HVAC VALIDATION:
Cleanroom Validation/HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us. Autocal 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.Cleanroom Certification validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:Monitor And ControlA constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2. Statistical analysis for cleanroom parameters is encouraged as a tool for monitoring the cleanroom after certification to ensure compliance. The tool of choice is statistical process control, SPC.Methods for evaluation and measurements for Certification are specified in ISO14644-3. It calls out for the following ten tests. 1.Air flow Test & ACPH Calculations 2.Installed Filter System Leakage Test (using PAO) 3.Non-Viable Particle Count Test 4.Recovery Test 5.Air Flow Pattern Test (Using Water Fogger) 6.Air Pressure Balancing 7.Containment test 8.Temperature & RH Measurement 9.Light Intensity Measurement 10.Sound Level MeasurementOnce certified to a particular class the cleanroom factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control.Autocal carries out following tests to validate clean rooms/clean zones.