Testing & Validation

With a personalized cleanroom qualification testing schedule, AXENIC SYSTEM Cleanrooms will verify the class or grade of your cleanroom facilities and localised clean air devices, then produce an instant interim report followed voluntarily by a full report as evidence for auditors. We conduct a series of tests to provide cleanroom validation to qualify if a controlled environment is performing in accordance with procedure requirements and the appropriate regulatory guidelines, such as ISO 14644-1:2015 or GMP Annex 1.

For every cleanroom, testing and validation is an important procedure. A cleanroom testing and validation service is a procedure that certifies that the cleanroom is properly installed and designed for its intended classification and that the regulations and other distinct standards for all components are met. The cleanroom testing and validation comprises several phases from the design to the concluding certification. Airflow and velocity tests, a HEPA/ULPA filter integrity leak test, air movement visualisation, airborne particle count tests, room pressure tests, relative humidity and temperature testing are some of the tests conducted in these stages.

The cleanroom is then certified to a certain class that specifies its level of control, for example, to meet the standards of the ISO 14644 class.

Once you have completed the preliminary certification, it’s significant to recertify regularly in order to keep your cleanroom functioning as it was when it was constructed. It is suggested to obtain annual certification at a minimum. Twice or four times in a year certification may be necessary, depending on your industry, products or level of certification required.

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