Implementation of the EU Falsified Medicines Directive requires various equipment and systems to be in place by 2018. Harry Thomason, MD, Travtec Group looks at systems with true vision that will help manufacturers with compliance
Key to the EU Clasified Medicines Directive (FMD) is the reliable traceability of any drug from manufacture to the end-user. Effective serialisation is essential to achieving this and this includes the need for a suitable vision system to allow the reading and verification of all pharma variant codes, including EAN, 1D and 2D.
This information is crucial to the entire distribution process, and to delivering secure data transactions required as part of the traceability system. It helps to ensure product security and patient safety – so it is critical that every pack that leaves a factory is correctly printed and the information it contains is easy to access.
While inaccurate or faulty printing may cause only minor inconvenience in most markets, in the pharmaceuticals and healthcare sector it could be a matter of life or death
However, it would be wrong to consider that compliance with the FMD is the only good reason for installing a vision system. It is just as important to demonstrate effective quality control as part of a company’s entire processing and packing operation. While inaccurate or faulty printing may cause only minor inconvenience in most markets, in the pharmaceuticals and healthcare sector it could be a matter of life or death. And any such errors can also have a huge impact on the manufacturer, namely the risk of litigation and the costs of recalling a product, not to mention the damage this can bring to a company’s or a brand’s reputation.
Although there are many coding systems now designed to prevent inaccurate input of information, where there is any sort of human contribution involved, there will always be the potential for human error. There is also the risk of the deliberate input of incorrect or misleading information. A vision system can ensure this is picked up before a pack leaves the factory.
Vision systems incorporate a digital camera to take an image of the printed data; special software is then used to compare this with the required image stored in the system. The equipment is particularly useful for non-human readable information such as bar codes and 2D data matrix codes, and it can also assess whether the code will be able to be scanned successfully or if there are any imperfections in the printed code: if the code is too light, or the lines too thick, or there are voids or spots, for example, that may inhibit successful reading.
As with most technologies, vision systems have continued to be developed and refined over the years. The most sophisticated examples available today are now able to offer a number of quality checks in addition to code accuracy. For example, character recognition software is available to read both pre-printed and in-line printing and automatically detect shift or rotation variations. Colour verification can also be monitored, as well as checking the accuracy of logos and artwork and the presence and position of labels, caps and other items.
Choosing the correct vision system can be a complex process, with many different factors needing to be taken into account
Choosing the correct vision system can be a complex process, with many different factors needing to be taken into account. The most important, naturally, is to consider the requirements of the particular production line. Speed will be a critical consideration to ensure that the system is able to cope with the line as a whole.
Ease of set-up for operators is another crucial area that can help to ensure the smooth and efficient running of the line. Rather than having long production runs of a single product, many companies are now moving to shorter runs and frequent changeovers, so making the process as fast and simple as possible can add valuable minutes to each run and reduce the risk of error.
Late Stage Customisation, where standard packs are customised later in the packing process with particular information for specific end markets, is also becoming increasingly widespread. The right vision system will be able to handle very easily the checking of different information on smaller batches of print.
The line speed issue will often depend on how the vision equipment is set up. If the system has to analyse all printed information in great depth, this can slow down the process significantly. Manufacturers therefore have to assess and agree what needs to be inspected and how closely. Clearly the content must be accurate, and any codes must be readable – but a small imperfection in a character, or a line that is not quite centred, neither of which would affect the ability to read and understand the data, might be acceptable. This will keep the number ‘false rejects’ to a minimum while still ensuring that no inaccurate printed information gets through.
A vision system allows the reading and verification of all pharma variant codes
A further consideration might be the footprint of any selected vision system. Very often these will need to fit into existing lines but even as part of a new project, factory space may be at a premium, so compact dimensions for the equipment will be important.
And this, of course, underlines perhaps the most critical factor in choosing a vision system – the equipment will not be operating in isolation but has to function as part of a complete production and packing line. So it will be vital that the system is able to integrate effectively not just with other equipment on the line but also with a company’s main ERP operating system, such as SAP.
Installing any piece of equipment is not as simple as merely placing it on the line and expecting it to work first time
However, integration is not only needed on an IT level. Just as important is the engineering aspect. Installing any piece of equipment is not as simple as merely placing it on the line and expecting it to work first time. Producing consistently high quality readable codes within acceptable grades requires the design and installation of a system that includes not only the right coder or labeller and vision system, but one that effectively links all these machines through specialised pack handling equipment and with an appropriate fail to safety reject system. Pharmaceutical companies should therefore take great care in selecting an appropriate partner with the relevant experience.
When installing any new line or piece of equipment it will also be essential to ensure they include a degree of future proofing so that the machines are able to meet changing and evolving market requirements. One of the most recent developments, for example, is the need for aggregation so that individual packs, which are then grouped into batches and subsequently placed in shipping cartons and then onto pallets, can still be accurately tracked and traced back to their original production.
While this level of traceability is not required as part of the FMD, it is increasingly being specified by other regulatory bodies for other markets and the incorporation of aggregation capabilities in current vision systems will therefore enable companies to trade easily worldwide in the coming years.
For example, California is working towards the introduction of an ‘E-pedigree’ for prescription drugs, which is taking effect on a staggered basis from February 2015. The new Electronic Product Code Information Services (EPCIS) for pedigree track and trace requires a record, in electronic form, containing information regarding each transaction that results in a change of ownership of a given drug – from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers or pharmacies, to the final sale to a pharmacy or other person furnishing, administering, or dispensing the drug. This has to be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution. Effective aggregation will be one element that will help manufacturers meet this new standard.
This highlights the fact that manufacturers need to think more widely and further ahead than just the requirements of the FMD. While the directive has focused minds on the need for serialisation and traceability, meeting its requirements will by no means be the end of the story.
Regulations and legislation in any industry are constantly changing and being updated or refined. Implementing them across more than one country only adds to the complexity. And of course, while the FMD covers the European Union, today’s global market means that companies have to be aware of more than one set of regulations and adapt their systems and procedures accordingly.
Companies currently seeking to invest in vision equipment to meet the FMD should think very carefully not only about their immediate requirements but also what they may need – and where they may be supplying – in the future
If the Californian model is an indication of what could become a more worldwide standardised requirement in the coming years, companies currently seeking to invest in vision equipment to meet the FMD should think very carefully not only about their immediate requirements but also what they may need – and where they may be supplying – in the future.
And as part of this future-proofing, pharmaceutical manufacturers need to ensure that they have the flexibility and freedom to continue to choose the appropriate equipment that is right for their business. The focus on the need for integration means many suppliers are now offering ‘complete’ solutions comprising not just the various pieces of equipment but also the software systems and packages that allow them to work together. This may be a very tempting offer at first glance but there is a danger of companies then being ‘tied’ to one particular manufacturer or system and this can have a detrimental effect as markets develop and business focus and requirements change.
To summarise, pharmaceutical manufacturers need to select a vision system that meets their practical requirements in terms of speed, design and levels of monitoring, while also having the necessary software to enable it to integrate effectively with all parts of a company’s operation. It is vital that the system has the appropriate level of future proofing but this has to come with an element of independence, so that companies are not tied in with a supplier who is not able to meet their longer term needs.
All of which means companies must choose carefully – not just the equipment but also a collaborative partner who can offer the appropriate advice and guidance every step of the way.