Cleanroom Validation, HEPA/ULPA Integrity Testing & Continuous Monitoring
Primionics configures measurement systems for ISO 14644 airborne-particle classification, installed HEPA and ULPA filter-system leakage testing, airflow and pressure verification, recovery studies, airflow visualization and fixed environmental monitoring. Portable qualification instruments, TOPAS aerosol equipment and Kanomax particle and airflow instrumentation are selected around the room class, occupancy state, filter installation, test method and monitoring plan.
Qualification proves performance at a defined condition; monitoring provides evidence between qualification events.
ISO 14644-1 addresses classification of air cleanliness by particle concentration. ISO 14644-3 provides test methods for cleanroom performance, including installed filter-system leakage, airflow and recovery-related tests. ISO 14644-2 addresses the monitoring plan used to provide ongoing evidence of performance related to particle cleanliness.
These activities share instruments and data, but they are not interchangeable. A fixed particle sensor does not by itself perform room classification, and a portable classification counter does not by itself create a complete monitoring system.
Measurement coverage for room classification and installed-system performance.
Airborne-particle classification
Configure sampling locations, sample volume, particle-size channels, occupancy state and report logic for ISO 14644-1 classification.
Installed HEPA/ULPA filter-system leakage
Verify the complete installed filter system using an upstream aerosol challenge and systematic downstream scanning of the filter face and installation interfaces.
Air velocity and air volume
Measure terminal-filter velocity, average velocity, air volume and airflow uniformity with probes or capture methods suited to the diffuser and airflow pattern.
Differential pressure and pressure cascade
Verify room-to-room and room-to-corridor pressure differences, pressure direction, stability and alarm behaviour.
Recovery-time measurement
Introduce a controlled particle challenge and record concentration decay to determine the time required to recover to the specified cleanliness condition.
Airflow visualization
Use visible fog to evaluate airflow direction, unidirectional-flow behaviour, turbulence, dead zones and interaction with equipment or operators.
Temperature and relative humidity
Measure environmental conditions where they form part of the facility specification, process requirement or monitoring plan.
Continuous particle and environmental monitoring
Deploy fixed particle, pressure, temperature and humidity points with trend records, alarms, acknowledgement and integration into the facility data architecture.
The leak test verifies the complete installed filter system—not only the filter media.
Installed filter-system leakage testing checks the filter face together with the frame, gasket or gel seal, mounting arrangement, housing interfaces and accessible bypass paths. The exact aerosol, measurement method and acceptance criterion must follow the applicable test procedure and project specification.
Aerosol generation, dilution, upstream reference and downstream scanning must operate as one traceable method.
A sufficiently strong upstream challenge is needed to detect small local leaks. That concentration can exceed the usable range of a particle counter, making a known dilution ratio necessary for upstream measurement. Downstream scanning then uses the particle counter at its direct measurement range.
The sampling probe, particle-counter flow rate, scan speed, distance from the filter surface and airflow velocity affect the probability of detecting a local leak. The installed system must therefore be tested with a method matched to the filter geometry and airflow condition.
Instrumentation selected for the required particle size, sample volume, airflow range and monitoring architecture.
Kanomax portable particle counters
Portable six-channel particle counters support room classification, investigation and verification at model-specific flow rates and particle-size thresholds.
Select by minimum particle size, sample flow, sample-volume requirement, cleanroom class, data handling and calibration scope.Kanomax 0.1 µm particle measurement
The Model 3950 addresses 0.1 µm and 0.3 µm measurement for high-end contamination-control and semiconductor applications.
Confirm that the required particle size, sample volume, flow rate and classification method are compatible with the project requirement.Kanomax remote particle and environmental monitoring
Remote particle sensors and cleanroom monitoring architecture support fixed measurement points, trends, alarms and connection to facility data systems.
Define critical locations, tubing length, transport loss, sensor response, network interface, redundancy, alarm logic and data retention.TOPAS aerosol generation and dilution
ATM aerosol generators create the challenge aerosol, while DIL systems reduce the upstream concentration into the working range of the particle counter.
Specify aerosol material, generator output, dilution ratio, sample flow, facility exhaust and required operating time.TOPAS cleanroom particle analysis and scanning
Cleanroom particle counters, rectangular sampling probes and CRQWin software support classification, installed filter leakage scanning and structured reporting.
Match counter flow, probe geometry, airflow velocity, scan method and software workflow to the applicable test procedure.Airflow, air-volume and pressure measurement
Thermal anemometers, micromanometers, capture hoods and application-specific probes support terminal velocity, volumetric flow and pressure verification.
Confirm measurement range, uncertainty, probe access, diffuser type, airflow direction and room operating condition.Airflow visualization
Controlled fog generation makes airflow direction, turbulence, recirculation and interaction with equipment or operators visible.
Confirm fog suitability, residue requirements, output duration, visibility, ventilation recovery and recording method.Calibration, verification and records
Calibration certificates, pre-use checks, location plans, raw data, calculations and signed reports form part of the measurement system.
Define calibration interval, as-found/as-left handling, instrument status, user access, audit trail, retention and change control.A monitoring system must be designed around process risk and response—not the number of available sensors.
Qualification and monitoring for contamination-controlled environments.
Pharmaceutical and biotechnology facilities
Support cleanroom qualification, installed-filter integrity testing, environmental investigation and risk-based monitoring for controlled production and laboratories.
Semiconductor and microelectronics cleanrooms
Measure airborne particles down to the required threshold, verify airflow and monitor critical process environments where submicron contamination affects yield.
Medical-device and precision manufacturing
Provide qualification and monitoring evidence for controlled assembly, packaging, inspection and production areas.
Hospitals, operating rooms and controlled clinical areas
Verify airflow direction, pressure relationships, filter-system integrity and particle conditions according to the facility procedure and applicable healthcare requirements.
Cleanroom contractors and validation teams
Configure portable test sets, aerosol equipment, scanning accessories and reporting workflows for commissioning, periodic qualification and troubleshooting.
Research, aerospace and advanced materials
Characterize contamination-controlled spaces used for sensitive experiments, optics, components, materials and high-reliability assembly.
Technical information required to configure the qualification and monitoring system.
Cleanroom qualification and monitoring questions.
What is the difference between classification and monitoring?
Classification is a defined test of airborne particle cleanliness at specified locations and occupancy states. Monitoring follows a risk-based plan and provides evidence of ongoing performance between qualification events.
The same instrument may contribute to both activities, but the sampling plan, data interpretation and evidence are different.What does the HEPA or ULPA integrity test include?
It evaluates the installed filter media, frame, gasket or gel seal, mounting arrangement, housing interface and accessible bypass paths using an upstream challenge and downstream scan.
A filter certificate does not replace testing of the completed installation.Why is an upstream dilution system used?
The challenge concentration needed for reliable leak detection can exceed the particle counter's direct concentration range. A defined dilution system allows the upstream reference to be measured without overloading the counter.
The selected dilution ratio and flow must match the counter and test method.Can fixed particle sensors replace ISO 14644-1 classification?
No. Fixed sensors support the monitoring plan, while classification requires specified sampling locations, sample volumes, occupancy state, instrument suitability and classification calculations.
The monitoring layout should be justified independently from the classification sampling map.