SCOPE
Validation support
Cleanroom validation in Malaysia is what your auditor reads. We plan the tests and prepare the documentation; accredited testing is carried out by an independent party.
Included
- Test plan against ISO 14644-1 and 14644-3
- Particle count, recovery and pressure test scheduling
- Airflow and filter integrity coordination
- Documentation pack for audit
- Requalification interval planning
Test planning belongs in the design stage, not the handover stage. What you have to demonstrate at the end determines what has to be built in at the start, particularly sampling access and monitoring points.
The tests that decide the classification
ISO 14644-1 classification rests on airborne particle counts at defined sample locations. The rest of the test set either supports that result or is required by your regulator.
- Airborne particle count. The classification test itself. Sample locations and minimum sample volume follow from the room area and the target class.
- Airflow volume and velocity. Supply volume room by room, and velocity where unidirectional flow applies.
- Pressure differential. Between adjacent spaces, in the direction the cascade requires, at rest and in operation.
- Installed filter leak testing. At the filter face and at the seal. This is a different test from the particle count and it fails for different reasons.
- Recovery and containment. Recovery time after a challenge, and containment leak testing between graded areas where the regulatory route requires it.
Testing is carried out by an independent party. We plan the test set, prepare the documentation and coordinate the schedule, which keeps the party that builds the room separate from the party that certifies it.
Classification certification
Certification of a cleanroom's classification is issued by the independent party that carries out the testing, not by whoever built the room. We prepare the documentation the testing runs against, and we hold the records your auditor will ask for.
What we need from you
- Room classification and layout
- Regulatory route and auditor expectations
- Previous qualification records, if any