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Pharmaceutical Manufacturing and Packing Sourcer

Coding Looks to the Future


In its early days, coding provided a fairly simple function in terms of expiry dates and basic product codes. As markets have become increasingly sophisticated, competition more intense and customers more demanding, coding has also responded with the introduction of more advanced technologies and equipment that can be tailored to precise requirements.

In more recent times, two factors in particular have had a major influence on pharmaceutical coding.There has been a growing need for full accountability in the supply of drugs and medicines. If a problem arises with any product, it is essential that everything can be traced back through the distribution chain and manufacturing process in order to pinpoint the exact cause. Effective coding can play an important role in this process and, in the worst-case scenarios, make product recalls easier to manage.

Linked to this is the increasing problem of counterfeiting.This has highlighted the need for the effective monitoring of products throughout the distribution and supply process and led to the development of today’s advanced track and trace systems.

Coding Until Now

Although these may be regarded as relatively new requirements, the need for more sophisticated coding dates back as far as 1994, when the US FDA implemented unit dose coding of pharmaceutical products using RSS (GS1 Databar) composite codes.This became the impetus for the development of the new generation of advanced coding equipment as the existing systems – such as debossing, inkjet and laser in existing packaging machinery – were unable to provide the necessary precision to print the new codes in a consistent and verifiable manner.

In 1996, new high resolution printing technologies began to emerge, capable of printing alpha numerics, barcodes and monochrome graphics, and which could print the RSS codes at the necessary resolution, with the ability to be read by automated vision systems.

Nevertheless, it soon became apparent that improving the print quality was only part of the total solution. Up until then, barcodes on packs for use at the point of sale were printed as part of the full pack graphics; under these printing conditions everything is fully controlled and the quality and readability of the barcode can be guaranteed. By comparison, adding pack coding to pharmaceutical packs was an add-on activity rather than an integral part of the process.This was not a problem for basic product information or expiry dates but inappropriate for more sophisticated coding requirements.

Therefore, in order to produce consistently readable codes with acceptable grades, a specialised product handling solution was required.This meant taking the responsibility for printing the variable information and codes out of machines such as cartoners and checkweighers, and installing an independent and dedicated printing station into the line, complete with high resolution printer, imaging system and fail-to-safety reject system.

New advanced coding systems have in turn helped to offer greater flexibility in the overall packaging process, for example recent initiatives such as late stage customisation,where standard packs are customised at the last minute with particular information for specific end markets.This helps to minimise origination costs, while enabling packs to be tailored to meet various legislative requirements in different countries,or allowing supply to be concentrated towards markets where demand is heaviest.





Several Options

With the array of specialist and high tech coding systems now available, choosing the right piece of equipment can be a daunting task. On the simplest of levels, companies will often be choosing between ink jet and laser technologies. However, within each technology there are further choices that can be made, for example between thermal inkjet (TIJ) and continuous inkjet (CIJ), or between CO2 laser and steered beam (scribing) lasers.

Before making any decisions it is vital that a company accurately assesses its requirements in terms of substrate, code content, line speed and factory environment, as well as the available budget. Future business needs should also be taken into account, ensuring that any coding and marking solution is able to meet the demands of tomorrow as well as today.

Laser offers high quality permanent codes without adding any additional substances to the product and can be as visible or discreet as required,with no drying time or risk of smudging. However, it is highly dependent on the nature of the material to be coded, as some materials cannot be marked by laser altogether and some are more difficult to mark, which can affect printing speeds.

Inkjet printing, on the other hand, is supremely versatile and can print on almost any substrate. It can print from one to multiple lines of text and simple graphics at high speeds, while a wide range of inks offering different colours, removable inks, fluorescent, colourchange and UV further adds to its appeal. A recent innovation has been the introduction of specialist inks that can now print directly onto foil blister packs, further enhancing the versatility of this technology.



Essential Requirements

The main driver today for pharmaceutical coding is the need for effective traceability and the resulting requirement for a coding format that can incorporate a huge amount of product and production information.This has led to the emergence of the 2D Datamatrix code format.

Interestingly it was the need for traceability in animal health products that first brought the potential of the 2D Datamatrix code to prominence. The Animal Health Medicines Identification Standard requires effective traceability for the possession, wholesale distribution and dispensing of veterinary medicinal products.These were previously met by paper records, but the International Federation for Animal Health (IFAH) recognised that 2D codes can provide greater flexibility and accuracy and are able to include a huge amount of information in a concise format.This means they also have the potential to be used on a worldwide basis, a vital consideration in markets where products are becoming increasingly global.

The 2D Datamatrix code can contain a greater amount of information than the conventional EAN 128 versions, which enables it to be more easily included onto primary packs or labels as well as outer cases. One thing to remember when specifying equipment to produce this code is that it does require a coding system with a print resolution of at least 600dpi.

While both pharmaceutical products and coding equipment have become more sophisticated over the years, inevitably so have the counterfeiters.Millions of counterfeit medicines are smuggled each year, and the World Health Organization (WHO) has estimated that 50 per cent of medicines purchased online are counterfeit.The WHO also believes that counterfeit medication accounts for up to one per cent of total consumption in developed countries, and up to 40 per cent in parts of Africa, Latin America and Asia, where regulatory and enforcement systems for medicines are weakest.

With this increase in supplies of counterfeit drugs through the internet and, more worryingly, also through traditional supply chains, the European Federation of Pharmaceutical Industries and Associations (EFPIA) lobbied the European Union to harmonise the supply of drugs in Europe by adopting the ECC200 standard GS1 Datamatrix. This is an international standard unlike the composite RSS code, and offers a true two-dimensional code with a high degree of error correction.



The European and Global Pictures

In 2009, the EFPIA ran a trial in Sweden linking manufacturers, wholesalers and pharmacists, which proved that a system based on tracking the product through the supply chain using a matrix code can be effective in anti-counterfeiting and ensuring patient safety.

There is less focus today on radio frequency identification (RFID) as a solution to track and trace requirements, although initially this was seen as the next breakthrough technology.While RFID does have many advantages, its high comparative cost, lack of standards and unaddressed privacy concerns mean that it is not yet thought suitable for track and trace in the pharmaceutical industry. However, any 2D system based on the GS1 standard should be capable of upgrading to RFID in the future once these issues have been addressed.

As with the animal health legislation, it is clear that a Europe-wide system at the very least – and ideally a global standard – will be of tremendous benefit in today’s international markets, particularly since several countries have already begun to ‘do their own thing’.

Turkey, for example,was the first country in Europe to implement track and trace in the pharmaceutical industry, and after a few false starts, the system became live in 2010. A 2D coding system has also been implemented in France with the CIP 13 coding requirement from January 2011. This is not strictly a track and trace system, but includes many of the elements that will be required in such a system. Most production lines serving the French market have been converted in advance, and are now proving valuable in determining the final requirement for full track and trace implementation.

The global picture is also quite fragmented. Brazil is currently deciding which way to move forward after rejecting a label-based track and trace solution, while the US with its e-pedigree requirement for California is moving slowly to implementation in 2015, and other states are also working toward this objective.

A common system of traceability is the sensible choice for tracking products around the world, and the EFPIA Swedish model seems the obvious way to go. There are financial justifications for this approach too. It is estimated that 25,000 packaging lines will need to be converted in pharmaceutical plants globally, at an estimated €150,000 per line, and this will cost the industry around €3-4 billion to put in place. Nevertheless, if each country has its own preferred system, this cost could increase substantially, rather than benefiting from the economies of scale from a common system.

In February 2011, the European Parliament approved the Falsified Medicines Directive by a large majority, which includes implementing a track and trace element into the manufacture and supply of prescription drugs throughout Europe. Once the final form of words has been agreed, manufacturers, wholesalers and pharmacists will be required to comply within two years.

Clearly this is a great opportunity for pharmaceutical companies to introduce comprehensive and effective worldwide anti-counterfeiting systems. Nevertheless, while the focus of these systems is on data collection and exchange, it is essential that the project is not regarded as primarily an IT issue. Ultimately, its future success will depend on the accuracy of the code printed on the pack – and if too little attention is paid to the engineering aspect, problems will continue to arise in the supply chains.

Pharmaceutical companies should therefore take great care in selecting the appropriate partner with the relevant experience. Installing a new coder is not as simple as merely placing it on the line and expecting it to work first time. Coders have to form part of a fully integrated system and are every bit as specialised as other processing and packaging equipment.



Conclusion

Coding will play a crucial role in helping to ensure the safe manufacture and distribution of pharmaceutical products across the world and effectively tackle the dangers of counterfeiting. Working with the right suppliers, pharmaceutical manufacturers will find these new systems will quickly prove to be a hugely valuable investment.



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Harry Thomason is Managing Director of the Travtec Group of Companies. After serving a fiveyear apprenticeship, he qualified as a mechanical engineer and trade union representative. His wide-ranging experience in a number of industry sectors has included production manager in an automotive chemical company and factory manager in a food business. He is also a director of Sunala Limited, distributor of Wolke Thermal Inkjet Printers, and a director of Nutec Systems Inc, a US based supplier of pharmaceutical track and trace systems. Email: info@travtec.co.uk
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