Cleanroom Validation & Certification

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).

Validation Services:

Airborne Particle Count
Measurement of airflow volume flow rates
Measurement of static pressure differentials
Recovery times & recovery rates
Airflow pattern visualisation
HEPA filter integrity testing

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).

Supply Air Flow Rates

Cleanroom Validation requires the measurement of supply air flow rates and airflow velocities, in accordance with ISO14644-3 :2019. B2.2 & B2.3

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.

Room Pressures

ISO 14644-3:2019. B1.2

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

Recovery time / Recovery Rates

A measured local recovery time/rate is a recommended method used to demonstrate effective air contamination control.

Evaluation by 10:1 or 100:1 recovery time

ISO 14644-3:2019. B4.3

Airflow Visualisation Testing

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

HEPA Filter Integrity Testing

In situ HEPA Filter Integrity Testing.

Method as detailed in ISO14644-3:2019 adapted from IEST-RP-CC034.4

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.

Testimonials

Working with Lydair during the build and commissioning of our new 4,000²m cleanroom manufacturing facility was a pleasure and an education to say the least.

Lydair’s obvious enthusiasm not only for the cleanroom controls but also for helping people improve their subject knowledge is clear to see. His relaxed and disarming personality was invaluable during some challenging times during the commissioning stage. Working with the main contractors and cleanroom installation contractors in achieving our cleanroom requirements, Neil overcame initial “obstructive” reactions which resulted in a very good working relationship and final achievement of our goals.

Lydair had, and still has, valuable input into the ongoing running of the cleanroom facility. His ongoing guidance has increased our knowledge of cleanroom manufacturing requirements and in some cases has actually lowered our equipment requirements due to the knowledge that Neil has imparted.

Lydair continues to support this business on developing our knowledge and is actively involved in new manufacturing projects destined for the cleanrooms.

Bio Pure Technology Ltd

Working with Lydair on our routine maintenance and validation schedule is always a pleasant experience.
Neil and his colleague(s) are accommodating and professional when working alongside our in-house maintenance team and the principle contractor who carries out the servicing and filter changes.
Neil takes a pragmatic approach to supporting our Controlled-Clean Packaging Cubicles and has been invaluable in providing support to us and other contractors with advice and guidance on new projects both large and small.
The knowledge and experience Lydair can provide regarding clean room standards and problem solving has been invaluable. We have some significant upgrades and new builds scheduled over the next few years that Lydair will be working on with us and the principle designers to ensure that the design, build, commissioning and validation goes as smoothly as possible.