CLEANROOM VALIDATION

What is Cleanroom Validation?

A cleanroom is a controlled environment where contamination is filtered out to ensure that intended production or measurements are not influenced by the presence of any contamination like airbourne particles. Depending on the level of control and filtration, Cleanrooms can have a designated class. These classes are defined by standards like ISO14644-1 and other variations from GMP and FED209E (FED209E standard was cancelled in 2001 and superceded by ISO14644).

Each cleanroom class is a system comprising the design elements of the cleanroom in order to at least meet the requirements for the class and a set of processes / procedures to ensure that contaminants are minimised.

Validation tests are used to evaluate whether the advertised cleanroom class is being met.

Why is Cleanroom Validation Needed?

Validations tests are carried out to confirm that:

• The cleanrooms meets the requirements of the targeted cleanroom class and
• The procedures are adequate and are being followed.

This is important because any airbourne contamination may be detrimental to product manufactured in the cleanroom or if the cleanroom is used for product testing, then any contamination may lead to false results.

What tests are typically carried out?

The tests that are performed on a cleanroom usualy include:

• air exchange rate verification,
• pressure cascade verification,
• airborne particle testing (e.g. Airborne Particle Counters),
• airflow pattern analysis (airflow visualization),
• room differential pressures.

In the case of filtration

• GMP the HEPA filers are DOP tested.

Other tests may include:

• temperature tests (LUX levels),
• humidity tests,
• lighting levels,
• recovery test,
• containment leak test.

A cleanroom that meets the requirements of the target class will be certified. However, a program of regular compliance testing is also required by ISO 14644-2 (Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration). Compliance tests should be carried out every 12 months.

Who can validate a Cleanroom?

Validation is a skilled job and must be carried out by a skilled independent professional.