Room classification, airflow and pressure cascades proven room by room before release
Commissioning, qualification and validation software for cleanrooms and HVAC where every room, air handling unit and pressure cascade has to be classified and qualified before manufacturing can occupy the space.
A GMP facility's cleanroom envelope is a system in its own right: air handling units, HEPA filtration, pressure cascades, temperature and humidity control, and the rooms themselves all have to be commissioned, qualified and classified to ISO 14644 and EU GMP grade requirements before any manufacturing activity begins. Deskely holds every room, AHU and pressure zone in one register with IQ, OQ, PQ and ongoing environmental monitoring gates built in.
- Assets
- AHUs, HEPA filters, rooms, pressure cascades
- Test
- IQ, OQ, PQ, particle counts, recovery testing
- Environment
- ISO 14644, EU GMP grade A/B/C/D
- Gate
- Room release to manufacturing
Choose your project type
The problem
Forty rooms, a dozen air handling units and a pressure cascade, and a spreadsheet cannot show which room is actually holding classification today.
A cleanroom envelope covers dozens of rooms fed by a smaller number of shared air handling units, with a pressure cascade designed to prevent cross-contamination between grades, all commissioned by an HVAC contractor on a different schedule to the process equipment inside the rooms.
When AHU commissioning data, HEPA integrity test certificates and room classification reports sit in separate contractor and quality files, nobody can confirm which specific room is actually holding its designed pressure differential and particle count today.
Deskely tags every AHU, HEPA filter, room and pressure differential point individually, so classification status is reported room by room instead of assumed from a single HVAC contractor sign-off.
Setting up the register
AHUs, rooms and pressure cascades are tagged assets matched to the room data sheet and HVAC design.
Room data sheets, HVAC schematics and filter schedules are parsed into a reviewed register, so every AHU, HEPA filter and room carries its design grade, its air change rate specification and its pressure differential target from day one.
IQ, OQ and PQ protocols for HVAC systems and rooms are templated once per grade classification and instantiated across every room in the facility, from grade D corridors to grade B core suites.
Ongoing environmental monitoring — viable and non-viable particle counts, temperature, humidity and pressure trending — is held against the same room tag used during qualification, so drift is visible against the original baseline.
Execution
HEPA integrity, airflow visualisation and room classification are proven room by room before any room is released to manufacturing.
HEPA filter integrity is tested (DOP/PAO scan) at each filter, airflow velocity and uniformity are verified per room, and recovery testing confirms the room returns to its classified state within the required time after a disturbance.
Pressure cascade verification confirms every adjacent room pair holds its designed differential under all door and equipment states, with results logged against the specific room-to-room interface rather than a facility-wide statement.
Non-viable particle counts at rest and in operation, and airflow visualisation (smoke) studies for critical zones, are captured against the room and its classification grade, with any excursion logged as a finding against that specific room.
Room release and ongoing environmental monitoring
A room is released to manufacturing from its own signed classification record, not a facility-wide HVAC commissioning certificate.
Room release draws on the specific room's IQ, OQ and PQ status, its pressure cascade verification and its particle count results, so a quality unit can release rooms individually as they complete rather than waiting for the whole facility.
The handover pack for facilities and quality includes as-built room data sheets, HVAC qualification summaries and environmental monitoring baselines keyed to each room, giving the operating team the exact record used to classify it.
Every signature carries a name, role and timestamp, which is what a quality unit and an inspector reviewing a facility's environmental monitoring programme expect before a room is trusted for GMP manufacturing.
Filter change and shutdown requalification
A HEPA filter change or an unplanned HVAC shutdown resets the classification clock on a room, and manufacturing cannot resume there until that is proven, not assumed.
HEPA filters get replaced, AHUs get serviced, and rooms occasionally lose pressure control during a power event or a shutdown. Each of those events is a trigger for requalification of the affected room, but the trigger is only useful if it is actually connected to the room's classification record rather than logged separately as a maintenance event.
On a paper-based programme, a filter change ticket closes in the facilities system while the room's classification certificate sits untouched in the quality system, so a room can be returned to manufacturing use on the strength of a completed maintenance job with nobody checking whether recovery testing and particle counts were repeated.
Deskely flags any room whose AHU, HEPA filter or pressure control system has had a qualifying event, and holds that room from manufacturing release until recovery testing, particle counts and pressure cascade verification are re-run and signed against the room's own tag, so a filter change cannot silently outrun its requalification.
The classification dossier
The evidence an inspector expects to see before a cleanroom is signed off for GMP use.
A cleanroom is only as good as the HVAC system holding its pressure cascade and filtration, and the classification claim rests entirely on measured data. The dossier ties airflow, filter and pressure evidence to the ISO 14644 test results that support the room's stated grade at rest and in operation.
HEPA filter installation leak test reports
Terminal filters are correctly seated with no bypass at the design flow rate.
Before classification testing begins.
Airflow velocity and air change rate verification records
Unidirectional and turbulent flow zones achieve the velocities and change rates specified for the grade.
Commissioning and scheduled requalification.
Non-viable particle count reports (ISO 14644-1)
The room meets its classification limit at rest, in operation and during recovery.
Initial classification and periodic monitoring.
Recovery test results
The room returns to its at-rest particle limit within the time allowed after a contamination event.
Classification testing and after significant HVAC intervention.
Room pressure cascade and differential pressure mapping reports
Air moves from clean to less-clean areas as designed, preventing ingress of contamination.
Commissioning, requalification and continuous monitoring.
Temperature and humidity mapping reports
Environmental conditions stay within the range needed for product stability and operator comfort.
Qualification and seasonal requalification.
How it runs
From AHU FAT to room-by-room release.
Cleanroom programmes reward a register that treats every room as its own qualified asset, because a single room out of grade is what a routine environmental monitoring excursion is designed to catch.
- 01
Model the envelope by room
AHUs, HEPA filters, rooms and pressure cascades modelled as assets tied to the room data sheet and HVAC design.
- 02
Parse HVAC and room documents
Room data sheets and HVAC schematics drafted into a reviewed register with grade and pressure targets attached.
- 03
Template qualification by grade
IQ/OQ/PQ protocols defined once per grade classification, instantiated across every room in the facility.
- 04
Gate release on room-level evidence
Room release to manufacturing reported from that room's own classification and environmental monitoring baseline.
FAQ
Questions about Cleanrooms and HVAC scopes.
Keep reading
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The full sector view: CQV strategy, the validation master plan and the terminology behind them.
Read moreWalkdowns
Pre-qualification walkdowns and cleanroom classification checks run as structured walks that raise punch on the spot.
Read moreCertificates
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