Precision Cleanroom commissioning
Validation, air balancing and commissioning that prove your cleanroom meets its ISO 14644 cleanliness class.
Cleanroom validation and commissioning confirm that your controlled environment performs to its specified cleanliness class before it enters service, and continues to hold that standard once it is running. Clean Ducts’ cleanroom engineers carry out air balancing, filter integrity testing and full documentation against ISO 14644 and Good Manufacturing Practice (GMP) requirements.
Validation, air balancing and commissioning are the processes that prove a cleanroom meets its specified standards, regulations and performance criteria. Our cleanroom validation engineers are trained to a high standard and work across new-build handovers, recommissioning and periodic revalidation.
Air balancing ensures that airflow within the cleanroom is correctly distributed and meets the design requirements. Done properly, it delivers uniform airflow patterns and maintains the required cleanliness levels throughout the space.
Cleanroom validation is the process of assessing and documenting a cleanroom’s performance to confirm it meets predetermined standards for cleanliness and environmental conditions.
Key components of cleanroom validation:
Cleanroom commissioning is the systematic process of verifying and documenting that the cleanroom’s design, construction and systems are installed and functioning to specification.
Key components of cleanroom commissioning:
If your cleanroom is due for handover, recommissioning or periodic revalidation, arrange a survey and we will confirm exactly where it stands against its cleanliness class.
Commissioning proves that the cleanroom’s design, construction and systems have been installed and function to specification, and it normally happens once, at handover or after major works. Validation is the ongoing process of measuring and documenting the room’s performance, through particle counting, airflow testing, filter integrity checks and pressure monitoring, to confirm it meets its predetermined cleanliness class. In practice you need both: commissioning gets the facility to its intended standard, and periodic revalidation proves it is still holding that standard once it is in service.
The benchmark in ISO 14644-2 is a maximum of twelve months between classification tests for most cleanrooms, and six months for rooms at ISO Class 5 or cleaner. Many operators in GMP environments test more frequently than the standard demands, and you should also revalidate after any significant change: new equipment, an altered layout, filter replacement or work on the ventilation system. Routine monitoring of particle counts and pressure differentials sits alongside the formal revalidation programme rather than replacing it.
There is no standard price, because the cost depends on the specifics of your facility: the size of the cleanroom and the cleanliness class it has to hold, the number of filters, terminals and test points involved, how accessible the plant and ductwork are, and whether testing has to be scheduled around a live production operation or carried out out of hours. The route we use is straightforward: we carry out a free survey to assess the room against its specification, then give you a fixed written quotation for the full scope before any work is booked.
Integrity testing confirms that each HEPA or ULPA filter, together with its housing and seals, is removing particles at its rated efficiency. A challenge aerosol is introduced upstream of the filter and the downstream face is scanned with a photometer or particle counter; a reading above the permitted penetration reveals a leak in the media, the frame or the seal, which is then repaired or the filter replaced and retested. It sits hand in hand with air balancing, because a filter can only perform when the airflow across it is correct, and the results form part of your validation documentation.
Yes. ISO 14644 defines three occupancy states for testing: as-built, with the room empty; at-rest, with equipment installed but no personnel present; and operational, with the room in normal use. Your specification or GMP requirements determine which state each test must be performed in, and operational testing gives the truest picture of everyday performance. Where production cannot stop, we plan the work around your operation, testing zone by zone or outside production hours, so your cleanliness class is proven without disrupting output.
Yes: the room is only as clean as the air delivered into it. Dust, debris or microbial growth inside the supply and extract ductwork loads the terminal filters faster, disturbs the balanced airflow and can undermine the pressure regime your validation depends on. Keeping the distribution system clean is part of holding your cleanliness class between revalidations, so it pays to put it on the same schedule. Our air ventilation and ductwork cleaning service works to BESA TR19 guidance and pairs naturally with a cleanroom validation programme.
Validation and commissioning are evidential processes, so the documented record matters as much as the testing itself. You receive the measured results for every test performed: particle counts against the ISO 14644 class limits, airflow velocities and volumes, pressure differentials, filter integrity results and, where specified, microbial monitoring and temperature and humidity data. The report states clearly whether the room met its specification in each area and is written to stand up to customer audits and GMP inspection. User training on the correct use and maintenance of the facility can also be included at handover.
We walk the system, tell you what’s compliant and what isn’t, and put it in writing. A named engineer replies within 24 hours.