Why is the validation of the cleanroom or flow cabinet so important? That is a question often asked to our validation engineers. According to ISO14644-1:2015, cleanrooms and flow cabinets have to be validated in accordance with a maintenance and validation programme tailored to the individual process. Depending on the ISO class, cleanrooms with ISO class 6 or higher are usually validated with an interval of 12 months, for cleanrooms or flow cabinets with ISO class 5 or lower, the validation interval is usually 6 months.
How are cleanrooms validated?
Validation is done according to a standard predetermined international (ISO14644-1:2015) validation protocol, it serves to ensure that the cleanroom is properly designed, installed and functions for its intended ISO classification..
Standard validation by ProCleanroom:
- Particle counts (concentration of airborne particles)
- Measurement of air velocity
Additional tests:
- Measurement of light intensity (lux)
- Air Changes (circulation rate)
- Pressure difference test
- Aerosol smoke visualisation test
- Measurement of noise – sound pressure level (dB (A))
- Temperature and humidity measurements
- HEPA or ULPA filter integrity test/efficiency test (Aerosol challenge/DOP test)
Validation can be performed in three different ways:
“As built” validation:
The validation is performed in a working cleanroom or flow cabinet, but no materials, production equipment, or employees are present. This type of validation proves that the cleanroom or flow cabinet is correctly installed and achieves the desired ISO class.
“At rest” validation:
This validation is performed in a fully equipped cleanroom or flow cabinet when its not in operation, no employees are present during this type of validation. This type of validation proves that the installed (stainlessteel) furniture and equipment do not emit additional contamination in the controlled environment.
“In operation” validation:
This validation is performed in a fully operational cleanroom or flow cabinet with all the employees and equipment present. This type of validation proves that the desired ISO class is achieved.
After a validation has been performed you will receive a provisional quality paper. The comprehensive, definitive validation report will be in your possession within 1-2 weeks. We also provides periodic validations for our customers. This way, quality is ensured. Besides our own cleanrooms, we also validates fixed cleanrooms by other suppliers.
Interested what ProCleanroom can do for you? Then make an appointment with one of our qualified CTCB-I engineers.
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