Pharmaceutical products, such as vaccines, are highly regulated and typically require special handling along their distribution chain. 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 also the usability of a product. This often requires a product lifetime temperature profile within a narrow band.
Reliable temperature monitoring in the complexity of a modern logistics network therefore requires trustworthy data loggers, which are increasingly (pushed by regulations such as EN 12830) accepted only with certification from accredited laboratories (ISO 17025). ELPRO offers a wide range of data logger solutions for every customer need. The LIBERO Cx multi-use series with Bluetooth® provides the foundation for next-generation independent monitoring solutions for products with known stability data.
Going a step further, the LIBERO Gx series enables real-time data logging, providing 24/7 access to shipment, location and condition data, including temperature, humidity, light, tilt and shock. The 1-year battery life protects shipments further and longer around the globe. The LIBERO Gx family has the widest available measurement range for real-time condition monitoring of 200°C to +400°C.
“At ELPRO, we live and breathe quality and compliance – they are the foundation of our customer relationship and the trust in our products and services. For this purpose, we have to ensure that the chips for our temperature data loggers correspond exactly to the specifications that were defined during development. The nature and scope of routine checks and controls is heavily dependent on Sensirion, who has been the perfect partner in the development of these chips and has incorporated the needs of ELPRO and our customers into production,” says Björn Niggemann, Chief Quality Officer at ELPRO.
ELPRO’s data logging solutions rely on Sensirion’s STS32 sensor, a digital, I2C-based temperature sensor that features GDP (Good Distribution Practices)-adapted accuracy specification and includes a three-point calibration certificate provided by Sensirion’s new ISO/IEC 17025:2017 accredited calibration laboratory. Calibration certificates and data for each STS32 can be downloaded from a server address given in the shipment documents. In turn, STS32 users not only embed sensor hardware into their product, but can also merge the provided calibration data from the sensor with the calibration information needed for their loggers.
“ELPRO’s data logger solutions are a perfect application for our new certified STS32 temperature sensors and are at the forefront of the industry. The successful partnership between Sensirion and ELPRO is fueled by the mutual ambition to offer innovative high-quality products and brave new solutions,” says Matthias Scharfe, Product Manager Humidity and Temperature Sensors at Sensirion.