By the numbers

15 April 2013



As well as the normal considerations that affect most packaging production, the pharmaceutical sector also has to cope with many and varied regulations, as Nessan Cleary reports


For obvious reasons the pharmaceutical industry is heavily regulated and much of this legislation has a direct impact on the packaging used in this sector, whether it's to combat counterfeiting or to ensure that patients have all the relevant information about the medicines they are taking.

Indeed, counterfeiting is one of the biggest issues facing the pharmaceutical sector, with the World Health Organisation estimating that up to 10% of the pharmaceuticals used around the globe could be counterfeit. Many countries have introduced their own legislation to deal with this issue and these often have different requirements from one market to the next, but the main feature is the use of serialisation to track drugs. This involves putting a unique identifier on each pack and should make it possible to trace the entire supply chain for any given pharmaceutical product.

The main regulation affecting the European market is the Falsified Medicines Directive (FMD), which was adopted in 2011 and is due to come into force in 2016. This has a number of requirements, as Craig Stobie, life sciences sector manager at Domino Printing Sciences, explains: "While every pharmaceutical pack has been required for many years to carry variable data in some form, the Directive is a significant shift, in that data will be unique to each pack rather than to each batch. Much of the coding equipment deployed today is simply not capable of serialisation, meaning that many manufacturers will need to implement a wholesale upgrade of their coding kit."

Line speed is also a key consideration, says Stobie. "With more data to be applied, there will be an inevitable impact on throughput," he says. "In essence, stakeholders will need to acknowledge that there is a trade-off between production targets and the rate of false rejects. The combination of low running speeds and high reject rates - at least in the early stages of implementation - is a 'perfect storm' in terms of operating efficiency."

Bart Vansteenkiste, EU lifesciences sector manager at Domino, says that as well as upgrading the printing and verification systems, many companies may struggle with the data requirements, as they will have to send potentially hundreds of thousands of unique codes to a centralised European database. This database is a key part of the scheme as it allows the main stakeholders to check the codes on the various products.

However, work has yet to begin on developing this. Vansteenkiste says that it will take a while for everyone in the production chain to put the appropriate systems in place. "People who are implementing serialisation now say that it takes a year to make this work, ", he adds. "And then you would probably want a pilot project to test it, so it could take two to three years to be fully compliant."

Hayden Waller, sales manager for inspection systems and track & trace provider Laetus UK, agrees that setting up the data management is the key issue, but points out that there are several systems the European model can learn from, including in Turkey, where serialisation codes are already in use, and France, which has a system that has room for expansion for full serialisation.

Laetus has a product, called Secure Track & Trace System (S-TTS), which takes a modular approach allowing customers to take the whole system or to integrate part of it into an existing set up.

Essentially, this provides a top level of control that can send the unique codes to the individual print units on each packaging line, and can then read those codes back from the camera units on those lines. This can track the individual items through the packaging lines as they are collected into bundles and batches. Waller says: "All the codes have to be 100% reconciled. If there's any uncertainty that a code is in the wrong place then there's a manual process to remove those bundles to clear the line."

Adherence
Another big issue facing pharmaceutical companies is that of patients failing to take the right medicines as prescribed, which can cause problems for patients and increases the cost of their treatment. One way to deal with this is to use smarter packaging solutions.

Dr Sue Miles, UK site director for specialist contract packer Anderson Brecon, explains: "A successful compliance package integrates a range of factors, such as innovative packaging design supported by a comprehensive manufacturing process. As the first point of contact for those taking prescriptions, aesthetically pleasing packaging can be highly effective. However, it is also vital that compliance packaging conforms to regulatory constraints concerning child safety, while also remaining appealing to older users."

A good example of this is a package that Anderson Brecon produced for Eli Lilly for its Strattera drug. The packaging played a crucial role in helping patients progress through a 30-day course of drugs, with the dosage changing every five days. There are different packs, with different dosages, depending on the weight of the patient. Anderson Brecon used a MWV Dosepak design, which features a large, fold-out panel, complete with graphics and colour coding for different days on a calendar, to ensure that patients are kept on track, taking the correct dosage each day.

Another simple solution to the problems of ensuring compliance is to use concise graphics to guide the patient to their dosing regime or to highlight opening instructions for child-resistant packaging techniques. But it can also include the introduction of RFID technology with the ability to monitor whether a patient has taken their medication and at what exact time.

Miles says that compliance packaging must be thought about carefully and adapted for each individual medication so it is able to meet the requirement of a range of different patients. She adds: "One of the key factors to success is having a complimentary team able to combine design expertise with knowledge of packing and manufacturing. The need for these combined abilities often results in collaborations of companies trying to share their knowledge in order to provide industry-leading adherence solutions."

Verification and proofreading
Another challenge is the need to prepare artwork and to ensure that the right version is the one that is carried through to production. Global Vision, for example, has tools that help prepare documents and artwork by comparing different versions. They can also check spelling against a dictionary of more than 30 different languages, mostly European, and against brand owners' phrases and brand names.

Peter Muller, vice president of business development for Global Vision in Europe, says there is a growing demand for inspection and proofreading technologies: "We find that pharmaceutical is becoming more interested about some of the tools out there, and they are integrating them more into their packaging workflows."

Muller also says there is a drive towards implementing standards and rules across the different parts of the supply chain so that different members of that supply chain can exchange files and materials. "Every department complies with its own regulatory requirements but does not necessarily transfer that information to the rest of the members of the chain." This could be something as simple as having everybody work in Microsoft Word or an XML spreadsheet.

The Global Vision systems are mainly used for checking samples after a production run and it's fairly common for most customers to use this approach in tandem with a verification system that can check the packaging during production. Muller points out that verification on its own isn't perfect: "They take a picture as a master reference image and then match each one coming through, but you have to be sure that you are using the right master image and that you have the right die. However they don't check the height of the dots and you can still have errors with that process because you don't have any control over how the machine gets set up. You could compare it back to the original artwork that was approved but you can't do 100% inspection of any packaging."

Braille is proving to be a particular problem. Muller points out that every country has its own form of Braille and there are different rules for packaging applications, and that it is impossible for most operators to read the Braille. He says there have been a number of packaging recalls down to mistakes with the Braille, noting: "One common error is that the operator puts the wrong die in the press."

Leaflets
Another area that is sometimes overlooked is that of the information leaflets that must accompany most medicines. GUK makes folding machines, primarily specialising in the pharmaceutical market, using complex folding patterns on very thin paper. Murray Lock, a director with GUK's UK distributor M-Partners, says that these leaflets have also been affected by legislation calling for larger text sizes to make the information more legible, which has led to larger-sized leaflets with more complex folds, which in turn has had a knock-on effect on the production speeds achievable on these lines.

But to some extent the pharmaceutical sector has always had to play catch-up on the various regulations. There are many new requirements coming, from the need for tamper-proof and compliance packaging through to the serialisation codes. This last will require investments in capital kit to handle the data and verifications systems, but it's a necessary step to protect the pharmaceutical industry, not to mention patients, from the dangers of counterfeit medicines.

www.andersonbrecon.com
www.domino-printing.com
www.globalvisioninc.com
www.guk-falzmaschinen.com
www.laetus.com
www.meadwestvaco.com




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