Pill pack tracking

In 2004, the US FDA recommended the adoption of RFID to track all drugs at unit level by 2007. Two years later, the agency – regarded as the global authority on pharmaceutical regulatory matters – made a U-turn, admitting this prediction was “aggressive” and adoption was “unlikely to happen”.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) published its opinion last May, and arrived at pretty much the same conclusion – that while RFID is set to play a major role in the supply chain, the jury is out on when and how that will be. For now, the approach advocated by EFPIA is the inclusion of 2D Data Matrix codes on primary packs.

So what is thwarting uptake of RFID? On paper, the case at item level is compelling in a global industry where 1% of the drugs in circulation are thought to be counterfeit.

“The main benefit of RFID-tagging at item level is that you authenticate a drug against counterfeiting by proving its legitimacy through its electronic pedigree,” explains Osborne.

Coded identities
RFID tags have a unique identity code that is embedded in the microchip and may not be altered. Sato Labelling Solutions, which will be exhibiting at Interpack, explains that RFID systems are designed to operate at one of three frequencies: low (LF), high (HF) and ultra-high (UHF).

LF tags are used for small-scale applications in the retail sector, and have a read range of around 10cm. HF is more suitable for item tracking, with a read range of around one metre. UHF tags can be read from up to three metres away, and can transmit data much faster. However, mobile phones, Wi-Fi and Bluetooth all operate in the UHF range, making it a crowded frequency.

Unlike 2D technologies such as barcodes, RFID tags do not require line-of-sight to operate – they simply need to be within range of a reader to work, allowing contactless data transfer. RFID tags are either active or passive. A passive tag has no battery, operating by absorbing the energy from a reader and reflecting its encoding ID number back to that reader.

But while RFID is a concept the industry welcomes in theory, the reality is that few producers are choosing to tag each pack of drugs. Commercial implementation is virtually non-existent outside the US, where it is limited to niche applications such as AstraZeneca’s Diprivan anaesthetic, and drugs prone to counterfeiting, such as Pfizer’s Viagra.

“As we stand today, there are no mass adopters of RFID,” says Rob McGregor, business development manager at Toshiba. “There are lots of trials going on, but because the supply chain is so fragmented, building the required infrastructure is complex.”

One obstacle to adoption is, he says, that prospective buyers don’t know what they need to implement RFID, and where they can get it. It was this realisation that prompted Toshiba to launch its RFID@Toshiba programme last July.

“We looked at the marketplace and realised there was nobody offering an end-to-end solution,” he explains. “RFID@Toshiba offers pre-sales consultancy right through to after-sales service, ensuring the correct technology and systems are installed, standards are complied with, and all the right hardware, software and components are installed.”

RFID infrastructure
Cost is an oft-cited barrier to the adoption of RFID, both in terms of the tags themselves and the investment in an infrastructure that spans the entire supply chain.

“It’s a chicken-and-egg situation,” says Raghu Das, managing director of RFID consultancy IDTechEx. “People don’t want to invest in the infrastructure without enough drugs being tagged, but they won’t tag as they are not going to get the payback.”

So what is actually involved in implementing RFID? First, there’s the question of applying the tag to the pack. “If you want a very counterfeit-safe product you can embed the tag into the pack or bottle when it’s being made; the alternative is embedding the tag in a self-adhesive label,” says Das.

For printing, encoding, verifying and applying pressure-sensitive RFID smart labels, Weber produces the 5200rfid printer-applicator. As labels are printed, digital information is instantly encoded on to tags embedded in the smart label material.

Packaging specialist Rexam offers the ability to embed RFID tags directly into the packaging material. It converts the tags into encapsulated discs that are moulded into injection-blow-moulded containers. Domino offers similar technologies for corrugated board packaging.

“Embedded RFID centred in the base of containers allows higher read performance than label-applied solutions,” says Isabelle Delcroix, product manager with Rexam Pharma. “It also means there are fewer null reads from tag-to-tag contact – Rexam tags are always separated on conveyor lines and keep consistent orientation.”

In addition, users need the hardware component, namely the reader/writer, and an antenna. Rexam demonstrated the ability to read 48 bottles in a case, and read/write 500-600 bottles per minute on a conveyor at the 2006 National Association of Chain Drug Stores RFID Track & Trace Summit. “The investment is relatively low on the hardware side – readers are between £1,500 and £2,000,” says Delcroix.

Then there is the investment in software for transferring tag data to an organisation’s enterprise system. “The software, either as a package or customised, and the data management integration are expensive,” she adds.

The infrastructure doesn’t end with the manufacturer. Implementing RFID requires a redesign of the entire supply chain information infrastructure along ‘collaborationist’ lines, so each transaction is recorded and verified as the product moves from manufacture through logistics to the pharmacy.

“Trying to establish a system to maintain a continuous history of the chain of custody for tens of millions of pharmaceutical cartons will not happen because of the complexity of the supply chain,” says Osborne. “It’s a gigantic step – like trying to put a man on the moon – which is why, instead, people are trying to put a man into orbit.”

In other words, rather than trying to go the whole hog and introduce RFID at the unit-level, pharmaceutical manufacturers are preparing to take their lead from the FDA and EFPIA by including a 2D code on each unit.

Cost-effective
2D codes are more cost-effective and robust than RFID tags and can carry a serialised number, a Global Trade Item Number, a lot number and an expiry date. In addition, existing scanners found in most pharmacies can read 2D codes.

And according to Domino’s Integrated Systems (IS) Group, it is possible to build secure supply chains without RFID at unit level. The firm has implemented what it describes as the world’s first fully integrated track-and-trace solution for the pharmaceutical industry using 2D codes. The system uses electronic product codes embedded in 2D Data Matrix codes to track drugs administered to haemophilia patients at Dublin’s St James’s Hospital. The next step, it says, will be to introduce a hand-held web-based device such as a mobile phone, which can be used by patients to scan the code from the drug pack when taking the product. This will enable the patient’s records to be automatically updated and prevent manual errors in recording data.

Tony Walsh, European business development manager at Domino’s IS Group, believes ‘hybrid systems’ will become popular in the next few years. “At unit level, manufacturers will use Data Matrix to ensure all the data required for legal purposes is on the pack. Then at case and pallet level, I suspect there will be a hybrid system in which RFID is used in conjunction with Data Matrix coding,” he says.

“You don’t need the same solution at every level. RFID is proving to be extremely successful at case and pallet level, but at item level it is not turning out to be the carrier of choice.”

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FIVE-MINUTE INTERVIEW
Q How has pharmaceutical packaging equipment changed in the past five years?
A Machine outputs have increased enormously. Line speeds have at least doubled. At the same time flexibility has become even more important than output, as have automatic in-process controls (weight and functions).

Q What are the drivers behind these changes?
A Pharmaceutical companies traditionally focused on R&D to improve economic success. Today, more and more of the formulation, production, and packaging process is geared to reducing costs. The new biotech products have also brought additional demands. The tiniest product volumes often represent a lot of money, so every ‘drop’ has to be used and waste has to be reduced to virtually zero.

Q How have you updated your equipment to keep abreast of changes?
A CIP and SIP technologies are part of our offering, we have new servo-driven functions and the filling systems can be changed as products change. All of this has been developed to maximise flexibility. We offer turnkey lines with all up- and downstream equipment – including RABS (Restricted Access Barrier Systems), closed RABS, isolators and lyophilisation (freeze dryers). We are able to include our own MES (Manufacturing Execution Systems) and automatic quality control systems.

Q Will you be showing any new pharmaceutical packaging equipment at this year’s Interpack?
A We will present ourselves as a complete partner for pharmaceutical filling and packaging. This is the first Interpack where we are able to offer a ‘one-stop shop’ for filling and packaging, freeze drying and control processes. We will present a machine that can be equipped with a filling system and is capable of packaging 36,000 syringes per hour.

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