A pharmaceutical company was faced with the challenge of carrying out several autoclave validation runs at short notice. Its own pool of validation equipment was already fully utilized, while the project still had to be completed on time and in full compliance with GMP requirements. To meet these demands, the company decided to use the new ebro® rental data logger service.
The validation setup included twelve temperature data loggers and two pressure data loggers from the EBI 12 series, an interface for fast data readout, and—used for the first time—a qualified rental laptop with preinstalled and validated Winlog.validation software. As all data loggers were delivered fully calibrated, additional time-consuming calibration steps were avoided, significantly accelerating the project start and reducing overall costs.
The validation itself proceeded smoothly. The data loggers were positioned at the critical locations within the autoclave, multiple validation cycles were performed, and the data was subsequently analyzed using Winlog.validation. Particularly valuable features included automatic cycle detection, F₀ calculations, and FDA- and GMP-compliant reports with complete audit trails, which could be directly integrated into the validation documentation.
The results were convincing: the customer benefited from substantial time savings, a cost-efficient solution, and reliable, validated documentation. This first use of the new ebro® rental data logger service clearly demonstrated that ebro® offers a flexible, regulatory-compliant, and economical solution for short-term validation projects—providing data loggers, software, and hardware from a single source.
