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Validation & Calibration

Validation & Calibration

Ultrafil Air Systems (I) Pvt. Ltd. is professional managed company who are in to manufacturing of air filter for clean room. HVAC and clean room equipments, we have seperate team for validation and calibration of various clean room, equipment, instruments etc.

Ultrafil can provide a comprehensive test and maiantainance solution for virtually any clean air device or clean room facility. We are committed to our clients needs and aim to be the preferred choice for clean room validation. We can submit protocol as per client requirement DQ,IQ,OQ,& PQ.

The validation report describes in detail the test programme and quantifies all results and measurements. Test reports include all the test sheets for laminar flow cabinets,safelty cabinets,isolators clean room, fume cupboards etc. Each sheet has been devised to cover all the requirements of the relevant standard. Airborne particle count sheets include printouts of all the airborne particle counts taken on site.

We can validate to all international standards including ISO14644:1999EEC GMP:2002,FedStd 209EEC GMP:2002,FedStd 209E:1992,BS 5295:1989and IES-RP-cc006.2 etc.

Test certificates certify that the room or device which was tested meets the relevant standard. The plans section will include drawings of all the areas surveyed. Showing airborne particle count positions. Differential pressures and other information appropriate to the validatoin. Calibration certificates are included for instruments used in the test programme.

Air Flow Measurement, Air Velocity/Air Changes

To measure the airflow velocity across the filter, room air volume,
number of air changes, check the differential pressure inside the clean room. 

Instruments used:
1) Anemometers (Fan type / Hot wire).
2) Air capture Hood

Differential Pressure Test

We conduct room pressurization test for cleanrooms.
As a part of the validation process, this test verifies that a pressure differential meet the specified requirements.

Instruments used:-
1) Magnehelic Gauge & Manometer

Hepa Filter Integrity (Leak) Test

This test is carried out to check the Hepa filter media
integrity leak test.

Instruments used:-
1) Photometer (with inbuilt printer).
2) Aerosol generator.

Non-Viable Particle

To Check class of cleanliness as per ISO/EU GMP/
WHO/ Federal STD .This test provide the classification
of the area has been achieved with regard to the concentration of air borne particulate.

Instrument used:-
1) Particle counter (with inbuilt thermal printer).

Recovery Test

Demonstrates the ability of the room to remove the particulate by purging the area with filtered air and then the room can change from a dirty to clean state within specified time.

Instruments used:-
1) Particle counter
2) Aerosol generator

Sound Level Measurements

The noise  level test that Measure the sound pressure.

Instrument used:

  1. Digital Sound meter

Temperature & Humidity Measurement (Mapping)

Data Loggers with wired sensors & Wireless Data Loggers. Small compact battery operated having LCD display, inbuilt memory & data  downloading port with software.
Instruments used:-
1) Data Logger (8/16/24/32 channel) with wired sensors.
2) Wireless data loggers (Battery operated)

Compressed Air (Purity Test)

Parameters to be done:-
Oxygen, Nitrogen Oxide (No2), Carbon Dioxide, Sulphur Dioxide (SO2), Oil mist, Water Vapor, Dew Point, Carbon monoxide .

Instruments used:-

  1. Dew Point Indicator, Digital Stop Watch, Pressure Gauge, RTD sensor, Non-Viable Particle Counter, Gas-tec tubes, Compressed air kit.

Air Flow Pattern Test

Clean rooms as well clean room equipment to determine
the air flow direction is positive laminar as per design.
Instruments Used:
1) Digital video recorder handy cam
2) Water fogger or Dry ice fogger or Glycol fogger

Light Intensity (Or) Lux Level Measurement Test

To verify that the installed light levels. Uniformity meet the specified requirements. We make use of modem testing instruments for assessment of lighting lux levels and intensity.
Instrument Used:-
1) Digital LUX meter

Containment Leak Test:-

To determine if there is intrusion of contaminated air into the clean zones from surrounding non-controlled area at the same or different static pressure level.
Instruments used:-
1) Aerosol photometer
2) Aerosol generator

NABL & Non-NABL(Calibration) Services

Calibration of Thermal Parameters Range (-80 to 1150 PC/20 to 90% RH):-

Instruments Used:
Temp, bath, Data logger with sensor, RTD sensor,
thermocouple, 6% I /IM/ digital thermometer,
Humidity chamber, RH & temp indicator with Sensor.

Calibration of pressure gauges, vacuum gauges, Compound gauges, transmitters, transducers, switches:-

nstruments used:-
Digital pressure gauge, Comparison test pump, Vacuum
test pump, Differential pressure gauge, Digital manometer.

Air Velocity

Calibration of instrument (Anemometer, Air capture hood)
Instrument used:-
Air velocity test pump.

Annual Maintenance Contract (AMC):-

We undertake AMC Contracts to maintain clean rooms / HVAC systems / clean room equipments.
The following checks are conducted periodically in our AMC

  • To check the AHU conditions (filters cleaning replacement), Blower plus Motor assembly, AHU doors accessories.
  • Check the condensing units / chilled water systems, valves, controllers.
  • Check the electrical control panel operations.
  • Calibration of Magnehelic / pressure /temp, gauges, indicators, sensors etc., validation of cleanroom.
  • Check the cleanroom doors / panels / accessories interlocking
  • Ducting with insulation, dampers, accessories check, maintain, replacement, documentation at your site
  • Cleanroom equipment repairs / modifications. Documentation work based on site conditions DQ, IQ, OQ, PQ