VISIBLE OR INVISIBLE TO THE NAKED EYE?

Many pharmaceutical companies have added visible security features to their packaging to prevent counterfeiting. These include holograms, kinegrams, embossing, micro printing, moiré or special ink, such as optical variable ink. However, these visible features not only provide minimal security, but they also require training for effective authentication when faced with fraudulent reproductions of such visible security features (1).

The use of ‘covert’ features invisible to the naked eye produces a higher level of protection, due to the inability of counterfeiters to identify the presence of such features, and their consequent inability to attack them. Covert security should never be disclosed and, to prevent leaks, they should only be known to a limited number of trustworthy persons.

The best known covert security solution is invisible ink, such as UV ink (visible under ultraviolet light) or IR ink (visible under infrared light). To authenticate these inks, a lamp which emits light in the required wavelength range will suffice. The drawback of these inks is that they are readily available to anyone. There are other chemical tracers or ink additives providing security against counterfeiting, such as DNA or magnetic tracers which provide higher security by relying on uncommon dedicated verification devices.

The problem with such special inks, ink additives or taggants resides in the related logistics and manufacturing procedures, such as press cleaning, temperature- and pressure-sensitivity, as well as interaction with other chemicals. Although very efficient and effective, their implementation and deployment are quite costly. Authentication on the fly, in the retail space for example, is also difficult. All these techniques based on a security additive can be qualified as ‘analogue or hardware based’, because they require additional security elements or special substances.

Pharmaceutical packaging is produced by thousands of different printers and converters; it follows that one of the most important criteria in the selection of a security feature is its capability to be industrialised and deployed to all subcontractors. Efficient solutions should not entrain a change in the production processes, a need to acquire new machinery or to manage extra consumables which are difficult to integrate into the production process; in other words, efficient solutions should have only a minor impact on the speed and cost of production.

DIGITAL IMAGING AND SOFTWARE BREAKTHROUGH

As in other industries, the digital revolution has opened exciting new possibilities. Digital technologies can now be used to combat counterfeiting of pharmaceutical products at low cost, while providing a high level of security (2). These digital technologies are breakthroughs compared to former methods. The chemical, microor nanotechnology experts have been replaced by software engineers and digital imaging specialists.

An article in the online version of the Washington Post revealed that some manufacturers of home and office printers deliver printing equipment that adds invisible marks on each printed page, without the user’s knowledge (3). The purpose of this hidden marking is to identify printers used for fraudulent printing. Aside from the political or legal implications, this incident shows that, with today’s technology and equipment, it is possible to print invisible information with normal ink and standard printing machines.

For the packaging industry, the incident described above has an important implication: an industrial packaging printer using standard printing machines and standard ink can produce secured packaging for manufacturers of branded products using high security covert marking without additional production cost, and without reducing production speed. This latter consideration is of high importance when large volumes of items are considered.


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Roland Meylan is the co-founder of AlpVision, and currently serves as Corporate Communications Manager. He holds an MS degree in Signal Processing and Digital Communication from the Swiss Federal Institute of technology of Lausanne (EPFL), as well as a postgraduate degree in Business Administration from IMD Lausanne International Business School. Roland started his career at the graphic division of Bobst SA. He also worked in electronic communication over international data transmission networks, the forerunners of the internet. Email: avinfo@alpvision.com
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