Clean room Validation/HVAC Validation
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- Clean room Validation/HVAC Validation
Clean room Validation/HVAC Validation is performed for a various reasons, to ensure that the design of the facility is fit for its intended purpose and to ensure that the facility, equipment, and environment meets defined regulatory requirements and standards. Bfresh provide an extensive range of services pertaining to clean room validation by our panel of expert professionals available with us.
Bfresh performs the HVAC validations as per ISO 14644-1, 2, 3 EU-GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.
Methods for evaluation and measurements for Certification are specified in ISO14644-3.
Once certified to a particular class the clean room factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control.
Bfresh Validation Services carries out following tests to validate clean rooms/clean zones:
Bfresh 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. The average airflow velocity is calculated by dividing the total of the airflow grid velocities by the number of readings taken.Air Exchange Rate tests determine the total air volume get in to the room within a clean room. The use of Hot wire Anemometer assures accurate test results. The Anemometer measures air volume flowing through diffusers and grills. The use of the hot-wire anemometer permits instantaneous flow velocity to be calculated from electric voltage measurements. The advantage of hot-wire anemometry is associated with its very high spatial resolution and excellent frequency response characteristics. In most cases, the probe-stem is perpendicularly aligned with the mainstream direction of flow.
Bfresh 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 IES-RP-CC-001-86 & ISO 14644. Bfresh are equipped to perform HEPA Filter Integrity Test with Poly Alpha Olefin (PAO). 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.
Bfresh is offering clean room validation services. Our 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, 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.
Bfresh execute recovery tests for clients across Industries and Hospitals. 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. Our technicians have enriching experience and provide clients with high quality service. The ultimate goal of our company is to assure complete satisfaction of clients through effective execution of services and by providing best array of clean room equipment. Bfresh ensure that client's clean room facility is performing properly and accurately.
Bfresh offer Airflow Visualization Test as a part of the validation process. Visualization is carried out by using water fogger 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 guidelines.
Bfresh conduct validation tests that include Temperature and Humidity Measurements / Tests. Two levels of temperature and humidity tests are used by us depending on the requirement. In the first level, general temperature and humidity uniformity are tested. The general level test is used to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for occupant comfort. The second level or the comprehensive level test identified that the clean room HVAC systems needs to maintain the specified levels of temperature and humidity required for both occupant comfort and process temperature control.
The purpose of the lighting level tests is to verify that the installed light levels and uniformity meet the specified requirements. Bfresh make use of modern testing instruments for assessment of lighting Lux levels and intensity.
Bfresh 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.
