The test is carried out in accordance with ISO 14464 and EU GMP ANNEX 1, in accordance with the required level of cleanliness and proper functioning of the room according to the standard.
The tests performed are mandatory tests and optional tests:
⦁ Particle inspection – level of cleanliness in a number of points in the room, according to the standard guidelines
⦁ Test the flow velocity of HEPA filters
⦁ Test pressure differentials between rooms
⦁ Test the flow of smoke through a smoke generator, recorded on a hard disk
⦁ Calculate air flow and number of air changes
⦁ Test temperature and humidity
⦁ Test the light intensity measured in LUX
⦁ Noise testing
⦁ Integrity test HEPA filters
⦁ Recovery room test
When the tests are complete the tests results will be recorded in the test report including a serviceability tag in the room.