Sensirion offers new calibrated and certified temperature and humidity& temperature sensors for cost-efficent GDP-compliant drugs, vaccines, and perishable goods supply chain monitoring.

Highly regulated products, such as pharmaceutical or perishable goods, typically require special handling along their distribution chain to comply with several directives such as the Prescription Drug Marketing Act of 1987, 21 CFR Part 203, Prescription Drug Marketing, and Part 205, or Guidelines for State Licensing of Wholesale Prescription Drug Distributors. Manufacturers are obligated to cover distribution in their overall quality system and must continuously adapt to adhere to current Good Distribution Practices for the pharmaceutical or perishable goods supply chain (also see PDA Technical Report #52). The most regulated parameter for drugs and perishable goods is temperature, which determines not only the lifetime, but the usability of a product. This often requires a product lifetime temperature profile within a narrow band.

Calibration for Reliable Temperature Monitoring over the Product Lifetime

Reliable temperature monitoring in the complexity of a modern logistics network requires trustworthy dataloggers, which are increasingly accepted only with certification from accredited laboratories (ISO17025). 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.

Sensirion, the first ISO17025-accredited semiconductor company in the world, has introduced a new series of ISO17025 calibrated digital sensors for a great variety of applications where precise and reliable measurements are required: Based on the versatile STS3x and SHT3x platforms, the STS32, STS33, and SHT33 are a digital, I²C-based temperature and humidity and temperature sensors, respectively. Metrological traceability of the calibration is conforming to ch.6.5 of ISO/IEC 17025:2017, commonly referred to NIST traceability or traceability to other national metrology institutes, according to the CIPM Mutual Recognition Arrangement (CIPM MRA).

Have a look at Sensirion's achieved ISO17025 certification.