Stage 1
SERVICE / 01Critical Filter Validation
HEPA Terminal Filter Efficiency & Integrity Testing
Verification of installed HEPA and ULPA filters to confirm efficiency, integrity and dependable cleanroom performance.
Arrange a validation visitMeasured
Documented
Documented
Why this test matters
Evidence for confident environmental control.
HEPA filters are central to cleanroom classification. Periodic testing identifies seal leakage, installation damage, clogging and loss of efficiency before these issues compromise a controlled area. The protocol is coordinated with the installed terminal arrangement and applicable facility requirements.
Clear evidence of filter condition and installed-system integrity.
Typical scope
Defined around the room, risk and required evidence.
Testing is normally planned after installation or maintenance, following a filter change, and at the periodic interval defined by the facility quality system.
- Installed HEPA or ULPA terminal filters
- Filter face, perimeter seal and housing interface
- Upstream challenge concentration and downstream scan
- As-found condition and post-correction retest where agreed
A disciplined path from measurement to report.
Stage 2
Introduce the agreed aerosol challenge upstream
Stage 3
Scan the downstream filter face, frame and seals
Stage 4
Record observations, results and required actions
Validation framework
Testing aligned with the operating context.
The final protocol is confirmed against the facility classification, process risk and applicable quality requirements.
- GMP expectations
- ISO 14644 guidance
- Application-specific protocol
Results your engineering and quality teams can use.
Every assignment is structured for review, traceability and practical follow-through.
Approved test protocol and location schedule
Instrument identification and calibration traceability
Filter-by-filter result record
Exception notes and signed validation report
Need a clear validation scope?
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