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Pharmaceutical Manufacturing and Packing Sourcer

Don’t Believe the Hype

Faced with increasing industry pressures, especially ever-stringent demands from regulatory bodies and the need to boost business performance following the global economic meltdown, a considerable number of companies operating within the pharmaceutical manufacturing and packaging sectors are searching for new ways to improve traceability, while streamlining many processes to boost profitability, in order to stay ahead in today’s competitive and challenging market.

This has led to more and more companies in the US, Germany, UK, France, Spain, Italy and Japan looking to RFID technologies in the hope of finding an effective way of storing and sharing data, as well as enhancing operational efficiency.Driven somewhat by the barrage of media attention following its high profile introduction, this still relatively new technology has come to the forefront of the automatic identification and data capture (Auto ID) market in recent years and has experienced notable growth in many sectors, including pharmaceuticals.

RFID Under the Microscope

The global market for RFID products and services in the pharmaceutical industry was valued at $112 million in 2008 and this figure is expected to grow to $884 million by 2015, at a compound annual growth rate of 34 per cent over the same period.However, while these figures may look impressive at first glance, market research suggests that RFID technology adoption in the pharmaceutical industry is still in its infancy, as some companies are still concerned about the high investment required to implement the system.

Some reports blame the budget restrictions that have come in as a result of the global recession and the subsequent cost cutting measures for low adoption rates of RFID solutions.This is hardly surprising when you consider that 60 per cent of the RFID market value represents the share of hardware such as tags, readers and printers; it becomes clear that a substantial amount of capital is required to invest in the technology. For example, the overall price of purchasing and implementing an RFID network is generally estimated to make the outlay for applying each tag up to eight times higher than is required for a barcode label containing the same level of information.

Equally, to realise the full potential of RFID technologies one should remember that it is merely one component of a businesswide process that needs to work in harmony with other systems, such as the IT infrastructure; it is not a plug-and-play solution. Not only will RFID need to be compatible with the equipment in your own facility, but it should work with all the equipment used throughout the supply chain as well.This is another area where RFID often comes unstuck as there is currently a lack of commonly agreed standards, and this limited interoperability between different standards, such as the ability for a single reader to read tags from multiple frequencies, is creating a major issue. For example, in the US and Japan different transmission frequencies are used,making it logistically complicated to adopt the system at a global level.

There are also a number of other challenges posed by RFID implementation in the pharmaceutical manufacturing and packaging sectors, restricting its universal growth even further. For example, the reliability of tags can be affected by various environmental conditions, such as humidity and even the proximity of metal surfaces.Current RFID tags cannot withstand extremes of temperature and so they require temperature resistant housings if they are to be used in warehouse or transport applications, adding yet more cost and complexity to the equation.

Above all, pharmaceutical organisations are still cautious about investing heavily in a technology that has yet to provide a clear, solid business case, particularly in large-scale, global operations. People are becoming aware of the dangers of focusing too much on this new breed of Auto ID technology so as not to lose sight of the main objective, which is to ensure traceability from the point of manufacture right to where a medicine reaches the consumer.

Benefits of Barcoding

It is just as important not to overlook the existing options, namely barcode technologies, otherwise it can be forgotten that these still provide a sophisticated means of meeting critical goals, and usually at lower costs.While RFID may be perceived as a highly practical option for some applications, it should not be viewed as a generic replacement for the current technology.

Barcodes were specifically introduced in the 1970s to improve data management and accessibility simply and quickly, while reducing costs, and they have since gained universal acceptance, being extensively used throughout industry and proving their worth along the way. With RFID tags being in the spotlight so much, it is now not always recognised that barcode systems can even offer far greater performance and functionality, with a traditional 1D barcode containing as much information as an electronic product code (EPC) RFID tag, for example.

As enhanced data accuracy is usually the single most common reason for implementing an Auto ID system in the pharmaceutical industry, with data management often forming the backbone of many operations, it is vital to ensure maximum accuracy, particularly as data entry errors can ultimately be catastrophic. Companies with integrated barcode systems are commonly achieving 99 per cent data accuracy, while statistics from the RFID Research Centre at the University of Arkansas place the current accuracy rate of RFID at roughly 65 per cent. Clearly, the numbers speak for themselves.

Read rates are just as important and barcodes offer an exceptionally low risk of failures, typically less than 0.1 per cent, as opposed to the 30 per cent or so RFID tags that will need to be reprinted due to read errors.This low read rate is mainly due to the non-line-of-sight scanning that enables RFID tags to be read at a distance, something which, ironically, is usually listed as an advantage of the technology. As a result, checks will need to be implemented to ensure all items are detected.

Equally, privacy is critical in the pharmaceutical industry so you need to consider whether one solution is more secure than the other. For example, a printed barcode does not reveal much information to an outsider, yet RFID tags can give away a lot more, without even being seen.This has fuelled much scepticism among consumers, leading them to believe that RFID is being used for a more covert reason. Barcodes, on the other hand, are universally trusted and accepted, with none of the privacy issues that relate to RFID tags.

 Recent Barcoding Advances

Although it has not dominated the headlines in the same way as RFID, barcoding technology has also been evolving with the latest advances offering significant benefits to both manufacturers and packers.The introduction of innovations, such as 2D matrix barcodes, PDF417, QR Code and Datamatrix has meant that barcodes can now hold many hundreds of characters of information over and above the capacity of the latest generation of EPC tags. In particular, these new barcodes allow complex information to be recorded and read throughout the supply chain, making them ideal for use in the pharmaceutical manufacturing and packaging industries.

Similarly, a new generation of GS1 DataBar codes are expanding the potential of the system still further, offering sophisticated traceability and product specific labelling capabilities. These barcodes can be printed on extremely small labels,making them ideal for small or irregularly shaped drug items and support global trade identification numbers (GTINs) for variable data such as batch number, expiration date, serial number, price, monetary value, size and weight.This in itself significantly reduces the potential for expired medicines reaching the consumer, eliminating the risk of the bad press and consumer complaints that are so often associated with such an incident.

Just as importantly, these new barcodes are helping pharmaceutical businesses to secure their distribution channels against one of the biggest threats in the industry – counterfeit drugs.While the lack of a global study means that the true extent of the problem is not really known, it is one of the fastest growing grey economies and the World Health Organization (WHO) estimates that fake drugs now account for 10 per cent of the market. No less than 46 cases of counterfeit medicines, which included everything from antibiotics and steroids, to hormones, analgesics and antihistamines,were reported to the WHO between January 1999 and October 2000 alone.With the danger of such products containing hazardous substances, this is one problem that can present a significant risk to consumers and, therefore, must be eliminated.

As well as the health risks for consumers, counterfeit medicines also have a significant bottom line impact on drug companies, costing an estimated $46 billion annually. Just as damaging is the loss of investor confidence and the consequent decline in share prices that can occur from counterfeiting incidents. By using barcodes to feed data back to the manufacturer, suppliers and retailers a closed-loop data system can be created that continually monitors the status of a product as it travels around the world, helping manufacturers prove the validity of a product or shipment quickly and simply. Ultimately, this increased degree of supply chain security is vital in helping the pharmaceutical industry to improve brand reputations in the delivery of safe drugs.

With so many benefits, these latest barcodes are set to become the industry standard for labelling the pharmaceutical sector and are already experiencing widespread acceptance in the UK, US,Denmark, Austria and Canada. Most recently, France adopted the Datamatrix system in line with new traceability regulations created by the French Agency for the Sanitary Safety of Healthcare Products (AFSSAPS) that came into effect in January 2011. As a result, any pharmaceutical company wishing to market their products in France will now be required to print a GS1 DataBar directly onto the secondary packaging to allow more complex tracking, as well as even more security codes to be embedded in barcodes on batches of drugs or healthcare products.

Conclusion

While RFID may parade itself as barcoding’s cooler, younger sister, media sensationalism and rhetoric count for little at times like this when budgets are tight and mistakes can mean the difference between sinking or swimming. For most companies, the proven benefits of a trusted, established technology, such as barcoding, are often favoured to provide security and assurance in the knowledge that the solution will deliver the increased level of control that is needed throughout the supply chain to guarantee the safety of patients, at the same time as protecting the manufacturers and improving the distribution of pharmaceuticals.




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Mark Beauchamp is European Marketing Manager for Citizen Systems Europe. With over 20 years of experience at the company and a wealth of technical knowledge, he is adept at helping channel partners and end-users alike to understand the latest printing technology. In addition to working with Citizen’s clients across Europe, the Middle East and Africa, Mark regularly visits the company’s head offices in Japan as a leading driver in product development. Mark was, until recently, Chairman of AIM UK, the British chapter of the Auto-ID manufacturers’ association. Email: mark@citizen-europe.com
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