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Clean Room Validation

CleanRoom Validation/ HVAC Validation

We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals.

CADILLAC undertakes Clean Room Validations for different sectors as follows:

  • Pharmaceutical Sectors
  • Hospital Sectors
  • Scientific Research & Development sectors
  • Diagnostic & Pathology Lab
  • Food & Beverages Sectors
  • FMCG Sectors
  • Objects of the validation includes
  • Pharmaceutical Processing Zones
  • Operation Theatres (OT)
  • Critical Care Units (CCU)
  • Microbiology/QC Laboratories
  • Laminar Air Flow Benches (LAF)
  • Bio-safety Cabinets
  • Sampling Booths
  • Dispensing Booths
  • Fume Hood etc.
  • Standards /Guidelines we follow
  • ISO 14644
  • US FEDERAL 209E
  • GMP SCHEDULE M
  • NABH
  • CDC
  • ISO 8995
  • ISO 3741
  • ISO 10816
  • CADILLAC carries out following tests to validate clean rooms/clean zones.

    Particle Count Test

    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 , c 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.

    DOP Test/PAO Test/HEPA Filter Integrity Test

    We conduct complete HEPA/ULPA filter integrity testing services. All filter integrity tests performed by us are executed in accordance with 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.

    Air Velocity Test/ ACPH measurement

    We conduct Air Velocity 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.

    Airflow Visualization Test

    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. This visual monitoring service is important in:

    Clean Room laminar flow tests

  • Airflow balancing
  • Fuming Hoods
  • Leak detection in ducts
  • Point Exhaust tests
  • Personnel safety exhausts verification
  • Pressure balancing between rooms and spaces
  • Temperature and Humidity Test

    Two levels of Temperature and Relative 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.

    Room Pressurization Test

    Pressurization Test verifies the specified relative differential pressure (positive/negative) among the clean zones. This test is very necessary to prevent contamination hazards.

    Recovery Test

    Recovery tests demonstrate the ability of the clean room/AHU system 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.

    Swept Test

    The purpose of swept test is to assess how much time a room takes to change its cleanliness class after stopping the Air Handling Unit system. It helps to determine the efficiency of the AHU system.

    Light Intensity Test

    The purpose of this test is to verify that the installed light levels and uniformity meet the specified requirements. We make use of modern testing instruments for assessment of lighting lux levels and intensity.

    Noise Level Test

    we perform noise level test that measures the sound level of both environment and equipment.

    Vibration Level Test

    Vibration level test measures the vibration of various equipment like Air Handling unit,Biosafety Cabinet, Laminar air flow bench and any other machine tools.

    DQ/IQ/PQ/OQ Documentation

    We also offer documentary works for DQ/IQ/PQ/OQ for both new & old projects

    Equipment List for Clean Room Validation
    Sl. No. Testing Parameter Equipment Used
    1 DOP/PAO HEPA Filter Integrity Test
  • DOP Generator
  • DOP Photometer
  • 2 Particle Count Test Laser Particle Counter
    3 Room Pressurization Test Differential Pressure Gauge
    4 Airflow Visualization Test
  • DI Water Fogger
  • Digital Camera
  • 5 Recovery Test
  • DOP Generator
  • Laser Particle Counter
  • 6 SweptTest
  • DOP Generator
  • Laser Particle Counter
  • 7 Temperature and Humidity Test
  • Digital IR Thermometer
  • Digital Thermo-Hygrometer
  • 8 Air VelocityTest/Air Change per Hour Calculation(ACPH)
  • Digital Vane Type Anemometer
  • Digital Hot Wire
  • Anemometer
  • 9 Noise Level Test Noise Meter
    10 Light Intensity Test LUX Meter
    11 Vibration Level Test Digital Vibration Meter
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