ISO 17025-certified sensors for drug transportation

Highly regulated products, such as pharmaceutical or perishable goods, typically require special handling along their distribution chain to comply with several directives. Manufacturers are obligated to cover distribution in their overall quality system and must continuously adapt to adhere to current Good Distribution Practices.

The most regulated parameter is temperature, which determines not only the lifetime, but also the usability of a product. Reliable temperature monitoring in the complexity of a modern logistics network in turn requires trustworthy dataloggers, which are increasingly (pushed by regulations such as EN 12830) accepted only with certification from accredited laboratories (ISO 17025).

Today, loggers are typically equipped with several electronic components and often still with analogue temperature sensors, which makes accredited calibration of the complete device necessary, a time-consuming and expensive step which could be avoided using next-generation temperature sensing strategies.

The STS32 and STS33 are Sensirion’s new high-accuracy ISO 17025-certified digital temperature sensors optimised for cold and frozen chain applications. Both rely on the industry-proven CMOSens Technology, enabling increased computational power, reliability and improved accuracy specifications compared to their predecessors. Their functionality includes enhanced signal processing, two distinct and user-selectable I2C addresses and communication speeds of up to 1 MHz. The DFN package has a footprint of 2.5x2.5mm2 while keeping a height of 0.9mm.

Every STS32 or STS33 is identified by its unique serial number and is supplied with an ISO 17025-accredited calibration certificate. The calibration certificate comprises three temperatures, -30°C, 5°C and 70°C. In addition to the certified temperature sensors, Sensirion is introducing the SHT33 humidity and temperature sensor as the new flagship of the certified sensor family. The SHT33 is based on the proven SHT3x series, offering highest accuracy and quality standards combined with ISO 17025-certified temperature sensing on one chip.

“As the first ISO 17025-accredited semiconductor company in the world, we are able to offer customers this disruptive and forward-thinking sensor solution for GDP-compliant datalogging,” said Matthias Scharfe, Product Manager Humidity Sensors at Sensirion.

Calibration certificates and data for each STS32, STS33 and SHT33 sensor can be downloaded from a server address given in the shipment documents, enabling efficient processing by automated systems. In turn, STS32 users not only embed sensor hardware into their product but are also able to merge the provided calibration data from the sensor with the calibration information needed for their dataloggers.

This approach heavily simplifies the manufacturing process, as the typically expensive and time-consuming calibration of the assembled device is replaced and completely covered by using a digital, pre-calibrated temperature sensor, all while meeting the stringent quality requirements of the pharmaceutical and medical industries.