This is the record for the installed HEPA filter leak test, which checks the filter as mounted, including the frame seal and gasket, not the filter medium’s factory efficiency. Replace every <<FILL: ...>> placeholder and keep the field definitions with the record. A filled specimen follows. This content is educational and general; adapt it to your own quality system and confirm the method against the current standard.
Section A: test identity
| Field | Entry | Definition |
|---|---|---|
| Room / area ID | <<FILL>> | Where the filter is installed |
| Filter ID / position | <<FILL>> | Unique filter location |
| Filter class | <<FILL: e.g. H14>> | Manufacturer efficiency class (EN 1822) |
| Test date | <<FILL>> | |
| Reason for test | <<FILL: periodic / post-disturbance / new install>> | |
| Method reference | <<FILL: ISO 14644-3 installed leak test>> |
Section B: instruments and conditions
| Field | Entry |
|---|---|
| Aerosol generator / challenge agent | <<FILL: e.g. PAO / DEHS>> |
| Photometer (or discrete counter) ID, calibration due | <<FILL>> |
| Airflow velocity at test | <<FILL: must be the qualified velocity>> |
| Scan probe-to-filter distance | <<FILL: e.g. ~25 mm>> |
| Scan rate | <<FILL: per the method>> |
Section C: challenge and acceptance
| Field | Entry | Definition |
|---|---|---|
| Upstream challenge concentration | <<FILL>> | Must be recorded, or penetration cannot be calculated |
| Upstream concentration within the method range | Yes / No | Too low invalidates the scan |
| Penetration acceptance limit | <<FILL: conventionally 0.01% for a scan test>> | No point may exceed this |
Section D: scan result
| Field | Entry |
|---|---|
| Full filter face scanned in overlapping strokes | Yes / No |
| Frame seal / gasket perimeter scanned | Yes / No (the most common real leak location) |
| Maximum penetration observed | <<FILL: %>> |
| Result | Pass / Fail |
Section E: leaks, repair, and retest
| Leak location | Penetration % | Repair action | Retest penetration % | Retest P/F |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: re-seat / re-seal / replace>> | <<FILL>> | <<FILL>> |
A leak is repaired and retested; it is not “passed” by re-reading without repair.
Section F: sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Tester | <<FILL>> | ||
| Reviewed (QA) | <<FILL>> | ||
| Next test due | <<FILL: typically every 6-12 months for critical filters>> |
References
ISO 14644-3:2019 (installed filter system leakage test). EU GMP Annex 1 (2022). EN 1822 (filter classification, factory efficiency).
Describe these standards by number and title; do not paste their clauses.
Filled specimen
| Field | Entry |
|---|---|
| Filter ID / position | HEPA-A-07, Grade A ceiling, filling zone |
| Filter class | H14 |
| Challenge agent | PAO |
| Upstream concentration | recorded, within method range |
| Acceptance limit | no point above 0.01% penetration |
| Frame seal scanned | Yes |
| Maximum penetration observed | 0.018% at the downstream frame seal, north corner |
| Result | Fail on first scan |
| Repair | Gasket re-seated |
| Retest penetration | 0.004% |
| Retest result | Pass |
The specimen shows the two points inspectors test: the frame seal was scanned (where the leak actually was), and the leak was repaired and retested rather than re-read to a pass.
Common inspection findings this form prevents
- Filter efficiency certification presented as if it were the installed leak test.
- The frame seal not scanned, so the most common real leak is missed.
- Upstream challenge concentration not recorded, so penetration cannot be calculated.
- A leak “passed” by re-reading without any repair.
- The test overdue, or run at the wrong airflow velocity.
How to adapt this form
- Set the acceptance limit and scan parameters from your method and the current standard.
- Record the upstream concentration every time; it is not optional.
- Add a filter map so each position has a traceable ID.
- Set the retest interval from filter criticality and your requalification schedule.
- File the record with the room’s qualification and requalification package.