Particle Monitoring

ISO 14644 compliance

Classification monitoring by the book

ISO 14644 is not just a one-time test — it requires continuous monitoring to demonstrate that your controlled environment maintains its classification during operation. TERA 360 automates the entire compliance workflow.

ISO 14644-1

Classification verification

Automated sampling per ISO 14644-1 Annex A. The system calculates the required sample volume based on room size and classification level, selects sampling locations per the standard, and determines pass/fail status with 95% upper confidence limits.

Automatic sample volume calculation
UCL 95% statistical analysis
Pass/fail per classification level
Multi-channel counting (0.3 to 10 microns)

ISO 14644-2

Monitoring plan

Define and enforce your monitoring plan per ISO 14644-2. TERA 360 tracks sampling frequency, location coverage, and measurement validity. Any deviation from the plan triggers an automatic notification to the quality manager.

Sampling schedule enforcement
Location coverage tracking
Measurement gap detection
Plan deviation alerts

ISO 14644-3

Test methods reference

Built-in reference data for all ISO 14644-3 test methods. Operators can log supplemental tests (airflow visualization, recovery tests, containment leak tests) and attach them to the room's compliance record.

Test method documentation library
Supplemental test logging
Photo and video attachment
Cross-reference with classification data

TERA 360 real-time particle count dashboard for a cleanroom

Real-time particle counting

Every particle, every second

TERA 360 connects natively to the SafyrOPC particle counter and ePMDUCT duct-mounted sensor, and supports OPCs from all major manufacturers. Live counts display on operator dashboards with sub-5-second latency.

Size channels — Simultaneous counting at 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 microns. Additional channels configurable for specific counter models.
Concentration display — Particles per cubic meter (particles/m3) with automatic unit conversion. Running averages and instantaneous readings side by side.
Threshold coloring — Green when within classification limits, amber at warning level (e.g., 75% of limit), red on excursion. Color coding updates in real time across all widgets.
Multi-counter aggregation — Combine readings from multiple counters in the same room to get a representative room-level measurement. Weighted averages based on sampling flow rate.

Excursion management

Classification tracking and excursion response

Knowing your current particle count is necessary but not sufficient. What matters is whether the room is in spec, how often it drifts, and how quickly you recover.

Live classification status

Each monitored room displays its current ISO classification status in real time. The system evaluates particle counts against the classification limits continuously — not just during scheduled tests — so operators always know where they stand.

Real-time ISO class evaluation (ISO 1 – ISO 9)
At-rest vs. operational state distinction
Time-in-class percentage tracking
Historical classification timeline

Excursion detection

When particle counts exceed classification limits, TERA 360 immediately fires an excursion alert and starts recording the event. The system captures the start time, peak concentration, duration, and contributing factors.

Automatic excursion start/end detection
Peak concentration and duration recording
Correlated parameter capture (door openings, HVAC events)
Excursion severity classification

Recovery tracking

After an excursion, the system tracks recovery time — how long until the room returns to classification. This metric is critical for operating rooms where surgical procedures may need to be delayed until recovery is confirmed.

Recovery time measurement (to 90% and 100%)
Recovery curve visualization
Historical recovery time trending
Automatic "room ready" notification

Root cause analysis

Every excursion record includes a timeline of correlated events: door sensor data, HVAC status changes, personnel count, differential pressure fluctuations. Quality managers can annotate root causes and link corrective actions.

Multi-parameter event timeline
Root cause annotation and categorization
Corrective action tracking (CAPA integration)
Recurring excursion pattern analysis

Applications

Where particle monitoring matters most

Healthcare

Operating rooms

Continuous particle monitoring during surgical procedures. TERA 360 tracks ISO 5 / ISO 7 compliance in real time, correlates excursions with door openings and personnel movement, and provides recovery confirmation before the next procedure begins. Integrated with hospital BMS for automatic HVAC response.

Pharma / Biotech

Cleanrooms

GMP-grade monitoring for pharmaceutical manufacturing. Supports EU GMP Annex 1 requirements with continuous monitoring in Grade A-D zones. Automatic batch record integration, environmental trend reports, and alert acknowledgment workflows designed for validated environments (21 CFR Part 11 compatible).

Particle monitoring