Cleanroom Validation

EPSCO India is recognized leader when it comes to cleanroom Validation, Calibration and its Certification carried out by high proficient technical staff.

Testing is carried out in accordance with relevant standards (ISO14644-2, 3, 4, EU GMP/EC GMP, FS 209E, WHO 2002, USFDA, MHRA, Drug and Cosmetic Act of India, 2005.

We conduct Cost effective, Timely execution of work, Hassle free management to handle bulk order.
Annual maintenance also provided.

Cleanroom Validation

Cleanroom Validation

We carried following services in validation,

  1. Air Velocity (Flow) Test , ACPH maintaining
  2. HEPA filter integrity Test
  3. Particle count Test
  4. Recovery Test
  5. Pressure balancing Test
  6. Air flow Pattern Test

Air Velocity Testing

Air Velocity Measurement is carried out to determine the filter face velocity, uniformity and the total room airflow volume within a Cleanroom. This test has been performed in accordance to different international guidelines i.e. ISO14644-2, 3, 4, EU GMP/EC GMP, FS 209E, WHO 2002, USFDA, MHRA, Drug and Cosmetic Act of India,

Operation Theatre (OT) Validation

We carried following services in OT validation,

  1. Air Velocity (Flow) Test , ACPH maintaining
  2. HEPA filter integrity Test
  3. Particle count test
  4. Recovery test
  5. Air flow Pattern Test

HEPA filter Integrity Test

HEPA filter integrity test is known as PAO Test. Actually PAO is well known aerosol reagent used in HEPA Filter Integrity Test or HEPA Filter Leakage Test as a challenge aerosol. This test has been conducted by using well known testing instruments i.e. Calibrated TEC Aerosol Photometer & Aerosol Generator.

Particle Count Testing

This is one of the most important Test as per Cleanroom validation concern using TSI Particle Counter (100LPM or 50 LPM) .This test is required to qualify the status of Cleanliness class of Cleanroom, Laminar Airflow Unit, Bio-safety cabinet, Isolators, FBD, FBE, Autoclave, Dry heat sterilizers, Air Showers, Coaters, Garment Cubicles, Vial Sterilization Tunnels, etc.

Pressure balancing Test

The purpose of the air pressure difference test is to verify the capability of the Cleanroom system to maintain the specified pressure differential between the installation and its surroundings. The air pressure difference test should be performed after the installation has met the acceptance criteria for airflow velocity or volume, airflow uniformity and other applicable tests.

Air flow Pattern Test

Air Flow Pattern Test/ Air Flow Visualization Test is required as per ISO 14644. We carry out this test by using distilled water/ WFI based Cleanroom fogger. Due to this no residues will be spread while testing in a Cleanroom. As WFI is sterile one, there is no problem to use in Cleanroom. Also with the help of this we reduce the risk of any chemical used in Cleanroom.