How Eurotherm helps compliance with the revised requirements
Several new requirements and recommendations are included in the updated version of Annex 1, and they can represent compliance challenges for many sterile drugs manufacturers. To support life science companies’ compliance with the revised document, Eurotherm focuses priority on the following topics:
Environmental Monitoring Systems
Eurotherm EMS Digital Engineered Solution can monitor temperature, humidity, pressure, particle counters, and contamination according to the new guidance. Our EMS DESs leverage strategic partnerships to deliver pioneering solutions.
Indicator of air pressure differences
According to Annex 1 air pressure differences should be continuously monitored and recorded. Eurotherm provides a simple solution, embedding Eurotherm Store and Forward technology, to help reduce the risk of data loss, avoiding gaps in the historian database, and to support the Data Integrity ALCOA+ principles. Warnings and alarms are delivered to on-premise or cloud-based repositories and mobile devices.
Sterilization by heat
As a leading global supplier of data management technology, Eurotherm designed a solution to help OEMs and end users to meet point 8.50 of EudraLex Annex 1, by providing off-the-shelf monitoring solutions and redundant control solutions that are cost-effective, easy to qualify and sustain good manufacturing processes.
Learn how Eurotherm helps compliance with point 8.50 of EudraLex Annex 1 >
