Many have fallen into the trap of spending huge amounts of money building a cleanroom with little thought and understanding of what is required to get it up and running and the subsequent maintenance of it.
The Cleanroom Performance Testing (CPT) OR Validation require time and patience to understand process requirement. The scientific way of qualifying cleanroom operations conducting CPT ensures that the cleanroom is controlled from the start, that the process within the room is not posing a risk to the environment that personnel working within the cleanroom are following protocol, and that products manufactured or processes performed within it will be consistently and reproducibly safe and of the highest quality.
All the Cleanroom performance tests are mostly based on the following internationally accepted standards and recommended practices such as:
- ISO 14644-3 : Cleanrooms and associated controlled environments Part 3: Metrology and test methods
- IES-RP-CC006.3 : Testing Cleanrooms
- NEBB Procedural Standards : Procedural Standards for the Certified Testing of Cleanrooms
| Course Content: |
| PLANNING STAGE |
FIELD PERFORMANCE |
| Review Design Documents |
Air Handling Unit Performance Test |
| Scope of validation |
Air Balancing to verify air change rates |
| Validation Master Plan |
Airflow velocity & Uniformity |
| Standard Operating Procedures (SOPs) |
Air Balancing / Air Pressure Difference Test |
| Approaches to validation |
Filter leakage tests to verify filter integrity |
| Calibration and verification |
Containment leakage to verify absence of cross-contamination |
| Qualification and validation protocols |
Recovery to verify cleanup time |
| Relationship between validation and qualification |
Airflow visualization to verify required air flow patterns |
| Qualification and validation reports |
Airborne particle count for classification |
| Qualification stages (DQ, IQ, OQ, PQ & Change control) |
Temperature & Humidity test |