By Ed Dietrich, Director, Americas, Reconnaissance International. Ltd.
The project was commissioned by one of the worlds top 20 pharmaceutical companies and a leader in authentication since the late 1990s (the company declined to be mentioned for this article). Originally using holograms, as well as covert technologies, and today using color-shifting inks and multiple covert elements in their labels and packaging, this is a sophisticated customer who benefits from the experience of having developed and implemented successive generations of authentication solutions.
Extending authentication strategy
In November 2004, in another extension of its authentication strategy, the company announced an initiative to use RFID tags intended to enable wholesalers and pharmacies to authenticate one of its top drugs sold in the U.S. This project is intended to support FDA efforts to promote the development of standards and processes in preparation for RFIDs broader use across the pharmaceutical industry. In announcing this pilot project, the company said that it planned to begin shipping RFID tagged product by the end of 2005. With barely a year to reach its goal of shipping product tagged with RFID, the company sourced three companies, each bringing a different piece of what it needed, together:
- TAGSYS for the RFID tags and readers;
- SYSTECH for RFID middleware;
- SupplyScape for electronic pedigree software.
Systech International has been a provider of packaging management software for manufacturing operations and machine vision systems since 1985. Its family of packaging software was developed to meet the needs of inspection, control, and information management in regulated packaging environments such as the pharmaceutical, medical device, biotechnology and healthcare industries and today it counts 18 of the top 20 pharma companies as customers. Its TIPS product tracking software enables the capture, correlation and matching of barcode data on the primary package label with the RFID tag attached to that unit at packaging line speeds and is providing the data backbone for the development of the product information database inside the manufacturing facility, states Joe Costa, Systech Director of Marketing.
SupplyScape was founded in 2004 to develop electronic pedigree software to answer the growing need within the pharmaceutical supply chain and regulatory community. Founding members include Robin Koh, who was formerly Director of Applications Research at MIT's Auto-ID Lab. The company has been involved with many of the pioneer projects in E-Pedigree including Purdue Pharmas initiative to track its OxyContin painkiller with RFID technology.
High level of coordination
The scope of the project is ambitious and has required a high level of coordination and involvement on the part of the partners, as well as the pharma company. Even with limiting the project to only this particular product distributed in the U.S., you are looking at millions of units. The company intends to assign a unique EPC number to each unit tracked, and then aggregate that data into parent/child relationships with separate tags for each shipping carton, and palette of product. The company has selected HF (13.56 MHz) labels for the item tagging and UHF tags for the palette and case levels. All of this data must be assigned, written to the RFID tag, collected and organized at packaging line speeds, which can often be up to hundreds of units per minute. In addition, the company will print a barcode containing the identical EPC information in the RFID chip on the face of the label, for readability in those areas where RFID readers are not yet available.
Creating and executing a project of this kind, one which is breaking ground in a new area of product tracking is challenging, but made even more so by the demands of a regulated market like pharmaceuticals. In normal pharma packaging operations, labels must undergo 100% inspection and reconciliation, placing high expectations on both the reliability of the tags, and their ability to be applied consistently and at speed in the plant environment. Any irregularities in printing on a label mean rejection, since a smudge or dropout in printing on a pharma label could provide incorrect information relative to prescription and proper use, with serious potential consequences.
But once these hurdles are overcome, one of the biggest challenges for this pilot will be the infrastructure which will need to be installed, and the people who will need to be trained for the RFID tags to actually be read and verified in the field. The ultimate value of the added investment of RFID will only be realized if data collected in the field about the movement of product through the supply chain can be associated with the original EPC codes and point of manufacture in order to provide a true E-Pedigree from plant to patient. Field procedures will need to be developed and implemented to manage incidents of corrupted or destroyed tags and to authenticate (presumably using the companys current authentication technologies), whether or not the contents of product with destroyed or corrupted tags is genuine.
Great business potential
While all of this development is resource-intensive and costly for Systech, Tagsys and SupplyScape, the business potential is great. Beyond expanded business with the sponsor company, which could stretch to hundreds of millions of units per year, the knowledge that these three companies gain from this collaboration should prove invaluable as the majority of global pharma companies move to implement RFID tracking in response to federal and state pedigree requirements once the technology is proven.