Improving the pharma cold chain

Santa Clara, CA, US:  The latest generation battery assisted passive (BAP) RFID temperature monitors give the ability to see through a box or carton in-transit without unpacking reducing or eliminating the issues associated with traditional data loggers.

“This enables significant improvements in pharmaceutical cold chain logistics,” says Peter Norton, supply chain consultant to Intelleflex Corporation, a US-based company that earlier this year launched its RFID monitoring solutions in Europe.

“The passive RFID temperature monitors help identify potential excursion conditions before they become a problem and provide a complete chain-of-custody history of the product from manufacturer through the last mile”, Norton says.

Traditional temperature monitoring solutions, such as chemical indicators or USB data loggers, are limited in their ability to reduce loss during shipment from the factory to the consumer because they cannot provide real-time information about the status of the product while it is in transit.

“Traditional data loggers are typically inserted into the packaging at the manufacturing plant before the package is sealed.  Packages are then shipped, using a courier or 3PL, along certified routes and ultimately delivered to the customer.  Once the package is received, the temperature monitor can be accessed and, ultimately, a record of the product’s temperature history can be retrieved.”

There are challenges with this process model including:

  • there is no way for out of refrigeration checks in the warehouse.
  • you cannot check the condition of the product’s condition at the first point of shipping.
  • there is no ability to check the condition of the product at any intermediate point in-transit so no ability to take action on issues.
  • product and condition checks – with alarms and excursions – can only be seen after the package is delivered and opened and the monitor is physically checked.

Battery assisted passive (BAP) RFID temperature monitors have the ability to monitor the temperature inside the box where the product is located (not the ambient case temperature) in-transit provides the following efficiency improvements:

  • conditions of the product can be monitored at all points of the warehousing and shipping process.  This enables visibility into operational discrepancies and real-time condition of the product.
  • all condition recordings (logged data) can be done without opening the package and compromising the security of the product.
  • the temperature and condition monitoring tags are re-usable (2 year battery life) and can be read for up to 10 years for shipment audit checks and forensic records (3600 data points).
  • a chain-of-custody report can be obtained via the RFID reader.

Kevin Payne, senior director of marketing at Intelleflex

Traditional cold chain logistics temperature monitoring processes rely heavily on the combination of validated/profiled routes along with tested processes to insure that drugs and biologics are delivered to the final point of the supply chain in the expected condition.  In this traditional model, the temperature monitoring devices (generally USB or chemical) are used as a “fail-safe” method to confirm that the expected results inside the carton have been maintained throughout the entire delivery cycle.

“Unfortunately, this approach has many flaws.  It doesn’t provide for a non-intrusive method for checking to see if the desired conditions are being maintained within the approved limits throughout the entire journey.  Additionally, with an increase in counterfeiting and drug diversion, the traditional method does not provide any record related to a chain-of-custody, other than perhaps a signature on the outside of the carton or a paper shipping record,” Norton says.

“With the new “breed” of RFID battery assisted passive tags it is now possible to have the ability to monitor real-time conditions through the carton and take any corrective actions that may be appropriate at various points along the cold chain.

“It is also possible to record a chain-of-custody log based upon established, secure way-point checks and log a basic e-Pedigree record within the tag’s memory to form part of an overarching anti-counterfeiting strategy.”

“The benefits of moving to this next level of efficient cold chain logistics monitoring devices are many but ultimately it comes down to two major reasons: maintaining the efficacy and quality of the drugs delivered to the patient, and mitigating the risk to bottom line revenues due to a rejected shipment related to temperature excursions.”

“At a cost much less than traditional monitoring devices, any drug or biologics company can now utilize Battery-Assisted Passive RFID solutions to take their cold chain logistics processes to the next level and provide better protection to their bottom line and to their patients while increasing their reputation for providing a quality product,” says Kevin Payne, senior director of marketing at Intelleflex.