|Cleanroom Type||Modular Cleanroom|
|Room Size||<200 Square Feet|
|Service Location||Client Site|
Pharmintech offers a gamut of Clean Room Testing And Validation for Equipments & Clean room facilities based on the thorough understanding of cGMP standards.
We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us.
We perform validations as per ISO 14644, EU cGMP, US Federal Standard 209E, USFDA, guidelines for all room classifications.
All testing, reports and certification is regulated by our operating process which constitute part of our Quality Manual.
Any parameter outside the allowable range will be reported immediately and strategies and measures will be put in position to correct abnormal activity.
Our Validation Services include,
- Air Velocity Measurement
- PAO/PAO HEPA Filter Integrity Test
- Particle Count Test
- Room Pressurization Test
- Airflow Visualization Test
- Light Intensity Test
- Air Exchange Rate
- Recovery Test
- Temperature and Humidity Test ( with and without Logger)
Air Velocity Measurement
- 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.
PAO/PAO HEPA Filter Integrity Test
- 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 (PAO) 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.
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 , 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.
Room Pressurization Test
- 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.