MET ONE air particle counters are industry leaders in providing solutions for Cleanroom Classification and Routine Environmental Monitoring of air cleanliness, adhering to ISO 14644-1, ISO 21501-4, FDA CGMP, and EU GMP Annex 1 standards. Each model boasts a compact design with customizable sizing, flow rates, and communication options, catering specifically to the unique requirements of pharmaceutical cleanroom environments.
With our portable particle counters, users can upload their routine environmental monitoring SOP sampling map and configuration for each location directly into the counters. This transforms the SOP into an interactive sampling map displayed on the counter screen, facilitating daily sampling, reducing training requirements, and minimizing data errors and omissions. This model allows multiple devices to seamlessly interconnect, facilitating secure and compliant configuration and sample data sharing. Incorporating this feature not only enhances the overall security of the particle counter but also eases the workload on the IT department by providing a reliable and validated networking solution.
Our remote particle counters, featuring integrated multi-parameter measurements, help minimize initial installation costs. These models have an open architecture design to communicate seamlessly with your system and can integrate easily with any facility monitoring system. These counters are renowned for their reliability, durability, and seamless integration into 21 CFR Part 11 compliant workflows.
The handheld particle counters facilitate easy ISO Class 5 to 7 monitoring in hard-to-reach places. Lightweight with a high-resolution display, these handheld counters are ideal for the routine monitoring of controlled and mini environments. They are also perfect for easy filter leak troubleshooting for particle-contamination issues, spot-checking critical areas, and targeting particle generation within process equipment.
Our scalable Facility Monitoring Systems (FMS) are adaptable and cater to diverse cleanroom management requirements across various industries, including pharmaceutical production. We provide comprehensive services for designing and installing your particle-counting facility monitoring system. These include project management, system definition and design, software customization, validation processes, and expert installation services.
Features
Essential features of our Air Particle Counters
Portable Particle Counters:
- Multiple devices can seamlessly interconnect, facilitating secure and compliant configuration and sample data sharing.
- Enable users to upload routine environmental monitoring SOP sampling maps and configurations directly into the counters.
- Access remotely via a web browser; features such as review/approve workflow, SOP version control, and electronic record export are all in the counter – no external software is needed.
- A secure, onboard searchable/filterable Audit Trail provides fast reporting during audits, combined with Microsoft Active Directory for Username and Password control for log-on and electronic signatures to support 21 CFR Part 11 compliance.
Remote Particle Counters:
- Count alarm and alerts enable visual notification via built-in status lights.
- Open architecture design to communicate seamlessly with your system; easily integrate with any facility monitoring system.
- Optional relative humidity and temperature probe integrates RH/T data with particle count data in the same data stream.
Handheld Particle Counters:
- Facilitate easy ISO Class 5 to 7 monitoring in hard-to-reach places.
- Lightweight with a high-resolution display.
- On-the-spot process profiling for fast particle event tracking.
Facility Monitoring Systems (FMS):
- Adaptable to diverse cleanroom management requirements across various industries, including pharmaceutical production.
- Trigger prompt responses on the production line through stack lights, audible alarms, and process shutdown signals in the event of an excursion.
- User-friendly interfaces enhance ease of use and reduce the likelihood of human errors associated with manual SOP monitoring.
With these features, MET ONE air particle counters provide reliable and efficient solutions for maintaining cleanroom standards and compliance in pharmaceutical and other cleanroom environments.
Applications
Applications of Air Particle Counters
- Cleanroom classification
- Routine environmental monitoring of controlled- and mini-environments
- Filter leak troubleshooting
- Spot-checking critical areas
- Targeting particle generation within process equipment
- Flow bench validation