Cleanroom testing and certification to ISO 14644

Cleanroom testing means measuring airflow, checking HEPA filters for leaks, checking pressure differentials between rooms and counting airborne particles as ISO 14644-1 requires, to confirm the room meets its design specification.

Key facts

Main standards

ISO 14644-1:2015 (classification), ISO 14644-2:2015 (monitoring), ISO 14644-3 (test methods), PIC/S GMP Annex 1 (PE 009-17)

Occupancy states we test

As-built, at-rest, operational

Who needs it

Pharmaceutical plants, medical devices, hospitals, food, electronics

Deliverables

Results for each test, a sampling location plan, acceptance criteria, pass/fail conclusions and copies of instrument calibration certificates

Tests

Group	Test	Purpose
Core (classification)	Airborne particle count	Determines the room ISO Class to ISO 14644-1
Core	Airflow velocity / volume	Confirms clean air supply and air change rate
Core	Room pressurisation	Controls the direction of flow from cleaner to less clean areas
Core	Installed filter leak test (HEPA)	Confirms the filters and frames do not leak
Additional	Airflow visualisation (smoke pattern)	Shows the direction of airflow, confirming there is no backflow from lower-grade to higher-grade areas and that air does not move from less clean zones, or across operators or equipment, in a way that could carry contamination into higher-grade areas
Additional	Recovery test	Measures how long the room takes to return to its clean state after a contamination event
Additional	Temperature, humidity, lighting, noise	Checks the environment against the design
Equipment	Biological safety cabinets (BSC), laminar airflow units (LAF), AHUs	Confirms the equipment operates within specified values

Photos from real sites

Examples of tests carried out by the QV TEST team in clients’ cleanrooms

Measuring airflow at a HEPA diffuser with a capture hood

Scanning an installed HEPA filter for leaks

Counting airborne particles with a particle counter to classify the ISO Class

Reading the pressure differential between rooms

Airflow visualisation with smoke (smoke pattern test)

Measuring air velocity below a HEPA filter

How we work

We collect room data: area, the ISO Class or GMP Grade required and the occupancy state to be tested, and review the room layout

We calculate the number of particle sampling locations from ISO 14644-1 Table A.1 and prepare the sampling plan

We test on site with calibrated instruments

We analyse the results against the criteria and prepare the report

Frequently asked questions

How often must a cleanroom be retested?

ISO 14644-2:2015 sets a maximum interval of 12 months for particle counting, airflow volume or velocity, and pressure differential. PIC/S GMP Annex 1 (PE 009-17) requires requalification of Grade A and B areas every 6 months and Grade C and D areas every 12 months.

How do ISO Class and GMP Grade differ?

ISO Class (1–9) is the cleanliness level based on particle concentration in ISO 14644-1. GMP Grade (A–D) is the level used for sterile medicinal product manufacture under PIC/S GMP Annex 1, which sets both particle and microbial limits in the at-rest and operational states.

How many particle sampling locations are needed?

It depends on the room area, per ISO 14644-1:2015 Table A.1. For example, a 10 m² room needs 5 locations, a 52 m² room 10 locations and a 1,000 m² room 27 locations.

What do I receive after testing?

A report covering every test with the sampling location plan, acceptance criteria, conclusions and copies of instrument calibration certificates.

Request a quote

Tell us the number of rooms, their area and the ISO Class or GMP Grade you need, and we will propose a scope and price