Cleanroom Validation

We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us.

USOARA ENGINEERING SOLUTIONS performs the HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.

Cleanroom Certification

validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:

Monitor And Control

A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.

Statistical analysis for cleanroom parameters is encouraged as a tool for monitoring the cleanroom after certification to ensure compliance. The tool of choice is statistical process control, SPC.

Methods for evaluation and measurements for Certification are specified in ISO14644-3. It calls out for the following ten tests.

• Air flow Test & ACPH Calculations

•  Installed Filter System Leakage Test (using PAO)

•  Non-Viable Particle Count Test

•  Recovery Test

•  Air Flow Pattern Test (Using Water Fogger/ Dry Ice/ FLR-20 )

• Air Pressure Balancing

•  Temperature & RH Measurement

Once certified to a particular class the cleanroom factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control.

Usoara Engineering Solutions carries out following tests to validate clean rooms/clean zones.

Air flow Test & ACPH Calculations

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. Air Exchange Rate tests determine the total air volume get in to the room within a clean room. The use of TSI Accubalance Air Capture Hoods of Model No.8380-B, assures accurate test results. The hood measures air volume flowing through registers, diffusers and grills. Weighing just 3.5 kg, 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.

Installed Filter System Leakage Test (using PAO)

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 (DOP) 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.

Non-Viable Particle Count Test

We are USOARA ENGINEERING is a reputed name in offering clean room validation services. 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.

Recovery Test

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 ultimate 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.

Air Flow Pattern Test (Using Water Fogger )

We offer Airflow Visualization Test as a part of the vIalidation 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

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.

Containment Test

We conduct Containment Tests for client's clean room facility. The test is carried to demonstrate that airborne contamination does not enter from a higher pressure area adjacent to the clean room by means of leaks in the construction materials. The test is conducted by trained and experienced technicians using modern instruments that assure accurate results.

Temperature & RH Measurement

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.