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Manufacture Small Molecules

Beyond Counterfeiting

When most people in the pharmaceutical industry consider serialization, they think about counterfeiting. But with a little outside-of-the-box thinking, track and trace has far more potential than simply deterring criminals. My company, Abdi Ibrahim (based in Turkey), began considering serialization back in 2009 – and since then, we’ve produced more than 826 million serialized boxes of medicine using 16 different packaging lines. But at the outset there were a number of concerns. Would implementing serialization lead to a drop in production efficiency or cause problems in cost and data management? Were there limitations with our current packaging lines or space limitations on our medicine packets? How would we integrate the serialization with our IT systems? All valid questions that we overcame – and we are now reaping the advantages. I’d like to share some of our experiences, in the hope that it may help other companies that are struggling to understand the benefits of serialization. Here, I’ll briefly explain how we rolled out the solution – and how we’ve learned that there are benefits beyond counterfeit prevention.

Implementing serialization is not as tricky as it might seem. Once we had decided to go for track and trace, the first step was to conduct a detailed facility analysis. We had to study the layout of our packaging lines to ensure that there was space for the new system on the line. And we had to check the dimensions of our packages and print designs – and then develop new designs with the appropriate space. It’s useful to focus your serialization project on three main steps: box transfer, printing and data management. The most important step is the box transfer – transferring the packets to the serialization system. We decided to go with a standalone unit with a box intake system – this seemed like the best option after reviewing our existing line – and it also ensured good transfer, high-print quality and minimum rejection rates. I urge anyone considering serialization to look at the same aspects too. It’s also beneficial to have a smart camera system that can read 2D code and carry out Optical Character Verification and Recognition checks, as well as software that can process the image correctly and minimize false rejects.

We also had to overcome the challenge of implementing the project without interrupting production.

We also had to overcome the challenge of implementing the project without interrupting production. This isn’t as difficult as you might think – we simply coordinated our project planning around our production schedules and other requirements. We arranged time for test boxes to be run on each line (an essential step – never forget to test your system!) and the results allowed us to optimize the mechanical solutions for optimum box transfer at each line.

We spent four months carrying out tests on the pilot line to check box transfer (all formats must be tested), print performance (must be checked at different temperatures and humidity), and print inspection (performance must be aligned with ISO 15415 norms). We also had to look at overall line performance to ensure it could cope with a real-size batch, and then there was data transfer. Data is essential in a track and trace system and you need to make sure that data flows smoothly from your line to the logistics warehouse, contract manufacturer, and so on. In addition, your server has to cope with multiple lines – we tested the server performance first at one line, then at three lines and finally at sixteen lines. The final step is an overall risk analysis.

All in all, it was a lot of time and effort. Was it worth it? Definitely!

Overall, the project took around 14 months and our reject rate is less than 0.3 percent (which is a relief given all of our concerns at the start of the project). All in all, it was a lot of time and effort. Was it worth it? Definitely! And once you’ve invested in serialization you’ll see that it doesn’t just deter counterfeiting. We’ve found that track and trace is also useful for other tasks like stock analysis – we can track amounts of our products both geographically and seasonally to help predict demand; for example, we’ll be able to see a sudden increase in product demand and be able to respond appropriately. The track and trace system will also likely be invaluable during a product recall and can help to prevent tax fraud since all products are registered and there will never be more than one sale for one box.

Serialization is inevitable given regulatory requirements, and setting up the right system for your business can take time and effort. But the sooner you get on board, you’ll realize that track and trace has potential well beyond keeping counterfeiters at bay.

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About the Author
Izzet Senol

Izzet Senol is maintenance and energy manager at Abdi İbrahim, Istanbul, Turkey.

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