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.
System engineering, commissioning and clean room qualification are carried out by experienced professionals.
Customized monitoring solutions by Bakrona
- Monitoring overall solution with PMS particle counters and PMS PharmNet software
- Clean room monitoring system with PMS particle counters and iFix software from GE Fanuc
- Integration of our sensors for particles and other environmental parameters into your application.
Reliable measuring instruments
Particle counters from PMS
The PMS "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 small and compact particle counters are sturdy, suitable for clean rooms and have proven themselves in continuous use.
Measuring instruments for ambient parameters
For the measurement and monitoring of other clean room ambient parameters such as temperature, relative humidity, air velocity and differential pressure, Bakrona uses products that have also proven themselves over many years in industrial applications. This ensures a high availability of the monitoring system.
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.
Qualification, training and maintenance
The clean room monitoring systems meet the current validation guidelines and the 21CFR Part 11 regulations.
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 provides engineering support, service and recalibration for the supplied equipment (particle counters and other sensors).