Clean Room Validation

clean room validation

A Cleanroom is designed to monitor, control & maintain the environment of the room. It helps in preventing contamination from dust, microbes, vapor, fibers, or any other sources. Cleanrooms are of absolute importance to various industries, including Life Sciences, Food Manufacturing, Automotive & High-Tech Semi-Conductor industries, ensuring that the products manufactured are free from contamination, and that the processes are error-free & develop products of the highest class.

According to the FDA, the goal of validation is to: “establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product, meeting its predetermined specifications and quality attributes.”

CEGTH offers its unparalleled range of Clean Room Validation services to varied industries. The classification of validation, depending on time & frequency to perform, related to production, are as follows:

  • check-mark-1Process Validation
  • check-mark-1Equipment/Area/System Validation
  • check-mark-1Analytical Method Validation
  • check-mark-1Cleaning Validation
  • check-mark-1Personnel Validation
Our Environment Testing Laboratory Specializes in Complying with ISO 14644 through the following Parameters:
Test Parameter Objective Maximum Time Interval Test Procedure and Key Aspects
Particle Count Test Verifies Cleanliness 6 Months or 12 Months Depending on Class Particle Counter. Readings and Positions
Air Pressure Difference Absence of Cross-Contamination 12 months Measure Pressure Difference
Airflow Volume Verifies Air Change Rates 12 months Measure Supply and Return Air, Calculate Air Change Rate
Airflow Velocity Verifies Unidirectional Airflow and/or Containment Condition 12 Months Velocity Measurement
Filter Leakage Verifies Filter Integrity 12 months Filter Media and Filter Seal Integrity
Containment Leakage Verifies Absence of Cross-Contamination 12 months Airflow Direction and Pressure Differential
Recovery (time) Verifies Clean-up Time 12 Months Time Taken Maximum 15 Minutes
Airflow Visualization Verify Required Airflow Patterns 12 months Airflow Direction, Documented Evidence
Additional Tests
  • check-mark-1Temperature
  • check-mark-1Relative Humidity
  • check-mark-1Heating and Cooling Capabilities of the Room
  • check-mark-1Sound Levels
  • check-mark-1Lighting Levels
  • check-mark-1Vibration Levels