This is a ready-to-use HVAC performance qualification protocol for classified areas. The particle-count class is the headline number, but qualification proves the system that delivers it: filtration, airflow, sweep direction, pressure cascade, recovery, and conditions. This protocol runs the full test set in the order the tests depend on each other. Replace every <<FILL: ...>> placeholder, read numeric limits off the current standards and your URS, and route it through your validation lifecycle. A filled specimen follows. Confirm each cited standard against the current source before you rely on it.
Approval page
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Validation / C&Q) | <<FILL>> | ||
| Reviewer (HVAC / facilities SME) | <<FILL>> | ||
| Reviewer (Microbiology) | <<FILL>> | ||
| Approver (Quality Assurance) | <<FILL>> |
| Field | Entry |
|---|---|
| Protocol number | <<FILL: e.g. PQ-HVAC-001>> |
| Version | <<FILL>> |
| Rooms / suite in scope | <<FILL>> |
| Grades / ISO classes | <<FILL: e.g. Grade B / ISO 7 at rest, ISO 8 in operation>> |
1. Objective
Demonstrate that the HVAC system delivers and maintains the required air cleanliness, airflow, pressure relationships, recovery, and conditions in the rooms in scope, in both at-rest and in-operation occupancy states, per the URS, EU GMP Annex 1, and ISO 14644.
2. Scope
Covers the rooms and air handling in Attachment A. Cleanroom particle classification is performed here per ISO 14644-1; the viable environmental monitoring qualification is covered separately under the environmental monitoring program. Commissioning and TAB are prerequisites, not part of this protocol.
3. Prerequisites
- URS and design qualification approved; room grades and set points defined and justified.
- TAB (test, adjust, balance) complete and documented; the system is balanced to design.
- All instruments calibrated and traceable (particle counter, aerosol photometer, capture hood/anemometer, manometer, thermohygrometer).
- HEPA filters installed; rooms cleaned and ready.
4. Roles
| Role | Responsibility |
|---|---|
| Tester / specialist contractor | Runs each test under this protocol; deliverables reviewed and approved by the site |
| Validation | Owns the protocol, acceptance criteria, and summary |
| QA | Approves protocol, deviations, and report |
| Microbiology / SME | Supports the smoke study interpretation and links to EM |
5. Acceptance criteria (protocol level)
Every test passes its acceptance criterion in every room in scope, in both required occupancy states where applicable, with all deviations closed. Read the numeric limits from the current standards and your URS.
6. Test sequence and cases
Run in this order; each test depends on the previous being settled.
| # | Test | What it proves | Acceptance basis | Result |
|---|---|---|---|---|
| 6.1 | HEPA filter installation integrity (DOP/PAO scan) | Terminal filters, gaskets, and frames have no leaks | <<FILL: e.g. <= 0.01% penetration>> per IEST-RP-CC034 / ISO 14644-3 | <<FILL>> |
| 6.2 | Airflow volume and air changes per hour (ACH) | Enough clean air is delivered | <<FILL: design ACH per room>> | <<FILL>> |
| 6.3 | Air velocity (unidirectional / Grade A) | Laminar sweep clears the critical zone | <<FILL: guidance value from Annex 1; justify set point>> | <<FILL>> |
| 6.4 | Room pressure differentials (cascade) | Cleaner rooms positive to dirtier rooms | <<FILL: e.g. 10 to 15 Pa; justify>> | <<FILL>> |
| 6.5 | Airflow visualization (smoke study), at rest and in operation | Air sweeps clean to less-clean; no ingress or entrainment over open product | Documented video; no adverse behavior | <<FILL>> |
| 6.6 | Particle classification, at rest | Room meets its ISO class / EU Grade at rest | ISO 14644-1 class limits (at rest) | <<FILL>> |
| 6.7 | Particle classification, in operation | Room meets its class / Grade in operation | ISO 14644-1 class limits (in operation) | <<FILL>> |
| 6.8 | Recovery time | Room clears a challenge in a defined time | <<FILL: e.g. <= 15 to 20 min, or 100:1>> per ISO 14644-3 | <<FILL>> |
| 6.9 | Temperature and relative humidity | Conditions met for process, microbial control, comfort | Per URS (<<FILL: e.g. 20 +/- 2 C, RH 30 to 60%>>) | <<FILL>> |
Notes: for Grade A/B critical zones the in-operation smoke study (6.5) is effectively mandatory under Annex 1, video-recorded over every open-product location; both occupancy states (6.6 and 6.7) are required for EU Grades, and reporting only one is a finding.
7. Deviation handling
Record each discrepancy as a numbered deviation, assess impact on the room’s qualified status, resolve, and re-test. QA approves each deviation and the final disposition.
8. Summary and conclusion
| Field | Entry |
|---|---|
| Rooms qualified | <<FILL>> |
| Tests passed / failed | <<FILL>> |
| Deviations raised / closed | <<FILL>> |
| Requalification interval set | <<FILL: per Annex 1 / ISO 14644-2>> |
| Conclusion | <<FILL>> |
| Approved by (QA) | <<FILL: name, signature, date>> |
9. References
ISO 14644-1 (classification), ISO 14644-2 (monitoring/requalification), ISO 14644-3 (test methods). IEST-RP-CC034 (HEPA filter leak testing). EU GMP Annex 1 (2022, effective 25 August 2023); 21 CFR 211.46 (ventilation and air filtration). Related reading: clean utilities qualification, cleanroom classification per ISO 14644, temperature mapping qualification.
Confirm the current version and clause numbers of each reference before issue.
10. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
Filled specimen
The following shows the completed test set for an example Grade C filling support room, so you can see how the two occupancy states and the full test list read. The values are illustrative.
| Parameter | Acceptance criterion | Measured | Verdict |
|---|---|---|---|
| Terminal HEPA integrity | <= 0.01% penetration | max 0.004% | Pass |
| Air changes per hour | >= 20 ACH | 24 ACH | Pass |
| Pressure to adjacent Grade D | 10 to 15 Pa, positive | +14 Pa | Pass |
| Particle class at rest | ISO 7 limits | within limits | Pass |
| Particle class in operation | ISO 8 limits | within limits | Pass |
| Recovery time | <= 20 min to class | 12 min | Pass |
| Temperature | 18 to 22 C | 20.4 C | Pass |
| Relative humidity | 30 to 60% | 48% | Pass |
In this example the room passed in both the at-rest and in-operation states, which is the point an inspector checks first: reporting a classification in only one occupancy state hides the real exposure. The HEPA integrity scan (a leak test of the filter face and frame) is reported separately from the room particle count, because a room-average count can pass while a pinhole leak in one filter goes unseen.
Common inspection findings this protocol prevents
- Smoke study done at rest only, or not recorded over open product in the critical zone.
- Classification reported in one occupancy state instead of both required states.
- Recovery time never tested, so the room cannot be shown to recover after a disturbance.
- HEPA integrity confused with room classification, so a filter leak is never scanned for.
- Pressure cascade verified only with doors closed, ignoring normal door-open working conditions.
How to adapt this protocol
- Set your protocol number, rooms, and grades on the approval page.
- Read the numeric limits (penetration, ACH, velocity, pressure, class limits, recovery, conditions) off the current standards and your URS; justify every set point.
- Record the in-operation smoke study on video for each Grade A/B intervention point and retain it.
- Set the requalification interval per Annex 1 and ISO 14644-2 and record it in the summary.
- Confirm every standard against the current published version before issue.