PMS 31 Remote Particle Counter: A New Choice for Cleanroom Monitoring

by Temtop US on Nov 18, 2025 0 comments

PMS 31 Remote Particle Counter: A New Choice for Cleanroom Monitoring

Introduction

In pharmaceuticals, electronics, and medical devices, airborne cleanliness directly affects product quality and regulatory audits. As global regulations move toward continuous monitoring, data integrity, and risk-based control, Temtop PMS 31 addresses these requirements with standardized flow, industrial reliability, and easy system integration for robust cleanroom monitoring.

From “Spot Checks” to Continuous, In-Operation Monitoring

● Tighter expectations: Non-viable particle (NVP) monitoring, trend analysis, and alarm response are now explicit, with complete data trails for audits.

● Method upgrade: The industry is shifting from static sampling/portable spot checks to continuous monitoring during operation, emphasizing sampling volume, statistical confidence, and response time.

● Data integrity: Electronic records and signatures (access control, audit trails) are becoming baseline requirements so monitoring data are auditable and traceable.

Why the “Standard” Flow Matters

Sampling flow is tightly linked to use cases:

● 2.83 L/min (≈0.1 CFM): Common for portable/spot checks and short-term verification.

● 28.3 L/min (1 CFM): A de-facto standard for classification and routine, in-operation monitoring. At 1 CFM, a one-minute sample yields ~28.3 L, improving statistical confidence in ISO 5 / Grade A/B areas and capturing short spikes faster.

Why 28.3 L/min suits online monitoring

● Higher confidence: Larger per-minute volume increases detection probability at 0.3–0.5 μm where backgrounds are very low.

● Faster response: Short contamination bursts/leaks are more readily detected, reducing risk exposure windows.

● Engineering control: With proper isokinetic probes, tubing design, and flow calibration, high-flow monitoring maintains size accuracy and counting efficiency.

PMS 31: Key Value for B2B Buyers

● Multi-channel sizing: Seven channels from 0.3–10 μm to cover mainstream cleanroom classes.

● Standardized flow: 28.3 L/min (1 CFM) for classification and in-operation monitoring.

● Built-in vacuum source: No external pump needed; faster deployment and scaling.

● Industrial reliability: Long-life laser/optics designed for 24/7 service.

● Compliance-ready: Calibrated to ISO 21501-4 for traceability and instrument-to-instrument consistency; works with enterprise Part 11 processes (access control, audit trails) for auditable data.

● Easy integration: RS485 (Modbus RTU) for EMS/BMS/SCADA connectivity.

Scenario Fit

Pharma (Aseptic/Exposure areas)

● Need: Continuous NVP monitoring, trending, alarms, and traceable records.

● Fit: 28.3 L/min + 0.5/0.3 μm channels; online records for QA release/audits.

Electronics/Semiconductor

● Need: High sensitivity near critical tools and steps; micro-particle control links to yield.

● Fit: 0.3 μm channel + higher volumetric throughput improves detection speed.

Medical Devices

● Need: ISO class compliance and third-party audits with complete evidence chains.

● Fit: Continuous operation + online reporting supports inspections and annual reviews.

Laboratory / QA

● Need: Periodic verification, deviation investigations, and fixed evidence.

● Fit: Built-in vacuum, configurable timing and point strategies; easy drop-in.

Integration & Compliance Checklist

● Instrument–Method–Data Loop:

○ Instrument: ISO 21501-4 calibration (counting efficiency, size accuracy/resolution, repeatability).

○ Method: ISO 14644-1/-2 for point planning, sampling volume, and monitoring strategy.

○ Data: Enterprise Part 11 processes for electronic records/signatures and audit trails.

● Sampling system engineering: Isokinetic probe selection, tubing diameter/length/elbows, routine flow calibration and leak checks to preserve sizing fidelity at high flow.

● Alarms & trending: Baseline modeling, alert/action limits, false-positive control, and escalation matrices to close the loop from alarm → investigation → CAPA → review.

Conclusion

With 28.3 L/min standardized flow, 24/7 reliability, and compliance-minded design, PMS 31 aligns with the global shift to continuous monitoring and data integrity. Whether for new line classification or in-operation monitoring and deviation investigations, it is a cornerstone for building a trustworthy cleanroom monitoring system.