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Pharmaceutical Manufacturing and Packing Sourcer

Print Ready

The Falsified Medicines Directive (FMD) – implemented in 2011 – aims to reduce the number of counterfeit medicines infiltrating the legal pharmaceutical supply chain within Europe. From January 2016 onwards, manufacturers failing to comply with the directive will have to withdraw their products from the European market.

A core requirement of the legislation is the serialisation of individual pharmaceutical packs via unique codes encrypted in machine-readable, two-dimensional (2D) data matrix codes. Besides a randomised unique serial number, the data matrix codes are required to carry a manufacturer product code, expiry date and batch number. This increases the burden on manufacturers, as they must print and verify complex data matrix codes on cartons at high speeds – which is both costly and complex.

The majority of pharma manufacturers will have to upgrade their production lines to accommodate the sophisticated coding and image recognition systems that are capable of working at high speeds. Furthermore, it will not just be old embossing kits and hot foil coders that will need to be updated; we estimate that 80% of the coding solutions currently used in pharmaceuticals and healthcare will be rendered obsolete by the FMD.

Retrofitting a coding station that can transport the filled carton, print and inspect the code, as well as reject inferior packs, is problematic on lines where space is at a premium – posing the challenge of integrating different interfaces and avoiding any compromise in line efficiency.

Falling Short

While, in theory, most modern inline coders are capable of reliably producing readable 2D codes, in reality this is not always the case. Manufacturers typically find that continuous inkjet (CIJ) printers are not up to the task because they struggle to consistently produce 2D codes that meet the International Organization for Standardization/International Electrotechnical Commission 15415 quality specification.

Code quality is crucial for machine-readable codes. Under the FMD, 2D codes must be verified via a camera-based system to confirm that the unique, encrypted number has been printed on the pack. Vision system performance is influenced by the quality of the code, and 2D codes that are slightly fuzzy, blurred or out of position might be unreadable. Therefore, rejection and reworking of any packs carrying unreadable codes will have serious implications for overall equipment effectiveness (OEE).

However, there are other reasons against using CIJ for pharmaceutical coding besides its relatively low print resolution: the technology is perceived as messy and dirty, with a high risk of ink spillage and odours emitted by the solvents used.

An alternative relies on thermal inkjet (TIJ) printers, which place their pixels more accurately and offer higher resolution printing – typically 300dpi or above – compared with CIJ systems. This makes TIJ appear the obvious print technology of choice for pharmaceutical 2D codes.

Perfect Presentation

But even where manufacturers are using TIJ, print quality is still dependent on the feeding of the carton into the printer. Data matrix barcoding requires near-perfect presentation of a carton in order to achieve the highest verification grade – this means cartons must be fed smoothly, flat and square to the printer. Any deviation from this may cause a serious flaw in the print, resulting in miscoded packs that cannot be validated by an online vision system.

Recurrent miscodes can lead to major production inefficiencies.

Consequently, accurate carton feeding is crucial and, with an online system, the necessary precision will rarely be achieved without the addition of an extra line element to control the carton during print and inspection. This can have serious space implications and revalidation issues.

Moreover, pharmaceutical cartons are usually coded on the end fl ap. Further potential for miscodes arises when the closed end flap bulges, presenting a convex surface to the printer.

Maintaining Speed

Producing high-quality serialised codes at the line speeds required by some pharmaceutical operations is not easy either. Current systems generally print the same information around 20,000 times. With serialisation, however, companies are printing 20,000 batches at rates of up to eight per second.

Manufacturers have to get all those numbers to the printer: filed, printed and never duplicated. Therefore, the key is getting data into the printer and making sure print speed is high, so factors like drying time become very important.

The essential requirement for codes to be verified immediately after printing may also impact line efficiency. The vision system needs enough time to acquire an image of the 2D code and the human-readable lines of text to process the information, and then must come back with a decision as to whether the pack is acceptable, all before the next pack is positioned in front of the camera. Both the printing of serialised codes and the code verification step could slow down the movement of the production line.

Moving Offline

For many pharmaceutical operations, the answer to these issues could lie in taking coding offline with a modular system that incorporates printing, labelling, inspection and automatic stack-to-stack feeding technology.

Offline overprinting systems are particularly useful where a large amount of text is necessary or the print is required to meet an exacting standard – such as the 2D data matrix code on a pharmaceutical carton. By taking this process offline, the cartons are brought to the line ready-printed and inspected, eliminating any delays due to coding issues. The potential for rejects is massively reduced because the carton can be presented to the printer in the most favourable orientation. For example, an offline system will print cartons flat, avoiding any potential problems with miscodes on bulging end flaps.

Gravity also works in favour of offline printing. Whereas an online printer usually sits adjacent to the line and applies the ink across the pack, an offline system’s nozzles fire the ink from above, minimising the risk of run from excess ink and producing clear, crisp codes.

Many companies assume that an online system will be faster and more efficient than an offline one; but, after taking into account the impact that inline verification, serialised code printing and miscodes could have on line efficiency and OEE, offline coding starts to look like an attractive option. Speeds of up to 200 packs per minute are well within the capabilities of an offline coder, and a range of pharmaceutical packaging formats can be coded offline, including cartons, wallets, crash-lock cartons and sleeves. In fact, small batches of only a few hundred cartons or even less are more efficient and economical when coded offline. Systems can be positioned either near or next to a line to keep it supplied during running, or they can supply a second line in a central location.

Cost of Compliance

From an investment point of view, the cost of complying with FMD through an offline system is far lower than the cost of upgrading an online system, particularly after considering any disruption and downtime. It can take several months to decide on an equipment supplier, then up to a year to set up and test a new line. In contrast, an offline system is independent of the production line and can be up and running in a matter of weeks.

Offline coders can be built with an inline diverter flap reject system for automatic removal of cast-off cartons, software controls and shingling (accumulation) conveyors to maintain high throughput. Integral inspection of the printed information and pharmacode verifies that data matrix codes and human-readable information, such as expiry dates and lot codes, are correct.

Additionally, offline systems can be fitted with either a TIJ or thermal transfer printer, depending on the application. In some scenarios, a system incorporating both technologies may be configured. For example, manufacturers may want TIJ for printing on the flap of a carton – which is a rough, varnish-free surface – and thermal transfer for coding the main body of the pack – which is a smooth, glossy surface.

Alternative Option

It is not just small, low-volume producers and packers that are embracing offline coding. Multinational pharmaceutical manufacturers are increasingly realising that it offers a way of complying with new legislation without impacting the production line.

The timetable for FMD implementation is tight, but instead of rushing into expensive upgrades to production lines, pharmaceutical manufacturers and packers would be well-advised to consider offline, as well as online, options. With the FMD, coding has become a core capability – without it you cannot manufacture – so there is no margin for error.

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Richard Pether is Director at Rotech. He has worked with a variety of coding technologies, as well as other packaging machinery within the pharma industry, and has particular knowledge of TIJ technology and its use in data matrix barcoding. Currently, Richard is responsible for managing the control system on the feeder range, allowing for an array of additional functions to be incorporated and varied equipment to be integrated. He has a degree in Mechanical Engineering and started his career at Allen Coding GmbH.
Richard Pether
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