ServiceA-02.04
Testing & Qualification
The measurements that prove a room performs: HEPA integrity, velocity, air changes, differential pressure and the IQ/OQ/PQ documentation behind them.
Engineering approach
How we work on this
The order matters more than any individual decision in it. Most of the failures we are called in to correct are sequencing failures rather than equipment failures.
- 01
Balance first, then test
Testing an unbalanced system measures the installation error rather than the design. Air balancing comes first, so that the numbers recorded afterwards are the numbers the room will actually hold.
- 02
One protocol, in order
Installation, operational and performance qualification run in sequence and each closes before the next opens. A performance result taken on an installation that was never formally verified cannot be defended in an audit.
- 03
Recorded so it can be re-checked
Every reading is recorded against a location, an instrument and a date. Re-qualification later is a comparison against that record, which is only possible if the first set was captured properly.
Scope of workA-02.04
Everything carried under this discipline
Not a summary. If it is on this list we carry it ourselves rather than subcontracting it.
- 04.01HEPA integrity testing
- 04.02Air velocity measurement
- 04.03Air changes/hour verification
- 04.04Differential pressure testing
- 04.05Temperature & RH monitoring
- 04.06Particle-count coordination
- 04.07Air balancing
- 04.08IQ/OQ/PQ documentation
Deliverables
What you are holding at the end
The documents that make the next stage of your project possible, and that an auditor will ask to see.
- Air balancing report with measured volumes
- HEPA integrity test certificates
- Air velocity and air-change verification record
- Differential pressure and cascade record
- Temperature and relative humidity record
- IQ/OQ/PQ protocol and executed documentation
Relevant standards
What the work is designed and tested to
- ISO 14644-1
- Cleanroom classification by airborne particle count
- WHO-GMP
- Good manufacturing practice for pharmaceutical premises
- USFDA
- US requirements for drug manufacturing facilities
Typical applications
Where this work goes
- New cleanroom and OT handover
- Periodic re-qualification of classified areas
- Pre-audit verification
- Investigating rooms that have stopped meeting class
Proof
Work of this kind
Most of our work is carried out under confidentiality agreements with pharmaceutical manufacturers and hospitals, so it is not published here. Reference contacts for comparable facilities are provided on request during a tender.
Questions
What people ask us first
- Do you do particle counting yourselves?
- Particle counting for classification is coordinated with a calibrated counting service so the certificate comes from an independent instrument. Velocity, air changes, differential pressure, temperature, RH and HEPA integrity are measured by us.
- How often should a classified room be re-qualified?
- Typically every six to twelve months depending on the class and the governing standard, and after any change to the filtration, the plant or the room itself. Filters load and dampers drift; neither trips an alarm.
- Can you qualify a room somebody else built?
- Yes. That is a common request, and it often begins as an investigation into why a room is not holding its class.