Closing the gap on pharmaceutical counterfeiting

Kevin Heap, packaging expert at Sumitomo (SHI) Demag UK, explains how specialist medical and pharmaceutical closure moulders are using the latest injection moulding precision techniques to keep one step ahead of counterfeiters to protect trademarked brand integrity.

Pharmaceutical safety demands traceability. Yet, even with stringent serialisation standards and covert technologies like barcodes, holograms, sealing tapes, and radio frequency identification devices to preserve the integrity of the pharmaceutical products, counterfeiting remains a multi-billion pound industry.

However, thanks to new security measures, including anti-refill and tamper evidence caps, many of which are designed using complex injection moulding techniques in the UK, pharma companies are fighting back against these illicit networks.

The cost of fakes

Fake medicines cost the EU pharmaceutical sector €10.2 billion each year. In July 2016, the European Union Intellectual Property Office (EUIPO) reported that €605 million, or 3.3 percent of the UK pharmaceutical sector’s sales, is now lost annually as a result of counterfeiting, with 2,940 direct jobs lost. And task forces are finding more fake drugs every year.

Incorporating security solutions in product packaging is becoming an important anti-counterfeiting measure. One way to counteract fake medicines and product tampering is through the innovative design of packaging that cannot be easily copied.

Until recently, this may have involved having a simple tab on the cap which is broken once opened, or developing blister or strip packs and breakable caps that cannot be resealed. However, pharma cap moulders are stepping up the anti and investing in dedicated cells to produce high quality closures made up of a number of complex parts.

Keeping it senior friendly

However, the challenge for cap moulders supplying this sector is balancing protection of consumers with usability. As well as child resistance (CR) closures, pharmaceutical companies need to provide for senior friendliness.

Consequently, we are increasingly seeing moulders utilise sophisticated valve technology within the cap, as these can control the dispensing of product, while also preventing containers being refilled. Along with dosage control, these remain some of the key influences for cap moulders, and many new CR packaging concepts utilise complex and sophisticated opening mechanisms, such as blister packs that requires pressure being applied to two points.

Other recent examples involve developing a two-piece combination tamper evident closure for pharmaceutical syrups. Also popular are flip caps that can be locked or feature tear off bands. But, with just two years until the Falsified Medicines Directive (FMD) comes into force in the UK, some pharma cap moulders are being inspired by major breakthroughs in the alcohol and spirit cap market.

A spirited approach

One of the most innovative examples in the spirit sector is a cap that comprises 14 plastic parts, and features a non-refillable valve and a tamper evidence mechanism that provides an irreversible opening event to leave permanent evidence of initial opening. The cap is produced in high volumes and is modular by design, so that trade customers can adapt it to different brands and applications.

This cap works by releasing a plastic part when each bottle is opened. It is impossible to reinsert this part back into the cap’s neck and when it drops down it reveals a highlighted ring to indicate that the bottle has been opened. The producer of this closure is using five Sumitomo (SHI) Demag all-electric IntElect Smart 220 tonne and 450 tonne machines fitted with the company’s activeFlowBalance technology.

With 14 plastic parts, assembly of this cap is highly complex. Because each plastic element is small and needs to fit together to form the overall tamper evident mechanism, part quality is paramount. The injection moulding machines produce the plastic component, which is then assembled into the cap’s aluminium sleeve by downstream automation lines.

Alternative deterrents

Other overt packaging methods to deter counterfeits include concealing unique identifiers, such as a QR code or holograms, on the inside of cap labels. While these can assist with track and tracing, they only really help to validate the origin of a bottle. To outsmart quick-witted counterfeiters, pharma manufacturers may need to deploy several tactics simultaneously to prevent brand value being diluted, including tamper evident caps with holographic labels.

Use of infrared and ultraviolet (UV) light, microscopic tagging, molecular markers and biological tracers are also being deployed. These technologies can only be identified by customs agencies and authorised distributors using laboratory equipment.

For trade moulders producing pharmaceutical caps and closures by the millions, cost effectiveness is vital. It therefore makes good economic sense to build a complete moulding system to take care of all the anticipated applications, rather than trying to adapt existing equipment. Due to the increased precision involved in moulding caps, many manufacturers today are prepared to invest.