HEPA TERMINAL FILTER EFFICIENCY & INTEGRITY TESTING In the design of any Clean Room, HEPA filters are a vital component. GMP regulations dictate their use. In a Pharmaceutical facility, a well-designed HVAC system requires the use of HEPA filters to ensure the cleanliness and classification of specific areas. GMP regulations and ISO 14644 guidelines mandate [¡K]
NON VIABLE PARTICLE COUNT TEST Aerosol particle counters play a crucial role in assessing air quality by quantifying and sizing particles present in the air. This information is valuable for determining particle concentration in a specific area or the surrounding ambient air. It is particularly useful in evaluating the level of cleanliness within controlled environments [¡K]
STANDARD AND REGULATION The preparation of the Documents and the Execution of the OQ testing are in accordance with the following guidelines, as aminimum: EU-GMP USFDA ISO 14644
AIR VELOCITY TEST Conducting periodic air velocity tests is essential for monitoring filter attributes, particularly the uniformity of velocity across the filter and in comparison to adjacent filters. Variations in velocity can lead to turbulence, increasing the risk of contamination. For HEPA filters in critical areas, we recommend measuring velocities of unidirectional air at a [¡K]
AIR FLOW DIRECTION TEST The airflow parallelism test serves the purpose of illustrating the true airflow pattern within the unidirectional cleanroom, as well as highlighting any airflow disruptions caused by equipment. It is essential to conduct this test after completing all airflow velocity, uniformity, and room pressurization tests.
