Buyer guide
Cleanroom validation and handover: tests, IQ/OQ/PQ and documents
Validation proves that a finished cleanroom meets the owner's written requirements, using ISO 14644 tests and, at pharmaceutical sites, the IQ, OQ and PQ stages of EU GMP Annex 15. The contractor supplies test data and records, the owner approves them, and the regulator, not the contractor, judges the facility.
By ZY Cleanroom · Updated · Sources at the end of the page
Tests under ISO 14644
Particle counting for classification is set out in ISO 14644-1, not in Part 3. ISO 14644-3:2019 covers the supporting tests, in three occupancy states: as-built, at-rest and operational. Its Annex A helps a project choose which tests apply.
| Supporting test | What it shows |
|---|---|
| Air pressure difference | Pressure steps between rooms hold as designed. |
| Airflow, volume and velocity | Supply air meets the design figure. |
| Airflow direction and visualisation | Air moves from cleaner to less clean areas. |
| Recovery | How fast the room returns to its class after a particle load. |
| Installed filter system leakage | Filters and their seals do not leak. |
| Temperature and humidity | Room conditions hold as specified. |
More tests, and the GMP list
ISO 14644-3 also lists containment leak, electrostatic and ion generator, particle deposition and segregation tests, for rooms where they apply. EU GMP Annex 1 (2022), paragraph 4.25, lists nine qualification tests for sterile manufacturing, where relevant. It adds airborne and surface microbial contamination, which ISO 14644-3 does not list.
IQ, OQ and PQ
EU GMP Annex 15 (2015) describes these stages for the facilities, equipment, utilities and systems of medicinal product manufacturers. Annex 1 says cleanroom qualification should follow Annex 15.
| Stage | What it covers |
|---|---|
| URS | The owner's written requirements, a reference point for the whole project. |
| DQ | Evidence that the design meets the URS. |
| FAT and SAT | Checks at the vendor and on site, where used. |
| IQ | Installation checked against drawings and specifications, instruments calibrated, materials verified. |
| OQ | Tests that the system operates as designed, including upper and lower limits. |
| PQ | Tests that it performs under normal operating conditions, normally after IQ and OQ. |
Documents at handover
Annex 15 applies to pharmaceutical manufacturing. Other industries can borrow the stages if the customer specification asks for them.
No standard gives one fixed handover list, so agree the list in the contract. These records follow from the standards above.
| Document | Basis |
|---|---|
| Drawings that match the installation | Annex 15, IQ (3.9) |
| Operating and maintenance instructions | Annex 15, IQ (3.9) |
| Instrument calibration records | Annex 15, IQ (3.9) |
| Materials of construction records | Annex 15, IQ (3.9) |
| Test reports for each test | ISO 14644-3:2019, clause 5 |
| Classification results by occupancy state | ISO 14644-1:2015 |
| Airflow visualisation recordings | Annex 1, 4.15 (video recordings retained) |
| FAT and SAT records, deviation reports | Annex 15, 2.8 and 3.4 to 3.7 |
Who is responsible for what
Annex 15 allows data from outside the manufacturer's own programme, such as contractor tests, if the use is justified and controls were adequate when the data were taken.
| Party | Responsibility |
|---|---|
| Owner (manufacturer) | Defines the URS, approves protocols and reports, confirms that vendor protocols suit the site, and keeps the validation programme (Annex 15, 1.4, 2.2, 2.6, 3.2). |
| Contractor | Delivers the scope in the contract: design, build, tests and records. ISO 14644-4:2022 does not prescribe the contractual split. |
| Regulator | Inspects the manufacturer. In the EU, the national authority issues a GMP certificate to the manufacturer after inspection (EudraGMDP). FDA does not issue CGMP certificates at the end of an inspection (FDA Data Dashboard). |
Next step
To have a room list reviewed, send it to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel and door factory in Tianjin, China.
ISO 14644 certification testing: the steps of a classification run
A classification run, often called certification, follows one order. ISO 14644-1 sets the class limits. EU GMP Annex 1 (25 August 2022) paras 4.26 to 4.29 add that classification is part of qualification, counts particles of 0.5 and 5 µm, and is done at rest and in operation. The owner's quality system, not the test provider, accepts the result.
Worked example: at ISO 7 and 0.5 µm the sample volume is 20 ÷ 352,000 × 1,000 = 0.057 L, so the 2 L minimum governs. A counter drawing 28.3 L/min (1 cubic foot per minute) collects 28.3 L in the 1-minute minimum. At ISO 5 the formula gives 20 ÷ 3,520 × 1,000 = 5.68 L, which the same counter also collects in 1 minute.
| Step | What happens | Basis (checked 1 November 2026) |
|---|---|---|
| 1 | Agree the class, the occupancy state and the particle sizes in writing. | ISO 14644-1:2015; Annex 1 paras 4.27 and 4.29 |
| 2 | Check the particle counter's calibration record. | ISO 21501-4:2018 sets the calibration and verification method for light scattering airborne particle counters used for classification |
| 3 | Set the sampling locations from the floor area. | ISO 14644-1 Annex A sets a minimum by area, for example 1 location up to 2 m² and 5 up to 10 m², as reproduced by Pharmaguddu (updated 3 July 2025). Annex 1 para 4.28 adds locations for grade A and B and critical points such as the point of fill. |
| 4 | Work out the sample volume at each location. | Vs = 20 ÷ Cn,m × 1,000 litres, at least 2 L and at least 1 minute per location, as quoted by Beckman Coulter from ISO 14644-1 |
| 5 | Count in the agreed state, scheduled so process and product are not affected. | Annex 1 para 4.26; at-rest limits met after a clean-up period, guidance under 20 minutes (para 4.29) |
| 6 | Compare each result with the Table 1 limit and write the report with the class, the state and the particle sizes. | ISO 14644-1:2015, Table 1; Clean Room Technology, tips for ISO 14644-1:2015 |
| 7 | Repeat when due, and after remedial action or changes. | Annex 1 para 4.32: at most 6 months for grade A and B, 12 months for grade C and D |
Questions
Common questions
Is particle counting part of ISO 14644-3?
No. Classification by particle count is in ISO 14644-1. Part 3 covers supporting tests such as pressure, airflow, recovery and filter leakage.
Who signs off validation?
The owner. Annex 15 says validation documents are approved by personnel defined in the owner's pharmaceutical quality system.
Can a contractor's test data be used for validation?
Yes, if the owner justifies it and controls were adequate when the data were taken (Annex 15, Principle).
Does the contractor get the room approved by the regulator?
No. Regulators inspect the owner's facility and quality system. A contractor supplies the room, the tests and the records.
What is factory acceptance testing for a cleanroom?
Factory acceptance testing checks equipment or assemblies at the vendor's works against an agreed test list before shipping. Faults found there are easier to fix than faults found on site. EU GMP Annex 15 allows some factory tests to count only if transport and installation do not affect the function. Airflow, pressure and particle class still have to be proven in the finished room.
How often should a cleanroom be recertified?
For GMP rooms, Annex 1 sets maximum requalification intervals of 6 months for Grades A and B and 12 months for Grades C and D. Published summaries of ISO 14644-2:2015 give maximum particle count intervals of 6 months for ISO 5 and cleaner, and 12 months for ISO 6 and above. These are upper limits, so set the real frequency in a risk-based monitoring plan.
Related guides
- Upgrading an existing cleanroom for EU GMP Annex 1: gap list
- Pass box qualification: DQ, IQ, OQ and PQ
- Contamination control strategy: what the building and air must provide
- USP <797> compounding cleanroom for hospital pharmacy
- Turnkey cleanroom contractor
- Room list builder
Sources
- ISO 14644-3:2019, Cleanrooms and associated controlled environments, Part 3: Test methods (published August 2019; contents list checked 31 October 2026)
- ISO 14644-1:2015, Cleanrooms and associated controlled environments, Part 1: Classification of air cleanliness by particle concentration (published 9 December 2015; Table 1 checked 31 October 2026)
- ISO 14644-4:2022, Cleanrooms and associated controlled environments, Part 4: Design, construction and start-up (approved 28 November 2022; scope checked 31 October 2026)
- EudraLex Volume 4, Annex 15: Qualification and Validation (European Commission, 30 March 2015; in operation from 1 October 2015; checked 31 October 2026)
- EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products (published 25 August 2022, applied from 25 August 2023; checked 31 October 2026)
- EMA, EudraGMDP public database: GMP certificates are issued by the national competent authority that carried out the inspection (checked 31 October 2026)
- FDA Data Dashboard, Inspections: FDA does not issue CGMP certificates at the conclusion of an inspection (checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
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