Pharmaceutical safety demands traceability
Yet, even with stringent serialisation standards and covert technologies such as barcodes, holograms, sealing tapes and radio frequency identification devices to preserve the integrity of the pharmaceutical products, counterfeiting remains a multibillion dollar industry.
However, thanks to new security measures, including antirefill 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.
Kevin Heap, packaging expert at Sumitomo (SHI) Demag UK, explains how specialist closure moulders are using the latest injection moulding precision techniques to keep one step ahead of the creative counterfeiters to protect trademarked brand integrity.
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% of the UK pharmaceutical sector’s sales, is now lost annually as a result of counterfeiting, with 2940 direct jobs lost. And task forces are finding more fake drugs every year.
As testimony, Interpol’s flagship pharmaceutical investigation, Operation Pangea seized 2.4 million fake and illicit pills in 2011. By 2015, the number seized by officials had spiraled to 20.7 million, double what was confiscated by the global operation 2 years previously.
Among the fake pills being sold to the public were diet tablets and controlled pharmacy pills such as diazepam, anabolic steroids and erectile dysfunction pills. But despite these successes, pharma fraud is getting ever-more prolific.
Incorporating security solutions in product packaging is becoming an important anticounterfeiting measure. “One way to counteract fake medicines and product tampering is through the innovative design of packaging that cannot be easily copied,” highlights Kevin.
“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 ante and investing in dedicated cells to produce high quality closures made up of a number of complex parts.”
However, the challenge for cap moulders supplying this sector is balancing protection of consumers with usability. Kevin explains: “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 2 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.
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. For production, Sumitomo (SHI) Demag supplied five all-electric IntElect Smart 220 ton and 450 ton machines, all fitted with the company’s award-winning activeFlowBalance technology.
Emphasising that repeatable moulding precision is crucial to the performance of each cap’s internal mechanism, Kevin says: “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."
"This is where activeFlowBalance helps, by ensuring even filling of the mould, precise shot weights and consequently fewer defects.” Sumitomo (SHI) Demag IntElect machines mould the plastic component, which are then assembled into the cap’s aluminium sleeve by downstream automation lines.
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, Kevin claims that 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, claims Kevin. 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.
“Owing to the increased precision involved in moulding caps, many manufacturers today are prepared to invest in new high-performance plant and switch from hydraulic and hybrid to all-electric injection moulding systems,” concludes Kevin.