Clean Room Validation
AIR VELOCITY TEST
Air velocity test is important to conduct periodic monitoring of filter attributes such as uniformity of velocity across the filter (and relative to adjacent filters). Variations in velocity can cause turbulence that increases the possibility of contamination. Velocities of unidirectional air should be measured 6 inches from the filter face and at a defined distance proximal to the work surface for HEPA filters in the critical area. Velocity monitoring at suitable intervals can provide useful data on the critical area in which aseptic processing is performed. HEPA filters should be replaced when non uniformity of air velocity across an area of the filter is detected or airflow patterns may be adversely affected. 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.
HEPA TERMINAL FILTER EFFICIENCY & INTEGRITY TESTING
HEPA filters are an essential component in any Clean Room design. In fact, their use is dictated by GMP regulations. In a properly designed HVAC system for a Pharmaceutical facility, HEPA filters are essential for maintaining the cleanliness (classification) of an area. Therefore, GMP regulations and ISO 14644 guidelines dictate that HEPA filters shall be periodically tested to verify their efficiency and integrity. HEPA filters will lose their efficiency over time due to clogging, they may be ineffective due to improper installation or they could be damaged (holes, rips) during installation or plant maintenance activities. To verify the integrity of HEPA/ULPA filters and to stay in conformance with various standards and/or governing agency requirements, filters should be tested and evaluated at potentiality twice annually. Proper documentation and certification also helps predict potential performance issues and increases filter life.
NON VIABLE PARTICLE COUNT TEST:
Aerosol Particle Counters are used to determine the air quality by counting and sizing the number of particles in the air. This information is useful in determining the amount of particles inside an Area or in the ambient air. It is also useful in understanding the cleanliness level in a controlled environment. A common controlled environment aerosol particle counters are used is a cleanroom. Cleanrooms are used extensively in semiconductor manufacturing, biotechnology, pharmaceutical, disk drive, aerospace and other fields that are very sensitive to environmental contamination. Cleanrooms have defined particle count limits. Aerosol particle counters are used to test and classify a cleanroom to ensure its performance is up to a specific cleanroom classification standard. We provides complete airborne particle count cleanliness classification test is performed to determine the actual particle count level within the facility at the time of the test (As-Built, At-Rest, or Operational).
AIRFLOW DIRECTION TEST
The purpose of the airflow parallelism test is to show the actual airflow pattern throughout the unidirectional cleanroom. It can also be used to demonstrate the effects on airflow caused by equipment. This test should be performed after all airflow velocity and uniformity tests and room pressurization tests have been performed.