Facility Monitoring System (FMS)
Air Particle Counters for Cleanroom and Environmental Monitoring
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In today’s world, various industries (primarily pharmaceutical and microelectronics) cannot be imagined without cleanrooms. By definition, a cleanroom is a room where the generation of particles such as dust, microorganisms, aerosol particles and chemical vapors in the air is minimized and the size and concentration of such particles are maintained within a certain specified range. Continuous monitoring systems are used to monitor whether a clean room or area meets the cleanliness class required for a particular production process.
Facility Monitoring System (FMS)
The Facility Monitoring Systems (FMS) are designed for continuous monitoring of aerosol particle concentration and other air parameters of the cleanroom working area, archiving and visualization of the obtained data and generation of alarms in case of exceeding the permissible limits of the monitored parameters. Particle concentration control in clean rooms is realized by remote particle counters calibrated according to ISO 21501-4 standard.
Particle counters are integrated into the equipment and installed in the required positions, and isokinetic samplers are brought into the control area. Particle counters located directly in clean areas can be placed in sealed stainless steel boxes for disinfectant treatment. According to the latest revision of Annex1, the length of the sampling tube should not exceed 1 meter. The components of the equipment for clean areas are made of non-toxic, corrosion-resistant materials, without paint coatings, which eliminates the risk of contamination of the product with substances coming from the equipment itself.
In addition to monitoring the concentration of aerosol particles, FMS can record data on air temperature, and relative humidity, differential pressure, laminar flow velocity and other parameters of interest to the customer.
Our solutions are based on the enVigil FMS software package, which is a customizable system and can be fully adapted to customer needs. The enVigil software package is based on compliance with EU-GMP Annex 1, cGMP, GAMP and 21 CFR Part 11 to ensure that the installed system meets current regulatory requirements.
Facility Monitoring System (enVigil FMS)
- Integrated solutions for continuous monitoring of your cleanroom parameters
- 21 CFR Part 11 compliant, ensures secure data management during workflow
- Integrate viable samplers with portables and remote air particle counters Features
- Additional sensors for monitoring microclimate parameters
Compliance
- EU GMP
- Annex 1
- FDA 21
- CFR Part 11
Scalable Solutions
- Small scale, rapidly deployed software and hardware for small production lines
- Combining several production lines into a cluster structure
- Custom solutions for complex monitoring production areas
User interface
- Provides a configurable client interface allowing multi-level mimic displays to be configured
- Color coded alarm indicators of system components
- Alarm acknowledgement is available from a pre-configured comments list and/or free text entry by the user
- Easily created reports in formats:
- Trends
- Historical Reports
- Alarm list
- Audit log
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