OPINION COMPLETE TRACEABILITY IS A MUST FOR MODERN BUSINESS
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he counterfeit medicine market internationally is worth some US$32 billion and causes about one million deaths each year. This is a huge cost to the general health and wellbeing of society worldwide. Further, the pharmaceutical companies that have invested considerable sums in designing and patenting their medicines are being seriously undermined by counterfeiters. Their reputations are tarnished whenever there is an adverse outcome from an unscrupulous operator. So the motivation to combat the illegal medicine trade is very high. Counterfeiting is also becoming prevalent in other industries, like medical devices, tobacco and food and beverage — all of which have encountered similar issues to varying degrees. Traditionally, batch and lot numbers were used to find the source of faulty products. However, these could not accurately determine the root causes of defects in production. They also provided no real assistance in preventing counterfeiting, as lot and batch numbers could be easily duplicated. Serialisation is the allocation of a unique serial number to each item of production. The serial number is printed on both the packaging and as near to the actual item as possible. Serialisation allows traceability, which is the tracking of individual items through the entire supply chain. As every single item produced will have a serial number, the details of when and where it was manufactured can be confirmed by merely querying a database. A system of serialisation has been in place for many years in the production of banknotes — each of which has a unique serial number clearly printed on it. While counterfeiters may still attempt to produce their own legal tender, the presence of a serial number presents an immediate hurdle for them, as it helps authorities in their tracking process. Serialisation validates both the product itself and legitimises the supply channels. Pharmaceutical and food industries face a number of challenges in implementing an effective serialisation system, however. Firstly, there is a lack of standards in relation to serial codes
and how or where they can be printed. This is currently being worked on by the various standards organisations. The OPC Foundation has produced the Open SCS standard for example. There is also a challenge in relation to managing the considerable data generated, given that each item will have multiple vendors and collection points. This will require several databases and much activity between them. Implementing serialisation on current manufacturing systems, which have been certified for their particular industry, is also a challenge. Two possible solutions have been recently proposed for tracking and tracing. The single-system point-to-point solution — where there is a single supplier only and data is closed off — is the simplest solution, and in many cases ready to implement. Alternatively, the flexible layer solution — where production is separated from the data — is an open solution. While it is more complex and will require additional implementation, it provides a number of clear advantages, in that data is more flexible and can be easily tailored by the various parties. With the technology available today, both systems can be supported. Current technologies in visual inspection are capable of
18 WHAT'S NEW IN PROCESS TECHNOLOGY - OCTOBER 2016
reading many barcodes at high speed, as well as performing optical character recognition (OCR) in the same sensor. A vast array of visual inspection functions are supported to ensure the quality of the final output. Controllers are available that are capable of supporting up to eight cameras and can be connected to automation controllers via modern digital technologies such as EtherCat. This technology provides a giant leap forward in combating the counterfeit medicine trade. Most importantly, it will help to restore consumer confidence. Consumers can be assured they are receiving the genuine medication for which they have paid.
Harry Mulder is Engineering Manager at Omron Electronics Oceania and has been involved in the industrial control industry for almost 30 years. With a degree in computer science, his experience includes sales, engineering and product management. He currently manages engineering and marketing teams but still enjoys getting involved with day-to-day problem-solving.
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