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.


A 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.

• Air flow Test & ACPH Calculations
• Installed Filter System Leakage Test (using PAO)
• Non-Viable Particle Count Test
• Recovery Test
• Air Flow Pattern Test (Using Water Fogger)
• Air Pressure Balancing
• Containment test
• Temperature & RH Measurement
• Light Intensity Measurement
• Sound Level Measurement

Once 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.


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. 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 TSI Accubalance Air Capture Hoods of Model No.8375, assures accurate test results. The hood measures air volume flowing through registers, diffusers and grills. Weighing just 3.5 kgs, these air capture hoods are easy to use and carry. These hoods simply hold the accubalance up to a diffuser or grill and read direct supply or exhaust airflow on the large digital display.


We 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 guides. This visual monitoring service is important in:


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.


We are Autocal a reputed name in 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.


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 IES-RP-CC-001-86 & ISO 14644. We are equipped to perform HEPA Filter Integrity Test with both Di–Octal Phthalate (DOP) and Poly Alpha Olefin (PAO) depending on client-facility's specific requirements. 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.