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Parexel Tests System to Track Temperatures of Test Drugs

The biopharmaceutical services company wants to monitor the temperatures of drugs being shipped to clinical trial participants, using an RFID-enabled sensor and cell phone.
By Claire Swedberg
The system has multiple flaws, however. For one thing, it's time-consuming, as employees are responsible for either visually reading the loggers and recording the data, or downloading that information via a USB cable. Typically, by the time that function has been completed and Parexel receives the data and either approves the product or rejects it, 24 hours have passed. That, Norris says, results in waiting time for investigators. "We're responsible for ensuring the integrity of the drug," he states.

Regulations have been getting more stringent regarding the environmental conditions of the products as they ship, Norris says, while pharmaceutical companies have been seeking a solution that would make their supply chain safer and more efficient.


Jens Mattuschka, Parexel's director of clinical logistics services worldwide
Earlier this year, Parexel began developing a solution that utilizes active 13.56 MHz tags complying with the ISO 14443a and 15693 standards, and supports the Near Field Communication (NFC) specifications. The challenge, the company reports, was to develop a solution that would be easy to use by trial investigators, and that would operate in any part of the world. The system Parexel developed employs Cypak's CPK082 NFC sensor chip in a mobile phone to receive transmissions from the tag and the phone, and then forward that data to Parexel's server via a cellular connection.

During the proof-of-concept pilot, held earlier this year, liquid-filled bottles (actual medications were not used during the pilot) were encased in packaging provided by Parexel that included two layers of corrugated paper placed inside a cardboard box, along with a temperature sensor that is wired to an RFID tag embedded in one side of that box. The tag was activated by a pharmacist specializing in shipment preparation for investigational medicinal products, using an RFID-enabled Nokia mobile phone, and the date and time stamp for this activation were sent to Parexel's server.

The box packed with the bottles was then placed in a carton, along with a Nokia mobile phone. Throughout the supply chain—from a depot in Europe to the receiving party, which was typically a health-care provider or a pharmaceutical company—the sensor read the temperature within the box at a rate of once every 10 minutes. The RFID tag then stored that information, along with date and time stamps. When the carton reached its destination, the clinical investigator—in most cases, a physician—unpacked the mobile phone and turned it on, then waved the phone, with a built-in NFC reader, over the box, thereby capturing the RFID tag's ID number, as well as the temperature data stored in its memory.

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