ISO14644-1 Certified Airborne Particle Counter Real Time Monitoring For GMP Cleanroom

Deploy our 0.1 CFM laser particle counter and FMS (Facility Monitoring System) to provide continuous, validated proof that your cleanroom meets GMP Grade A-D particle limits. This system simultaneously detects 0.5 µm and 5.0 µm particles with zero false counts, logging data directly to a secure, 21 CFR Part 11 compliant database. As an integrated solution, it drives alarm beacons, prints real-time batch reports, and auto-calculates ISO 14644-1 classes. Reduce your reliance on manual settle plates and provide paperless, defensible data for every sterile batch release.

Manual particle monitoring introduces errors: you sample only a fraction of the production time, miss critical excursions, and waste operators’ time. Regulatory bodies now expect continuous monitoring for Grade A zones under EU GMP Annex 1 (2022), citing data integrity requirements. If your batch record lacks continuous particle data during filling, an auditor may invalidate the entire batch. Traditional counters also generate alarms that operators dismiss without documented investigation. You face a real risk of 483 observations for incomplete environmental monitoring, data integrity gaps, or unprotected recipe-based reports.

Our monitoring system places isokinetic probes at every critical location — filling needle, stopper bowl, and exit tracks. Each sensor connects to a central FMS controller, which collects 1-minute sample counts and displays live trends on a touchscreen panel in the supervisory corridor. When counts exceed alert/action limits (e.g., ≥100 counts/m³ of ≥0.5 µm), the system triggers visual stack lights and sends SMS/email alarms. The audit trail records every login, alarm acknowledgment, and parameter change. Batch reporting is automatic: at the end of filling, press one button to generate a PDF report with all particle, temperature, RH, and differential pressure data.

• Aseptic vial filling isolator continuous monitoring
• Blow-fill-seal (BFS) machine critical zones
• Sterile compounding pharmacy Grade A hoods
• Cleanroom classification and annual requalification
• Filter integrity test for HEPA housing (scanning)
• Clean area equipment qualification (IQ/OQ)

A vacuum pump pulls a precisely 28.3 LPM sample through the isokinetic probe. The sample stream passes through a laser diode cavity; a photodetector registers scattered light pulses as particles cross the beam. Pulse height determines size; the onboard firmware assigns each pulse to a channel. Data is sent via Ethernet to the FMS software where it is logged, time-stamped, and compared to user-defined limits. When a threshold breach occurs, the FMS immediately marks affected time-stamps and requests operator comments via a pop-up, enforcing a documented response.

Determine the number of monitoring points based on your risk assessment (typically 10–15 points for a filling line). Choose the flow rate: 1 CFM for Grade A real-time monitoring, 0.1 CFM for transportable classification. Check if integration with existing BMS or SCADA is required; our system offers OPC UA. Request a trial with your worst-case vial size to ensure no interference from glass shards. We offer a free site walkthrough to create a sensor location map in compliance with ISO 14644-1 sampling requirements.

Q1: How often do you calibrate the sensors?

A: Annual OEM calibration with NIST-traceable spheres, compliant with ISO 21501-4. We provide a loaner sensor to avoid downtime.

Q2: What happens to data during a network outage?

A: Each sensor has 2 GB of local buffer memory, storing up to 6,000 records and automatically syncing when the network is restored.

Q3: Is it possible to integrate particle data with my batch record system?

A: Yes, via REST API or direct SQL query; batch traceability is fully supported.

Q4: How do you handle false alarms from cleaning solvents?

A: We configure a “cleaning" mode via a key switch that temporarily mutes alarms while logging the activity as a known event — keeping your audit trail clean.