Continuous cleanroom monitoring for ISO 14644 & GMP Annex 1

Automated particle monitoring, excursion management and audit-ready documentation. From pharmaceutical production to microelectronics fabrication.

EU GMP Annex 1 (revised 2023) mandates continuous monitoring with documented evidence of environmental control. ISO 14644-3 specifies sampling frequencies and locations. Handwritten logs, Excel-based tracking and periodic spot checks no longer satisfy regulators — every data gap delays batch release and risks production shutdown.

100 %

Continuous compliance — every sampling point monitored around the clock

21 CFR 11

Electronic signatures, audit trails, tamper-proof storage

85 %

Less manual logging — personnel redirected to analysis and improvement

The challenge

Manual compliance is unsustainable

Regulatory pressure intensifies

FDA 21 CFR Part 11 requires data integrity controls — electronic signatures, audit trails, tamper-proof storage. The bar keeps rising.

Manual logging fails auditors

Data gaps, transcription errors and missing timestamps create audit findings. Each finding delays batch release and risks production shutdown.

Excursion response is reactive

When particle counts exceed limits, how fast do operators know? In many facilities, the answer is "at the next manual check" — which could be hours. Late detection means larger contamination zones, more affected batches, and costlier investigations.

QA workload is unsustainable

Quality assurance teams spend significant time compiling environmental monitoring data for batch records and trend reports. This is repetitive, error-prone work that diverts skilled personnel from higher-value activities.

How TERA 360 works

Continuous monitoring with complete data integrity

TERA 360 automates the entire environmental monitoring workflow — from particle counting to audit-ready reports.

Continuous counting with SafyrOPC

SafyrOPC wireless optical particle counters, designed exclusively for cleanrooms, continuously measure >0.3 um and >0.5 um channels. LoRa communication with the Gateway Pure™. ISO 21501-4 certified. Battery life 12h to 168h. Smooth surface for easy cleaning. Deployed in minutes, no drilling required.

Automated classification

The platform evaluates particle data against ISO 14644-1 classification limits in real time. At-rest and in-operation states are tracked separately. Classification status is always current, always documented.

Excursion management

When counts exceed thresholds, the system triggers immediate alerts with escalation paths. Excursion events are logged with start time, peak values, duration, affected zones and root cause fields. Investigation workflows guide operators through corrective actions.

Sensors & systems

Measurement infrastructure for GMP environments

SafyrOPC — Optical counter

SafyrOPC wireless particle counter, designed exclusively for cleanrooms. ISO 21501-4 certified. LoRa communication with the Gateway Pure™. >0.3 um and >0.5 um channels. 2.83 l/min flow rate. Battery life 12h to 168h. Compact, smooth surface, USB-C. Classes A* to D, ISO 5-7-8. CFR 21 Part 11 and ALCOA+ compliant.

DeltaP sensors (BLE)

Wireless BLE differential pressure sensor. Range +/-500 Pa, accuracy <1 Pa. Battery life up to 5 years. Continuous monitoring of room-to-room and room-to-corridor pressure cascades. Deployed without drilling or cabling.

T/RH, door contacts & presence

Wireless BLE sensors: temperature/humidity (18-year battery life), magnetic door contacts (14.5 years), PIR presence detection (6 years). All communicate with the Gateway Pure™. Essential for correlation analysis during excursions.

CFR 21 / ALCOA+ platform

Cloud platform hosted on OVH France/Europe. 21 CFR Part 11 and ALCOA+ compatible: electronic signatures, audit trails, role-based access, time-stamped records with tamper detection. 99.95% SLA. Made in France.

TERA 360 cleanroom monitoring dashboard with classification status and excursion management

Dashboards & alerts

Real-time visibility for operators and QA

Cleanroom status map — Interactive facility layout showing real-time classification status per zone. Green/yellow/red indicators with current particle counts, DeltaP readings and T/H values. Drill down to any sampling point for historical trends and excursion history.
Excursion dashboard — Centralized view of all active and recent excursions. Each event shows timeline, affected zones, peak values, root cause assignment and CAPA status. Trend analysis identifies recurring patterns — door discipline issues, HEPA degradation, process-related events.
Batch-linked reports — Environmental data automatically linked to production batch records. PDF reports generated per batch, per room, per campaign. Includes statistical summaries, excursion details and classification confirmation — ready for QP release review.
Tiered alert system — Configurable alert thresholds per zone with multi-level escalation: action limits, alert limits, specification limits. Notifications via email, SMS, on-screen and BMS integration. Acknowledgment tracking ensures every alert is addressed.

Benefits

From reactive compliance to proactive control

100 %

Continuous compliance — every sampling point monitored around the clock. Classification status verified against ISO 14644-1 limits in real time. No data gaps, no assumed compliance, no surprises during audits.

85 %

Reduction in manual logging — automated data collection, classification calculations and report generation eliminate the bulk of manual QA work. Personnel are redirected to investigation, root cause analysis and process improvement.

Audit-ready documentation

All data stored with 21 CFR Part 11 compatible integrity controls. Reports generated automatically in formats expected by FDA, EMA and national regulators. Audit preparation time reduced from weeks to hours.

Faster excursion response

Real-time alerts mean operators know about excursions in seconds, not hours. Faster response limits contamination scope, reduces batch risk, and shortens investigation timelines.

100%

Continuous compliance

Data gaps

85%

Less manual logging

21 CFR 11

Compliant

Ready to modernize your cleanroom monitoring?

We'll assess your current monitoring setup, identify gaps, and design a compliant solution.

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