Biopharmaceutical production must meet strict environmental cleanliness regulations. GMP (Good Manufacturing Practice) mandates continuous monitoring and recording of cleanroom temperature, humidity, differential pressure, and suspended particle concentration. Any excursion events must trigger timely alarms and ensure full traceability.
A biopharmaceutical company constructing a new antibody drug production facility required an environmental monitoring system compliant with both Chinese GMP and EU GMP standards. The project covered over 30 cleanrooms across A/B/C/D grades, with more than 200 monitoring points.
NeuronTech developed a comprehensive environmental monitoring system for the project: temperature and humidity were measured using high-precision capacitive sensors with an accuracy of ±0.1°C / ±1.5%RH;; differential pressure was monitored via micro-differential pressure sensors with a range of 0-500 Pa and a resolution of 0.1 Pa; particle counting utilized laser scattering counters covering 0.5μm and 5μm size channels.
The system uses distributed acquisition with centralized management. Each monitoring point sends real-time data via industrial Ethernet to a central server. The software platform delivers real-time dashboards, trend analysis, limit-exceedance alerts, and electronic records to ensure Data Integrity compliance.
After launch, the project passed GMP certification inspection by pharmaceutical regulators. The inspection team validated data integrity in environmental monitoring and confirmed system reliability. This solution is now NeuronTech's standard delivery template for the biopharmaceutical industry.