Industry unveils disruptive biopharmaceutical cold chain monitoring solution
Biopharmaceutical products (vaccines, hormones, blood) play an increasingly important role in the pharmaceutical industry. To be effective and safe, these products have to be kept in the cold chain from production to administration. Cold chain monitoring is mostly done using either chemical temperature loggers or reusable electronic loggers, both are inadequate.
Chemical temperature loggers can only detect simple cold chain excursion and do not indicate when the event occurred. Reusable electronic loggers are expensive and bulky, therefore only deployed at pallet and not item level. Moreover it is cumbersome to recycle them.
NXP and Enfucell have jointly developed a disposable temperature logging foil demonstrator. This solution supports logging functionality similar to that of a reusable logger, but form factor and product cost do enable item level logging. The foil contains NXP's NHS3100 IC, Enfucell's printed battery and an NFC antenna.
NXP's NHS3100 is a single chip solution for temperature logging. It integrates a very accurate [0.3⁰C] temperature sensor, an NFC interface, an accurate time reference, a non-volatile temperature logging memory and programmable Cortex M0+ processor. The programmable architecture offers biopharmaceutical manufacturers the option to define a product-specific temperature excursion limit profile. Different from the simple caloric model used in chemical loggers, the more elaborate profile can minimize product waste in the logistic chain. The internal time reference offers traceability across the logistics chain of exposure beyond excursion limits. The embedded NFC interface supports read-out of the product's status by means of an NFC-enabled smart phone or reader, at any point in the logistic chain or by medical staff administering the product.
Enfucell's battery technology offers a thin, flexible and eco-friendly power source which can be printed onto the flexible foil. The demonstrator's battery capacity, along with the ultra-low power characteristics of NHS3100, offers a shelf life of 1 year, and supports active logging for 2 years after activation.
This solution will support reduction of biopharmaceutical waste, increase safety and efficacy of biopharmaceutical products, provide visibility when and where the product was handled incorrectly.
Provided by NXP