ISO 17025-certified sensors protect drugs in transit

Calibrated and ISO 17025-certified temperature, and humidity and temperature sensors from Sensirion are used by customers to achieve cost-efficient GDP-compliant supply chain monitoring of drugs, vaccines and perishable goods.

Highly regulated products, such as pharmaceutical or perishable goods, typically require special handling along their distribution chain to comply with directives. Manufacturers need to adapt to ensure they adhere to current good distribution practices.

Temperature is the most regulated parameter and determines the lifetime of the product and usability of a product. Reliable temperature monitoring requires reliable dataloggers, which are increasingly changing, for example, the introduction of EN 12830 and accepted only with certification from accredited laboratories (ISO 17025). Dataloggers typically have several electronic components and often analogue temperature sensors, which makes accredited calibration of the complete device necessary. This step take time and adds expense but could be avoided using temperature sensing strategies, said Sensirion.

The STS32 and STS33 digital temperature sensors are ISO 17025-certified and optimised for cold and frozen chain applications. Both rely on CMOSens technology, which is claimed to enable increased computational power, reliability and improved accuracy specifications compared to earlier temperature sensors. The sensors have enhanced signal processing, two distinct and user-selectable I2C addresses and communication speeds of up to 1MHz.

The DFN package has a footprint of 2.5 x 2.5mm2 and a low height of 0.9mm.

Every STS32 or STS33 is identified by a unique serial number and is supplied with an ISO 17025-accredited calibration certificate. The calibration certificate comprises three temperatures, -30, +5 and +70 degrees C. In addition to the certified temperature sensors, Sensirion has introduced the SHT33 humidity and temperature sensor. This is based on the proven SHT3x series and is claimed to offer high accuracy and quality standards combined with ISO 17025-certified temperature sensing on one chip.

Calibration certificates and data for the STS32, STS33 and SHT33 sensors are available for download. STS32 users can not only embed sensor hardware into a product but are also merge the calibration data from the sensor with the calibration information needed for dataloggers. This 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, while meeting the stringent quality requirements of pharmaceutical and medical industries.

Picture credit: Parcel transport by truck / Source: Istockphoto

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