Contact Info
-
-
- Phone +91-141-4046599
- Mobile +91-98297-46596
- info@cegtesthouse.com
-
Ask The Expert
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:
- Process Validation
- Equipment/Area/System Validation
- Analytical Method Validation
- Cleaning Validation
- Personnel 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
- Temperature
- Relative Humidity
- Heating and Cooling Capabilities of the Room
- Sound Levels
- Lighting Levels
- Vibration Levels