CLEAN ROOM MONITORING WITH PARTICLE COUNTERS
Bakrona provides not only the sensors for the clean room monitoring, but also implements overall solutions for continuous clean room monitoring in a GMP environment. The clean room monitoring systems meet the cGMP requirements.
MONITORING SYSTEMS FOR CLEAN ROOMS AND PROCESSES
Bakrona assumes by request the project responsibility from the definition of the URS to the handover of the monitoring system. This includes project management, installation, commissioning (FAT, SAT, IQ /OQ), calibration, documentation and user training.
Bakrona monitoring solutions can be realized with components from leading manufacturers. We integrate our sensors for particles and other environmental parameters in your application.
Bakrona provides engineering support, service and recalibration for the supplied equipment (particle counters and other sensors).
CONTINUOUS MONITORING WITH AEROSOL PARTICLE COUNTERS
The “point-of-use” particle counters are usually permanently installed at several points within a clean room and connected into one clean room monitoring system to continuously monitor for particles
The critical locations are evaluated by applying a risk analysis and the current regulations (EU-GMP Annex 1, PIC / S, FDA).
Models with or without internal vacuum pump allow for maximum flexibility in designing the monitoring system.
Bakrona has many years of experience in the planning, dimensioning and manufacturing of customized sampling systems.
By means of true to scale simulation models we fit the sampling systems on site. This allows the customer already during the planning phase to determine the optimal sampling location, both from an operational and from a regulatory perspective.
CLEANROOM MONITORING SOFTWARE
In the clean room monitoring software, measurements are visualized, monitored for critical values and stored. They are available for later evaluations.
Reports and graphics of the monitoring readings can be printed automatically or by manual activation.
The systems are compliant to FDA 21 CFR Part 11 and GMP Annex 11.