Mar 10, 2006This article was originally published by RFID Update.
March 10, 2006—The application of RFID tags to cases and pallets has been, it's generally agreed, a major step forward in tracking and tracing products through the supply chain. It appears to have bridged the logistical 'black hole' between the manufacturing distribution department and the retail point-of-sale or administration/dispensing areas, and to have made possible a number of the 'missing' inventory and tracking processes.
Now, industry is waiting for the next 'Holy Grail' to be discovered - namely, using RFID to provide unique identification of individual items or packs at production line speeds. Hitherto, cost has been a major issue, especially in industries with many high-volume, own-branded products, low-value and low-margin products - the food industry, for example. When margins are low, who is going to apply an RFID tag costing 25 cent or even 20 cent, let alone pay extra to have it applied and install new scanning or reading equipment and data collection software?
In the pharmaceuticals and healthcare sectors, there appears to be a different state of affairs. As well as powerful drivers in the form of regulation - actual and potential - there is a belief (among outsiders) that money is no object: "There's so much profit in the market," the argument goes, "that they can afford to add RFID tags to everything - right down to item or dose level."
This is a myth. While regulation does indeed drive manufacturers towards a cost-effective, high-speed, uniquely identifiable, track-and-trace system, the majority of bulk pharmaceutical or healthcare items are low-value and low-margin, such as pain-killers sold in supermarkets and pharmacists. These packs may cost less than 15p at retail, to cover all licensing, ingredient, manufacturing, packaging and distribution costs and, hopefully, some profit. They are not candidates for RFID tags.
Like food and other FMCG sectors, pharmaceuticals and healthcare need a solution for the whole global supply chain - a range of interoperable, interchangeable data carriers that meet global compliance regulations and offer low-cost or high-security options, and hopefully both.
At Domino we have been working with a leading global brand pharmaceutical manufacturer to develop just such a solution - one that not only applies globally-compliant unique codes at item level, but which also applies RFID tags on individual product labels. Furthermore, the information included within the data carriers is compliant with all current global standards as required by the national pharmaceutical regulators and FDA, incorporating information such as Expiry Date, Lot Number and Product Identifier (GTIN) and with the capacity to include a unique serialized number or code such as an EPC number. After a successful trial, the solution is now being rolled out across Europe.
Three-stage process
It has been a three-stage process. In Stage 1 we had to 'prove the concept': developing a printed code platform that allowed each item to be given an individual, uniquely identifiable code that could be read and verified, (passed or rejected) as part of the manufacturing/production process; and confirming that this could be repeated along the production line at every stage (primary, secondary, tertiary), identifying each level of packaging uniquely and networking the input, transfer, recording and distribution of the data throughout the manufacturing process.
Crucially, we worked on the principle that using existing equipment would cut costs, improve the ROI case and minimize disruption to production. The plan was to create a migration path to take the production plant from its existing simplistic level of coding and tracking to, in the future, a highly sophisticated coding, tagging and data management system providing complete track, trace and match. This would offer coding or tagging options at each level of packaging (unit-dose, item, pack, multiple, case, pallet) and the data management structure to support it. As technology develops, printed codes, tags or other devices can be interchanged simply by connecting them to the software backbone that controls the data. And all of this activity must comply with industry standards.
Which data carrier to incorporate was a key consideration. We quickly discarded EAN13 as its generic GTIN structure would not allow encoding of even the most basic compliance requirements (i.e. Expiry Date and Lot Number). We considered carriers such as EAN128 and the specialist RSS (Reduced Space Symbology) but decided against these for various reasons. EAN128, though ideal at case and pallet level with its ability to incorporate additional information through its Application Identifier (AI) structure, was simply too large for many product packs at item level; while RSS codes, though much smaller, proved complex and difficult and slow to print and read at production line speeds.
RSS did offer one benefit. Early FDA bar code implementation asked for a linear element for reading of GTIN/product number element - something to which RSS could readily comply. However, the 'stacked'/composite structure proved in many instances to be difficult to print, fragile in use (open to damage) and slow to read/validate in volume production environments.
We settled on the Data Matrix 2D or composite code. Highly regarded for its robust structure and the volume of data that it can encode in a very small space, it was until relatively recently a proprietary 'branded' code and not part of the EAN.UCC/GS1 family of global, openly accessible and royalty free bar codes. This restricted its widespread adoption in high-volume markets such as FMCG and pharmaceuticals/healthcare. However, this situation changed when the rights were passed to GS1.
In addition to unique Data Matrix codes, human-readable text showing Lot Number and Expiry Date was also incorporated within a small item level label. This process was tested 'off-line' at the first stage.
Print the label
Stage 2 was to print a label with a linear code as part of the pre-printed label as a generic element for internal logistics use. An RFID tag was laminated into the label structure and then a unique Data Matrix code and human readable element was printed using a Domino laser 'on-the-fly' (on demand) as part of the filling and packing process within the manufacturing unit. Each code and tag is written or read online and the product 'passed' or 'rejected' at every stage to ensure 100% readability throughout the process.
Working at full speed
Stage 3 has been to bring everything together at full production-line speeds. Vital to the success of the process is managing, inputting, checking, collecting, storing and disseminating data. From the first point at which data is transferred into a tag or code, until the finished item is passed to the warehouse via the WMS or logistics process, the data must be managed efficiently and securely. Using an EPC system unique numbers must be issued, applied, verified as correct and the data effectively 'published' via a discovery service or some form of data pool. This looks straightforward in principle, but 'input, print, check, pass or reject and move on' becomes much more difficult at full production-line speeds in excess of 120 items/minute.
Many initial trials using RFID tags or composite codes have used desk-top printing units and handheld scanners/readers - essentially 'slap and ship' as it is known in the industry. These systems are very effective for low-volume or low-speed lines, but at faster speeds throwing people at the problem is not an option - it would send costs (and hence the ROI) off the Richter scale.
At this point modern automated, high-speed application, data-input, verification, data-output and transfer become the real issues, and, we believe, manufacturers need to seek out specialist companies such as Domino. We can print and/or apply alphanumeric codes (date, time, internal product codes), linear bar codes (almost any), and composite codes (almost any), and write, read and apply RFID tags when and where required - at primary, secondary and tertiary levels within production environments.
For further information please contact Gary Page, US Business Development Manager, Domino Integrated Solutions Group at Domino Amjet: GPage@dominoamjet.com.
