Cleanroom Testing and Validation

Cleanroom testing proves that a controlled environment meets its ISO class: the right particle count, airflow, air change rate, pressure cascade, temperature and humidity. TABCOMM tests and validates cleanrooms, operating theatres, isolation rooms and pharmaceutical areas to ISO 14644.

Testing, Adjusting and Balancing

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In a Cleanroom, Air Quality Is the Product

In an operating theatre, a pharmacy compounding room or a production cleanroom, a failed HEPA filter or a reversed pressure cascade is not a comfort issue. It is an infection risk, a failed batch or a failed audit. Validation gives you documented proof that the room performs as classified.

Cleanroom Tests

Test	What it proves
HEPA filter integrity (leak) test	Filters and seals are not bypassing unfiltered air
Airflow velocity and volume	Supply air meets design at each filter
Air changes per hour (ACH)	The room is diluted and flushed at the required rate
Differential pressure	Air moves from clean to less clean areas, as designed
Particle count and classification	The room meets its ISO 14644-1 class
Recovery test	The room returns to its class quickly after contamination
Airflow visualisation (smoke test)	Airflow patterns protect the critical zone
Temperature and humidity mapping	Conditions are stable across the room
Room pressurisation verification	Pressure regime holds with doors operating

Typical Facilities

Operating theatres and ICUs · Isolation rooms (positive and negative pressure) · Hospital pharmacies and compounding areas · Pharmaceutical and GMP production · Laboratories · Electronics and controlled manufacturing

How We Validate Cleanrooms

Requirements review. ISO class, design airflows, pressure regime and acceptance criteria confirmed.
Installation qualification. HVAC, HEPA housings and controls checked against design.
All tests carried out at rest or in operation, as specified, with calibrated instruments.
Report and certification. Results, classification and any corrective actions documented for your quality file.

Our validation lead is experienced in URS, FAT, SAT, IQ, OQ and PQ documentation for GMP regulated environments.

Standards We Follow

ISO 14644-1 and ISO 14644-3, NEBB Procedural Standards for Certified Testing of Cleanrooms, ASHRAE 170 for healthcare ventilation, and GMP requirements where applicable.

What You Receive

Cleanroom test report with ISO classification · HEPA integrity test results · Pressure, ACH and particle count records · Instrument calibration certificates · Deficiency list and retest records

Cleanroom Testing FAQ

Do you have any question?

1. What is ISO 14644?

ISO 14644 is the international standard for cleanrooms and controlled environments. Part 1 sets the cleanliness classes by particle concentration, and Part 3 describes the test methods.

2. How often should a cleanroom be tested?

At handover, and then at regular intervals set by the facility’s risk assessment, ISO 14644-2 and any regulator. Many healthcare and pharma facilities retest at least once a year.

3. Do operating theatres need cleanroom testing?

Yes. Operating theatres depend on filtered air, high air change rates and a correct pressure cascade. Testing verifies all three before the theatre is used.