Cleanroom Monitoring
Cleanroom environment, LAF and door interlock monitoring with GMP-ready records
A cleanroom monitoring and control system that tracks temperature, humidity, differential pressure, particle counts and HEPA filter condition, interlocks airlock doors and keeps 21 CFR Part 11 records for pharmaceutical and life-sciences manufacturing sites.
Last updated:
ROOMS · DIFFERENTIAL PRESSURE / TEMP / RH
Filling A
15Pa
21.4°C · 45%
Filling B
14Pa
21.8°C · 47%
Buffer
11Pa
22.1°C · 49%
Change rm
8Pa
22.6°C · 52%
Corridor
6Pa
22.9°C · 50%
Wash
12Pa
23.0°C · 55%
TREND · FILLING A · DP24 h
AUDIT TRAIL · 21 CFR PART 11READ-ONLY
| 10:42:18 | DP high SP · Filling A | 18 → 17 Pa |
| 10:41:55 | Alarm ack · Change rm | DP warning |
| 09:03:07 | Report signed · Daily EMS |
What the system does
A cleanroom stays compliant only if its pressure cascade, temperature, humidity and particle levels stay within limits every minute, and if the records prove it. Paper logs and standalone recorders leave gaps that auditors find.
We engineer the full cleanroom layer: the environmental monitoring system (EMS), LAF monitoring, AHU control through DDC and VFD panels, door interlocks for airlocks and stainless steel cleanroom hardware. All of it reports into one validated system with alarms, trends and signed reports.
The work is designed against cGMP, WHO GMP, EU GMP, EU Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+ data integrity principles, which are also the expectations applied in PIC/S inspections.
- 01
Environmental monitoring (EMS)
Continuous monitoring of temperature, relative humidity, room-to-room differential pressure and particle counts, with high, low and warning limits per room.
- 02
LAF monitoring
HEPA filter differential pressure for each LAF unit with high and low limits that signal when a filter needs replacing, plus temperature and humidity at the unit, for ISO Class 5 and 7 clean air zones.
- 03
Door interlock system
Airlock doors are interlocked so one cannot open until the other is closed, protecting the pressure cascade. Supports restricted entry and exit, secure entry with free egress, and an audit trail of every access.
- 04
AHU control through BMS
DDC panels with analogue and digital I/O modules, HMI and BACnet or Modbus communication, plus VFD panels with bypass switch and harmonic filters. Points include return air temperature and RH, G4/F7/F9 filter DP, blower DP, valve positions and VFD status.
- 05
Alarms, trends and signed reports
Alarm reports with generated, normalised and acknowledged times, per-minute data reports and trend reports with min/max, all as PDF with user and QA review blocks.
- 06
21 CFR Part 11 data integrity
Electronic records and signatures, role-based access, double signature on setpoint changes and a non-editable audit trail of every change.
- 07
Cleanroom-grade hardware
Stainless steel flush-mount monitors, IP65 stainless keyboards, IP65/IP66 tablets with Wi-Fi or PoE, flush signal towers, hands-free intercoms, cleanroom clocks and glove-operable panel PCs.
Across the automation layers
What the solution does at each layer of your facility.
L1 · Field
Installs temperature and humidity transmitters, differential pressure sensors, particle counters, door limit switches and the cabling and trays that connect them.
L2 · Control
Provides DDC and PLC panels for AHUs and door interlocks, and VFD panels with bypass and harmonic filtering for supply fans.
L3 · Supervision
Runs the EMS screens, setpoint screens with high, low and warning limits, alarm handling and historian for every room and LAF unit.
L4 · Enterprise
Produces signed PDF data, alarm, event, audit and trend reports and the audit trail that QA presents during inspections.
Scope and specification
| Item | Scope | Reference |
|---|---|---|
| Room environment | Temperature, relative humidity, particle count | EU GMP, WHO GMP |
| Pressure cascade | Differential pressure between rooms for containment | cGMP |
| LAF units | HEPA filter DP with high/low limits, temperature, humidity | ISO Class 5/7, HEPA/ULPA |
| AHU points | Return air temp/RH, G4/F7/F9 filter DP, blower DP, supply/mix air temp, CHW/HW valve %, VFD frequency/run/trip, fire damper, local/remote, auto/manual | BACnet, Modbus, RS-485 |
| Door interlocks | Airlock interlocking, restricted entry/exit, secure entry with free egress, access audit trail | cGMP |
| Setpoints | High, low, warning-high and warning-low limits, double signature to change | 21 CFR Part 11 |
| Records | Electronic records, electronic signatures, audit trail, role-based access | 21 CFR Part 11, EU Annex 11, ALCOA+ |
| Reports | Data (per-minute), alarm, event, audit and trend reports in PDF | 21 CFR Part 11 |
| Validation | URS, FS, DS, IQ, OQ, PQ, traceability matrix, risk assessment | GAMP 5 |
What it means for operations
Sectors served
- Excursions caught as they happenWarning limits raise an alert before a room or LAF unit reaches its action limit, so operators act before a batch is at risk.
- Pressure cascade protectedDoor interlocks and differential pressure monitoring keep containment intact as people and materials move between grades.
- Filter changes on evidenceHEPA differential pressure trends show when a filter is loading, so replacement is planned rather than reactive.
- Inspections backed by recordsSigned reports and a complete audit trail are available on demand for QA and regulatory inspections.
Frequently asked questions
Can you add monitoring to an existing cleanroom without stopping production?
In most cases, yes. Sensors and transmitters are installed room by room and the system is commissioned in stages, with work sequenced around your production and cleaning schedule. We agree the sequence with your QA and engineering teams during the site assessment.
Which regulations is the system designed for?
We design to cGMP, WHO GMP, EU GMP, EU Annex 11, 21 CFR Part 11 and GAMP 5, with data handled according to ALCOA+ principles. These are the same expectations used in PIC/S inspections, which apply to manufacturers supplying the Saudi market.
Do you provide validation documentation?
Yes. We supply URS, FS, DS, IQ, OQ and PQ protocols, a traceability matrix, risk assessment and a validation summary report, and we support execution of the qualification on site.
How does the door interlock work with emergency exit?
The interlock prevents both airlock doors from opening at the same time during normal operation. It can be configured for secure entry with free egress, so personnel can always leave, and every access event is recorded in the audit trail.
Can the cleanroom system feed a site-wide monitoring platform?
Yes. The EMS, LAF and AHU data can report into our centralised monitoring platform alongside water systems, compressed air, HVAC and production machines, sharing one audit trail and report format.
Let’s start by understanding your facility
Send us a short description of the site and its current systems, and an engineer will come back with clear next steps.