Pharmaceutical manufacturers are required to requalify their production facilities annually in accordance with GMP requirements. During steam sterilization, all critical points must be monitored: extensive piping systems, installed components such as filter housings, vessels, and valves, as well as various worst-case locations. The objective is to verify the actual lethality at every relevant point within the system.
This task is complex, as different components impose different requirements on the measurement technology. Working closely with the customer, we developed a tailored solution: compact EBI 11 data loggers were used for small filter housings and vessels, while EBI 12 data loggers were deployed for larger installations. Measuring inside the piping presented a particular challenge. Here, the flexible temperature probes of the EBI 12 series were used, which could be inserted directly into the center of the pipes via special Tri-Clamp connections and customized sealing solutions.
This combination allowed all critical locations to be reliably monitored using the most suitable data logger technology. Subsequent data analysis with Winlog.validation provided complete and traceable documentation, including automatic cycle detection, F₀ calculations, and GMP-compliant reports.
The result: the annual requalification was completed efficiently, safely, and in full regulatory compliance—thanks to the optimal interaction of EBI 11 and EBI 12 data loggers, application-specific probe solutions, and validated evaluation software.
This success story highlights the flexibility and performance of the ebro® validation data logger portfolio and demonstrates how even complex requalification tasks can be supported efficiently and in a GxP-compliant manner.
