Cleanrooms require routine testing, monitoring and certification to ensure that these controlled environments continue to perform in accordance with regulatory standards as detailed in ISO14644, EU GMP & EIST.

Lydair specialise in the testing, validation and certification of cleanrooms to procedures set out in ISO14644-3(2019).

Testing is conducted in accordance with ISO14644-1

Cleanrooms and associated controlled environments.

Part 1: Classification of air cleanliness by particle concentration

EU GMP Annex 1, and IEST.

Results being presented in a test report to ISO14644-1(2015)

Test procedures as ISO14644-3(2019) NA.1

Non-Viable Airborne Particle Counting

Establish the classification of the cleanroom environment by particle concentration as ISO14644-1(2015).

At design stage, an estimated “in operation” particle generation and median ventilation coefficient are used to calculate the required volume flow rate as ISO14644-4:2024.

Cleanroom facilities utilise room pressure differentials as part of the air contamination control strategy.

A smoke visualisation test is another recommended method used to demonstrate effective air contamination control.

The leak test establishes the level of leakage, relevant to the cleanliness performance of the installation.

Lydair offer two methods:
Aerosol photometer & Light-scattering airborne-particle counter (LSAPC)
Upstream aerosol challenge Ondina oil or monodisperse PSL.