At Techno Air Gate we performs the HVAC validations as per ISO 14644, EU cGMP, US Federal Standard 209E, WHO guidelines for all room classifications. We can provide operational resources and assistance with the generation of User Requirement Specifications (URS), Factory acceptance test (FAT), site acceptance test (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
what we can carry out
HVAC Qualification Tests
Air Exchange Rate
Air Exchange Rate tests determine the total air volume get in to the room within a clean room. The use of Air Capture Hoods, assures accurate test results. The hood measures air volume flowing through registers, diffusers and grills.
Room Pressurization test
We conduct Room Pressurization Test for industrial clean rooms. As a part of the validation process, this test verifies that a pressure differential meet the specified requirements.
Air Velocity Measurement
We conduct Air Velocity Measurement / tests to determine the average filter face velocity and uniformity, and the average room airflow velocity and uniformity within a clean room.
HEPA filter integrity test
We conduct complete HEPA/ULPA filter integrity testing services. These are offered for both the Pharmaceutical and Microelectronics industries. All filter integrity tests performed by us are executed in accordance with ISO 14644. The tests assure that client’s filters are in conformance with various standards and/or governing agency requirements. Testing and evaluating filters minimum once annually and potentiality twice annually is required for optimum performance. Proper documentation and certification is provided by us and this also helps predict potential performance issues and increases filter life.
Airflow Visualization Test
We offer Airflow Visualization Test as a part of the validation process. Visualization is carried out by using smoke generator and taking Video Graph. The purpose of the airflow visualization test is to show the actual airflow pattern throughout the unidirectional clean room. The test can also be used to demonstrate the effects on airflow caused by equipment. It is best to perform this test after all airflow velocity and uniformity tests and room pressurization tests have been performed. The test determining the airflow patterns within a room using ISO 14644 guides.
Particle Count Test
Particle Count Test provides complete airborne particle count cleanliness classification. The test is performed to determine the actual particle count level within the facility at the time of the test. The test identifies particle count on basis of As-Built, At-Rest, or Operational as per ISO 14644-(2015), EU GMP. The particle size(s) of interest, the room occupancy state and the room classification shall be known prior to the beginning of the tests and shall be as specified in the URS documents.
We execute recovery tests for clients across Industries. These tests demonstrate the ability of the clean room to remove particulate by purging the area with filtered air. It also testifies if the room can change from a “dirty” to “clean” state within the specified time. The test is conducted by experienced technicians from team.
Temperature and Humidity Measurements
We conduct validation tests that include Temperature and Humidity Measurements / Tests. The test is used to ensure that the clean room’s HVAC system maintains the specified levels of temperature and humidity required for both occupant comfort and process temperature control.
We conduct Containment Tests for client’s clean room facility. The test is carried to demonstrate that airborne contamination does not enter from a higher pressure area adjacent to the clean room by means of leaks in the construction materials. The test is conducted by trained and experienced technicians using modern instruments that assure accurate results.
Noise level test
We perform noise level test that measure the sound pressure. The measurements will vary based on the occupancy state-of-the-art clean room. The purpose may vary but the procedures of testing are identical.
Light intensity test
The purpose of the lighting level tests is to verify that the installed light levels and uniformity meet the specified requirements. We make use of modern testing instruments for assessment of lighting lux levels and intensity.