Clean Room Validation

Clean Room Validation

Clean Room Validation

Clean room validation is the process of verifying and documenting that a clean room facility meets the required cleanliness standards for its intended use. Clean rooms are specialized environments used in various industries, such as pharmaceuticals, biotechnology, and electronics manufacturing, to maintain a sterile or low particulate environment.

Clean room validation typically involves a series of tests and measurements to assess the cleanliness of the environment, including air quality, particle counts, and microbial counts. These tests are conducted using specialized equipment, such as particle counters and microbiological samplers, and are carried out at various locations within the clean room.

The results of these tests are compared against predetermined cleanliness standards, such as ISO 14644 or US Federal Standard 209E, to determine whether the clean room meets the required standards. If the results indicate that the clean room does not meet the required standards, corrective actions are taken to address the identified issues.

Clean room validation is a critical process that ensures the safety and quality of products manufactured in a clean room environment. It provides assurance to manufacturers, regulators, and consumers that the products are produced in a controlled and sterile environment, reducing the risk of contamination and ensuring product quality and safety.

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 ISO 14644-3. 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)
  • Air Pressure Balancing
  • Containment test
  • Temperature & RH Measurement
  • Light Intensity Measurement
  • Sound Level 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.

Accurate Labs carries out following tests to validate clean rooms / clean zones.

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.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 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.

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.

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.

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

Instruments Which Can Be Calibrated:
  • Airflow balancing
  • Fuming Hoods
  • Point Exhaust tests
  • Personnel safety exhausts verification
  • Leak detection in ducts
  • Pressure balancing between rooms and spaces

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.

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.

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.

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.

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.