Whitepaper series: Protect medicines against counterfeiting worldwide at no extra production cost
The subcontracting of part of the manufacturing or packing of pharmaceutical products, as well as the increase of the complexity of the pharmaceutical supply chain in today’s global economy, cause more opportunities for counterfeiters to penetrate the markets with fake products, including in countries where the supply chains are well established and trustworthy. Adopting security features to protect pharmaceutical products against counterfeiting becomes necessary and must not be confused with the adoption of serialization codes used to track and trace pharmaceutical products along the supply chain. Based on software and digital imaging technology, anti-counterfeiting solutions are now available at low cost with very high security, applied to packaging, labelling, plastic containers and the tablet itself.
How to differentiate authentic products from fakes or illegally imported ones?
It is commonly admitted among specialists that packaging or labelling anti-counterfeiting features can be divided into two main categories:
• The visible or overt features.
• The features which are invisible to the naked eye or covert.
Many pharmaceutical companies have added visible security features to their packaging. These include for example holograms, kinegrams, embossing, micro printing, moiré or special ink such as optical variable ink. However, these visible features provide not only minimal security, but they also require training for effective authentication when faced with fraudulent reproductions of such visible security features.
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 is not sufficient protection.
More sophisticated techniques can be found in the field of covert security elements. That is features not visible to the naked eye and requiring dedicated detection means. The advantage of a covert element is that counterfeiters must know that there is a security element before they can attack it; on the contrary, if the security feature is visible, the point of attack is evident.
The most known covert security solution is invisible ink, such as UV ink (visible under ultra violet light) or IR ink (visible under infrared light). To authenticate these inks, a lamp emitting light in the required wavelength range is sufficient. The drawback of these inks is that they can be bought very easily on the market by anyone. There are other chemical tracers or ink additives providing security against counterfeiting, such as DNA or magnetic tracers which provide higher security as using rare and dedicated detection devices.
The problem with such special inks, ink additives or taggant 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 “analog or hardware based”, because they require additional security elements or special substances which subsequently have to be managed by the branded product manufacturer in a secured environment, involving a third party security supplier in the packaging or labelling production chain.
Digital imaging and software breakthrough
As in other industries, the digital revolution opens 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. These digital technologies are breakthroughs compared to former methods. The chemical, micro or nanotechnology experts have been replaced by software engineers and digital imaging specialists.
Cryptoglyph® invisible marking using standard printing processes
A patented covert technology now mature and already protecting billions of items worldwide is delivered by AlpVision under the name of Cryptoglyph®; it is based on software and digital imaging technologies.
Fig. 1: comparison of various overt (visible) and covert (invisible) security features with digital imaging and software based Cryptoglyph®.
The key feature of Cryptoglyph® is the regular printing with normal visible ink of a pseudo-random pattern of thousands of micro dots (10 to 50 microns) invisible to the naked eye and generated by a digital key of 128 bits. The varnish layer is also used to invisibly mark the packaging or labelling with micro thickness variations invisible to the naked eye and impossible to replicate. Existing production workflows in place for printing the non secured packaging is used “as is”, without extra production cost and without extra energy consumption.
These micro dots or micro thickness variations are integrated in the packaging or in the label design before printing with normal pre-press software and are invisible to the naked eye. They are very difficult to distinguish, even with a magnifying glass, as the dots’ colour and size are chosen to be camouflaged within the imperfections found in all printed material structures.
Fig 2: Examples of microscopic details of Cryptoglyph® invisible security patterns made in the varnish layer of a label (left) and on a face of an offset printed secondary package (right).
The detection of the presence (genuine) or the absence (fake) of these micro dots or micro thickness differences on a packaging or on a label is performed by software using specific techniques designed to detect information with low signal-to noise ratio and built-in redundancies.
Cryptoglyph® is the only security process in the world that provides invisible security marking with nothing more than regular visible ink and standard printing processes (offset, rotogravure, flexography, laser, inkjet, etc); the Cryptoglyph® can thus be easily integrated into any existing packaging or labelling production line, without alteration of the printing speed and without modification of the production workflow, namely without extra production cost.
Protecting the tablet itself
Protecting pharmaceutical packaging may not be enough. Solutions have been proposed based on embossing of the tablet or use of a chemical taggant; but such solutions require modification of the manufacturing process. In particular, the use of a security taggant requires proper management of this type of security feature. In addition, nothing would prevent counterfeiters from finding a way to replicate this marking, whether it is visible or invisible.
Recently a new patented solution was disclosed by AlpVision under the name of Fingerprint™ and based on the unique and intrinsic characteristics of the tooling used in the tablet presses. Therefore no additional marking is necessary. Just using the natural micro-imperfections of the punch die sets are enough and can serve as security features. The process only requires the storage of a digital image reference or “template” of each punch die set used to produce the tablets. It follows that only a limited number of templates are necessary to authenticate the whole production of tablets.
Fig. 3: Microscopic details of a punch die set used to produce tablets with a sample of tablets produced with the punch die set, all containing the “signature” of the punch die set and used as a security feature even coated.
The same Fingerprint™ process can also apply to identification of moulded plastic jars’ closures serving to contain powder or liquids as these closures are moulded parts which contain the replication of the unique identity of the mould cavity used to produce these closures.
Fig 4: Example of a plastic closure of a baby food jar which can be identified with a template reference of the mould cavity used to produce that part.
“Genuine-or-Fake” verification with regular off-the-shelf electronics equipment
Although covert security markings usually need specific scanners, the detection of the Cryptoglyph® covert security marking and the identification of genuine tablets or jars are software based and only require standard electronic devices such as office flatbed scanners or PDA’s (Personal Digital Assistant) equipped with a camera. The authentication is machine readable; it can therefore be performed anywhere anytime using a centralised and secured server via a Web application.
Fig 5: Example of online Genuine-or-Fake verifications using standard consumer electronics equipment and the AlpVision’s Krypsos™ Web application.
In conclusion
The combination of security features on packaging and labelling together with tablet and jar authentication allows a very high degree of protection against counterfeiting and has to be considered separately from serialization and track & trace features. Software and digital imaging technology serving to produce covert security features enables protection of pharmaceutical products against counterfeiting without extra production cost, nor degradation of the production speed, nor any visible impact on the packaging and labelling. Machine readable security features enable any authorised person to carry out instant online “Genuine-or-Fake” verifications worldwide, with almost no prior training nor any specific security knowledge.
About the author
Roland Meylan is the co-founder of AlpVision and today 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)”, Switzerland, as well as a postgraduate education in Business Administration from IMD Lausanne International Business School. Meylan started his career at the graphic division of Bobst SA, the leading supplier of equipment for the folding carton packaging and flexible materials industries. Meylan also worked in electronic communication over international data transmission networks, the forerunners of the Internet. Since then, Meylan has contributed to numerous business start-ups in value added mobile telecommunications services as well as in the digital imaging and visual communication domains.
AlpVision, headquartered in Switzerland, is a leading supplier of digital security printing solutions developed to combat counterfeiting and secure printed documents. Its clients include companies which count amongst the top 100 enterprises worldwide and which use the AlpVision proprietary Cryptoglyph® technology to protect already over a billion branded products and documents. For solid objects, AlpVision provides a Read-Only technology under the commercial name of Fingerprint™. It is based on microscopic imperfections which are generated by the manufacturing process used to produce an object and which are enough to identify and to trace any object during its entire life. 