Clean Room Testing & Validation
Pharmintech offers a gamut of Calibration & Validation services 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.
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. 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:
Clean Room laminar flow tests
- Airflow balancing
- Fuming Hoods
- Point Exhaust tests
- Personnel safety exhausts verification
- Pressure balancing between rooms and spaces
- Leak detection in ducts
Light Intensity Test
The purpose of the lighting level tests 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 measure the sound pressure. The measurements will vary based on the occupancy state-of-the-art clean room. The purpose may vary but the procedures of testing are identical.
Air Exchange Rate
Air Exchange Rate tests determine the total air volume get into 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 execute recovery tests for clients across Industries. These tests demonstrate the ability of the clean room 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. The test is conducted by experienced technicians from team. Our technicians have enriching experience and provide clients with high quality service. The goal of our company is to assure complete satisfaction of clients through effective execution of services and by providing best array of clean room equipment. We ensure that client's clean room facility is performing properly and accurately.
Temperature and Humidity Test
We conduct validation tests that include Temperature and Humidity Measurements / Tests. Two levels of temperature and 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.