How RFID Is Changing The Pharma Cold Chain

By Lee Marts

Life sciences products have grown more complex, and this complexity often increases product value — and sometimes — temperature sensitivity. Either outcome places a greater burden on cold chain professionals to reduce risk.

Many companies consider wireless technologies to improve temperature monitoring efficiency. RFID is a primary component of this approach. In common usage for the past 20 years, RFID loggers (i.e. tags) store product information in a similar fashion to bar codes. Unlike bar codes, however, they wirelessly transmit data without requiring a clear sightline or close contact with a reader.

Temperature monitoring tags with RFID technology incorporate a sensor that captures the ambient temperature at specific intervals. Sensors are calibrated to detect high and/or low temperatures. Any temperature excursion triggers a visual indication on the tag and also records the temperature, date, and time.

The tough, flexible RFID packaging, about the size and weight of a matchbook, fits well in harsh shipping environments with limited space. In addition to eliminating bulky, sensitive electronic devices, RFID tags speed access to temperature monitoring data.

The Advantages Of RFID
Wireless capabilities allow workers to start, stop, or read the tags without opening boxes. Data from thousands of tags can be captured and reviewed on mobile readers before being downloaded to a PC. Traditional monitoring devices, in contrast, must be unpacked from boxes and taken to a PC for downloading. Report generation often occurs off-site, days later. As a result, RFID tags offer much faster data retrieval.

Another advantage of RFID temperature monitoring involves logistics, with its goal to save time and costs. The benefits of wireless data access, compact packaging, toughness, reusability, and streamlined handling and administration simplify temperature monitoring processes, reducing expense. In addition, RFID tags offer a low cost per use. More important, the logistical benefits favor widespread use of the devices for greater coverage and risk reduction.

Along with simplified logistics, ease of use contributes to the effectiveness of a temperature-monitoring solution. Unskilled shipping workers are less likely to take precautions with sensitive electronic devices, or know how to process or use them. The design of RFID tags encourages interaction. A flashing LED indicates a temperature excursion. Simple directions tell the user to push a button to stop recording. Some versions even embed the logger in a postage-paid postcard for easy processing.

The search for streamlined temperature monitoring represents a growing need for precise monitoring of product quality and care through faster data access. It’s especially critical for life sciences products, where temperature excursions may have dire consequences. In pharmaceuticals, for example, shipments worth millions of dollars are at risk. Temperature damage to biologics, medical devices, clinical specimens, and medicines may affect people’s health or endanger lives.

Regulations Drive RFID Adoption
Regulatory guidelines highlight the primary role RFID will play in the life sciences industry. The FDA’s Compliance Policy Guide (Sec. 400-210) “Radio Frequency Identification Feasibility Studies and Pilot Programs for Drugs” states: “We believe that use of RFID technology is critical to ensuring the long-term safety and integrity of the U.S. drug supply.”

While the FDA study focuses on counterfeit drugs, the targeted completion date of Dec. 31, 2012 will likely have implications for the overall safety of these products. The guide further explains that RFID tags may include other information, such as storage and handling conditions. Temperatures and expiration dates fall under these categories and will need to be monitored. Whatever the study outcome, the FDA clearly states that the December 2012 date “should provide sufficient time for the industry to gain experience with RFID technology.”

It’s only a matter of time before smartphones take on a new role in the cold chain of life sciences companies. Smartphone temperature monitoring apps already exist that read RFID tags. They provide immediate insight and instantly upload data to cloud applications for access throughout the organization by authorized users.

Lee Marts is the quality assurance and regulatory affairs manager for American Thermal Instruments, Inc. He received  a Bachelor of Science degree from South Dakota State University in agriculture and education, and has 30 years experience in education and manufacturing.