Guide
Cleanroom validation to ISO 14644 – measurements and documentation
Validation is the proof that a cleanroom holds its class. We measure, document and deliver evidence that stands up in an audit – both for new builds and as recurring control.
What does a cleanroom validation include?
A full validation covers several measurements that together show the cleanroom meets its specified class, both at rest and in operation.
Particle counting to ISO 14644-1 with a calibrated particle counter.
Air flows and air change rates per room and filter.
Pressure differentials between zones and verification of the pressure cascade.
Recovery time – how quickly the room returns to class after a disturbance.
Filter integrity testing (DOP/PAO) of HEPA filters and their seals.
When required: temperature, relative humidity, noise level and lighting.
At rest or in operation?
ISO 14644 distinguishes between as-built, at-rest and operational. The difference matters: a room can hold class 7 at rest but fail in operation if staff flows and equipment generate more particles than calculated. We always recommend measuring in the state that reflects your real production.
How often should you revalidate?
Common practice is annual revalidation for ISO class 6–8 and every six months for class 5, plus always after rebuilds, filter changes or process changes. With a service agreement we plan the measurements so you are never behind before an audit.
Documentation that holds up in an audit
You receive reports with measured values, instrument calibration certificates, deviations and proposed actions. When needed we link the results to your qualification (IQ, OQ, PQ) and bring in third-party validation.
Need validation or revalidation?
Get in touch and we will come back with scope, timeline and price for the testing.