Why complete product traceability is a must for modern business

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The 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 the global society.

Further, the pharmaceutical companies which have invested considerable sums in designing and patenting their medicines, are being seriously undermined by counterfeiters. Their reputations are tarnished whenever there’s an adverse outcome from an unscrupulous operator.

So the motivation to combat the illegal medicine trade is very high. Counterfeiting is even pervading into other industries, like medical devices, tobacco and food & beverage – all of which have encountered similar issues in 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 easily be 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 bank notes – 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 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 serialization system. This includes:

  • Lack of standards in relation to serial codes and how/where they can be printed. This is currently being worked on by the various standards organisations. The OPC Foundation has produced Open SCS and Omron is on the committee for this standard.
  • Managing the considerable data generated, given that each items will have multiple vendors and collection points. This will require several databases and much activity between them.
  • Implementing serialization on current manufacturing systems, which have been certified for their particular industry.

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 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. Data is more flexible and can be easily tailored by the various parties.

Omron, a global leader in automation and vision sensor technology, can offer both systems.

Omron’s FH visual inspection systems are capable of reading many bar codes at high speed, as well as OCR (Optical Character Recognition).

It also supports a vast array of visual inspection functions to ensure the quality of the final output. The controllers are able to support up to eight cameras and can be connected to automation controllers via the EtherCat network.

This technology provides a giant leap forward in combatting 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 for Omron Electronics Oceania. He has been involved in the industrial control industry for 30 years – the last 25 years at OMRON Electronics.