Clean Room Validation Tests

What is a Clean Room? What are Cleanroom Validation Tests?

Clean room; Air conditioning and filtration systems in which contaminants are kept to a minimum in the sterile product environment, environment, air, wall, ceiling and all surfaces can be defined as specially designed rooms kept under continuous pressure.

Clean room tests; It is carried out in all industrial clean rooms, operating rooms, intensive care rooms where medical and sterile products are produced.

Clean room performance varies depending on the particle concentration in the room. In clean room design, requirements such as temperature, humidity, living and non-living pollutants, air flow directions and pressure must be met completely.

Classification of the clean room varies depending on the production to be made in the room. HVAC design is carried out in line with the determined classification.

TS 11605 EN ISO 14644-1 Clean rooms and the environments controlled together in these rooms Part 1 - "Clean Room Validation Tests" performed within the scope of the standard for classification of air cleanliness are as follows.

- Measurement of Air Flow, Air Flow Rate and Uniformity
- HEPA Filter Leakage Test
- Particle Counting and Classification of Clean Rooms
- Differential Pressure Measurement
- Temperature and Humidity Measurement
- Visualization of Air Flow Characteristics
- Decontamination / Recovery Test

CLICK FOR MEDICAL PRODUCT ANALYSIS.