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WHY VALIDATE?

Air quality in clean rooms and clean air devices is critical in many areas of work including the process and manufacture of pharmaceutical products, operating theatres and sterile services departments. When a clean room has just been built it must be tested to ensure that it is working correctly.

The quantity and quality of air supplied, the air movement between and within clean rooms and the particle (and where necessary microbiological) counts in the clean room should be shown to be correct. These requirements are laid down in ISO 14644-1.