GDP-compliant data logging powered by digital temperature sensors including ISO 17025 calibration certificates

Sensirion, the environmental sensing expert, is proud to announce that the new STS32 temperature sensor will be available from October 2020 onward. This digital sensor comes with an ISO 17025-accredited, three-point calibration certificate. The calibration data and the sensor specifications are compliant with good distribution practices (GDPs) for pharmaceutical and medical logistics. Data logger manufacturers can eliminate costly and technically challenging calibration operations by integrating the STS32 into their loggers.

Pharmaceutical logistics is quite a strongly regulated industry. When medical or pharmaceutical products are being shipped, minute temperature monitoring has to be maintained to guarantee both product and patient safety. One particular quality requirement concerns the three-point temperature calibration of the loggers used, demonstrating their suitability. With the analog temperature sensors commonly used in the past, the whole measurement chain had to be calibrated, which limited calibration scalability and cost optimization. Meanwhile, digital sensors incorporating the complete measurement chain on a chip allow pre-calibrated temperature sensors to be used in data loggers, eliminating the need for the manufacturer to perform additional calibration procedures.

Based on the versatile STS3x platform, the STS32 is a digital, I2C-based temperature sensor. It features a GDP-adapted accuracy specification and includes a three-point calibration certificate provided by Sensirion’s new ISO/IEC 17025:2017 accredited calibration laboratory. The calibration setpoints are T = -30°C, 5°C, and 70°C. All the values are provided in a machine-readable CSV file format and can be associated with the sensor in question by using the sensor’s unique, unalterable serial number. The metrological traceability of the calibration conforms to Chapter 6.5 of ISO/IEC 17025:2017, commonly referred to in relation to NIST traceability or traceability to other national metrology institutes, in accordance with the CIPM Mutual Recognition Arrangement (CIPM MRA).

Calibration certificates and data for each STS32 sensor can be downloaded from a server address given in the shipment documents, enabling efficient processing by automated systems. STS32 users can merge the calibration data provided by the sensor with the calibration information needed for their loggers. The calibration process can therefore be completely covered by using a digital, precalibrated temperature sensor, all while meeting the pharmaceutical and medical industries’ stringent quality requirements.