Clean Room Validation

Cleanroom Validation Services

Cleanroom Validation Services

Pharmintech offers a gamut of Calibration & Validation services for equipments & Clean room facilities based on the thorough understanding of cGMP standard.

We are providing to vast range of services to concern for clean room validations by our panels of specialists with us.

We perform validations as per ISO 14644, EU cGMP, US Federal Standard 209E, USFDA, guideline for all rooms classification.

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
  • Molecule Counts Testing
  • Room Pressurization Test
  • Airflow Visualization Testing
  • Power strength Analysis
  • Air Exchange Rate
  • Containment Test
  • Recovery Test
  • Temperature and Humidity Test

Air Velocity Measurement:

We provide air speed measurements and tests to decide the normal filters confront speed and consistency, and the normal room wind current speed and consistency inside a perfect room. Clean room ahu manufacturer, supplier and exporter services with system, pharma, area validation and designed in Mumbai India. The normal wind stream speeds are figured by isolating the aggregate of the air flow grille speed by the quantity of readings given.

DOP/PAO HEPA Filter Integrity Test:

Our company manufacturers of entire HEPA/ULPA filtering respectability test service. We are offering for pharmaceutical and microelectronics enterprises. All filters honesty testing performs by our services as per the IES-RP-CC-001-86 and ISO 14644 standards. We are preparing to effect HEPA filters integrity test with all Octal Phthalate (DOP) and Poly Alpha Olefin (PAO) contingent upon customer office's particular demands. Clean room ahu manufacturers, suppliers and exporters services with system, pharma, area validation and designed in Mumbai India. We provide assured to tests guarantee to client's filtering is in conformity with differ principles and additionally overseeing organization prerequisites. Legitimate documentation and affirmation given by us and we also likewise predicts potentially execution issues and expands filters life.

Particle Count Tests:

Our molecule add test gives complete airborne atom examine simplicity groupings. We are performed to decide the genuine molecule counts levels inside the office at the season of the tests. The test recognizes molecule rely on premise. The molecule size(s) of intrigue, the room inhabitancy states and the clean room validation grouping will be well known preceding the start of the test and will be as determined in the URS records

Room Pressurization Test:

We conduct Room Pressurization Test for industrial clean rooms equipments. As a part of the validation process, this test verifies that a pressure differential meet the specified requirements.

Airflow Visualization Test:

We are offering air flow visualizations tests as per a parts of the approval procedure. Representation has completed by utilizing water fogger and taking video graphs. The reason for the wind stream perception tests is to demonstrate the clear air stream design all through the unidirectional clean rooms. Clean room validation services with system, pharma and designed in Mumbai India. The tests can likewise be utilized to show the effect for air flow originated by equipments. It is superior to performance these tests after air flow speeds and consistency test and room pressure test has been achieved. The tests are deciding the air current examples inside a room utilizing ISO 14644 guideline. This visual observing services are imperative in:

  • Clean Room Laminar Air Flow
  • Air Flow Balancer
  • Cleanroom Validation Services
  • Points Exhausts test
  • Personnel protection exhaust verifications
  • Pressure balance betweens room and space
  • Leakage detections in duct

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.

Containment Test:

We direct Containment Tests for client's perfect room office. The test has conveyed to show that airborne contaminations do not go into from advance pressures region besides the clear rooms by methods for spills in the development material. The tests are led via prepared and experienced specialists utilizing current instrument that guarantee precise result.

Temperature and Humidity Test:

We performances approval tests that incorporate temperatures and humidity measurement Test. We provides analysis of temperatures and humidity’s test has utilized by us relying upon the requirements. In the principal level, general temperatures and stickiness consistency has tried. The first level test has utilized to guarantee that the fine room's HVAC systems keeps up the predefined level of temperatures and humidity’s required for inhabitant comforts. Our company provides levels testing distinguished that the spotless room HVAC system need to keep up the describe level of temperatures for user comforts to controls system.

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