Securing markets

3 May 2012



From anti-counterfeit cartons to high-barrier medical plastics, technical and materials innovation is taking pharmaceutical packaging into new areas with higher-value options. Paul Gander uncovers some prime examples in the sector


It might seem odd to associate the neo-conservative Donald Rumsfeld – or any other politician, for that matter – with the idea of criminal counterfeiting. But there is a link. Ten years ago, the then US Secretary of Defense made his famous remark about “known knowns”, “known unknowns” and “unknown unknowns”. Similar distinctions, it could be argued, can be drawn in the world of anti-counterfeit packaging (ACP) for pharmaceuticals, where return-on-investment can be a very thorny topic.

After all, while the sums invested will be known, tangible and sometimes considerable, the benefits may be unknown and intangible. In many cases, success would need to be measured in terms of the deterrent effect of the technologies in question.

So says Doug Moyer of Michigan State University (MSU), where he is a researcher with the Anti-Counterfeiting and Product Protection Program (A-CAPPP) in the School of Criminal Justice.

The level of threat, of course, varies from drug to drug. There is also huge geographical variation. Andrew Gilbert, business development director at security technology company Ingenia, quotes World Health Organisation (WHO) figures which put the proportion of counterfeit drugs in the developed world at around 1% of the total. “This may be a relatively small percentage, but it still represents a huge quantity of product,” he points out.

On the other hand, the equivalent WHO figure for the developing world is a massive 33%, he reports.

‘Unknown unknowns’ could also be taken to mean those threats from counterfeiting capabilities that can only be guessed at. Holograms, which were once thought of as a failsafe anti-counterfeit feature, are no longer proprietary, and do not offer the level of exclusivity or authenticity that they once did.

False assurance

The risk, says Moyer, is that so-called packaging ‘solutions’ can deliver false reassurance to consumers, and even provide camouflage for fraudsters rather than certainty for brand owners. He points to the example of counterfeit anti-malarial drugs used in south-east Asia, where the quality of the on-pack holograms was superior to those on the authentic product.

At cartonboard specialist Chesapeake Pharmaceutical Packaging, design manager Gill Wright points to other paradoxes of the international trade in counterfeit drugs. “We have seen examples of counterfeit product featuring an added hologram in which the original pack had no hologram at all,” she says.

The same questions have to be asked about more contemporary fixes such as 2D matrix-type codes. “It’s an attractive proposition to include a code which engages the consumer as a potential product authenticator,” says Moyer at MSU. But these codes can be readily copied or created and can inspire misplaced confidence in consumer and brand owner alike. “You have to ask whether a code of this sort is addressing an existing risk or helping to create a new one.”

But according to Wright at Chesapeake, this type of direct involvement of the consumer or patient is becoming more widespread. “Pharma companies used not to tell the public about specific features, and that is often still the case,” she says. “But manufacturers such as Pfizer are increasingly using websites to spread information about security labels, taggants in its inks, and so on.”

This, she explains, is a strategy largely borrowed from the luxury goods sector.

Chesapeake offers its own proprietary Pro-tex system of serial coding – the code’s authenticity, therefore that of the product, can be checked via a mobile phone.

In fact, as Moyer at MSU points out, there is a plethora of ACP features available. “These range from colour-shifting and thermochromic inks to security threads and chemical identification. Any given pack can incorporate multi-layered and overlapping features.”

This multilayering might span overt features that are readily accessible to the consumer, covert features which can only be checked by authorised individuals, and forensic features which are designed for laboratory verification, he explains.

According to Wright at Chesapeake, manufacturers will tend to put the simpler type of feature, at little or no additional cost, on to all of their packs. These options, which can vary from errors in microtext to the use of UV-fluorescing inks, will be more for covert oversight of markets.

Costlier and more overt features, such as variable and verifiable coding, might be reserved for those higher-value or other items such as HIV drugs where there is a known counterfeiting problem.

Scratching the surface

Gilbert at Ingenia underlines the fact that there is no standardised tracking system for drugs in either the US or Europe. “In Europe, for instance, there is no cross-EU regulation in this area.

There’s general recognition that something needs to be put in place, but the wheels turn slowly,” he says.

This state of affairs could be seen to benefit technology companies such as Ingenia, which offers a system that in fact adds nothing to the pack. Instead, the company uses laser surface identification to capture a trackable signature – or ‘item biometric’ – which is specific to each pack. This signature can then be checked at a later stage anywhere in the supply chain.

“This also addresses the issue of product diversion,” says Gilbert. “This is where pharmaceuticals are sold in certain countries at very low cost, but surface again in Europe, for instance, being sold for much higher prices.” The technology has been taken up by a range of companies, he adds, including some in the pharmaceutical and medical sector.

Bumpy road

One area where EU regulation has had more of an impact on pharmaceutical packaging is in the introduction of standards for labelling requirements. Here, one question which has been standardised more recently is the use of Braille.

“We have been incorporating Braille into our carton designs for the past 20 years or so,” says Wright at Chesapeake. “But before the CEN committee came up with guidelines, each EU Member State followed its own Braille specification, which included differing heights in countries such as France and Italy.”

In fact, says Wright, while this makes it easier for companies supplying across Europe, the more general challenges associated with Braille remain unchanged. “Pharma packs tend to be quite small, and into that small area you are required to fit the brand name, the generic name, dosage and – where more than one is available – the method of administration,” she says.

Chesapeake says it is among those board converters to have changed the way they apply Braille in order to be able to start and finish much closer to the carton crease. “Nonetheless, it remains a massive challenge, in many cases,” says Wright.

Compliance and safety

Much of the packaging innovation that has taken place over recent years in the pharmaceuticals sector has been driven by two issues: patient compliance and child safety. These two priorities come together in the different types of wallet-style pack that are now available, particularly those targeting the over-the-counter (OTC) market.

The idea is that, as well as providing convenience, they ensure that product and patient information stay together. They also put two or more layers of packaging between the product and any little fingers which might be eager to explore them further.

Of these designs, Burgopack has probably enjoyed the highest profile in Europe. Chesapeake supplies sleeves for the pack to UK license holder Brecon Pharmaceuticals.

Says Wright: “Initially, the novel format seems to drive sales. You’ll see people in airports, for instance, buying the product because of the pack. But after a while, the novelty wears off, and the consumer tends to buy the same product in a cheaper format.”

The child safety aspect has been largely driven by US guidelines, says Wright, which set down a minimum number of actions required before a blister can be accessed.

Of course, plastics are providing just as much of the innovation in pharmaceuticals packaging as paper and board. Veteran tube manufacturer Neopac, based in Switzerland, has based the majority of its business on the 12 lines producing around 60 million Polyfoil tubes annually, about 200m of which are destined for pharmaceutical applications.

The standard Polyfoil structure combining an alufoil layer with a laminate containing polyethylene has been diversified in order to offer optional structures based on polyethylene terephthalate (PET) and – particularly where heat treatment is required – polypropylene (PP).

Now, Neopac has ventured into an altogether new area, creating the Fleximed range of transparent, flexible tubes for medical applications. “They can replace ampoules or vials for parenterals,” says head of pharmaceuticals sales & marketing Martina Christiansen. “They are very different from blow-fill-seal alternatives, since they offer a high oxygen barrier.”

This barrier comes courtesy of a double layer of silicon oxide (SiOx) either side of a PET core. Finally, there is a twin layer of PP on each surface. “You can’t compare the resulting barrier with glass, but the double SiOx layer means it is the equivalent of – or better than – cyclic olefin copolymer,” says business development manager for medical packaging Christa Brandt.

Variants include the Fleximed Luerlock, which eliminates the need for syringes when dispensing product into a catheter or IV bag, and Fleximed Vial, which can simplify injections.

“There is clearly a safety issue with glass,” says Brandt. “But we see the biggest advantage in ease of use, and the fact that you can reduce the number of steps that have to be gone through.”

Finally, Fleximed Easymix can keep two substances separate until they are required. “This is for medication that might not remain stable when ready-mixed,” says Christiansen, adding: “It’s unique in the world market.”

In the end, any design which can successfully increase both security and convenience, whether in ACP, OTC patient compliance or medical packaging, is likely to be given a warm welcome by the pharmaceuticals industry.


Chesapeake’s Pro-Tex system provides an alphanumeric code that can be checked by phone Pro-Tex With its LSA technolgy, Ingenia captures an individual pack’s surface ‘DNA’ LSA technolgy Brand protection, by Ingenia Technolgy’s Laser Surface Authentication (LSA) Brand protection Chesapeake has changed the way it applies Braille Braille Scale filling at the Neopac laboratory Neopac

Pro-Tex Pro-Tex
LSA technolgy LSA technolgy
Braille Braille
Brand protection Brand protection
Neopac Neopac


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