Frequency of integrity testing for high-efficiency filters in the automatic double-door cargo washing room
According to GMP, cleanroom acceptance standards and common industry practices, the frequency is divided into the following levels. You can directly follow and implement them:
1. Routine usage frequency (most commonly used)
Test once every 6 months
Applicable to: cargo washing rooms in electronic, food, and ordinary pharmaceutical cleanrooms.
2. High-purity clean environment
Test once every 3 months
Applicable to: sterile drugs, medical devices, biological laboratories, high-level cleanrooms (10,000-level / 10,000-level / 100-level).
3. Immediate testing situations (no fixed cycle)
Test immediately if any of the following conditions are met:
High-efficiency filter has just been replaced or installed
The cargo washing room box or high-efficiency filter has been disassembled, moved, or collided
Pressure difference is suddenly abnormal (too high / too low)
The particle count in the clean area exceeds the standard, suspecting it is a filter problem
Water leakage, moisture, mold, chemical contamination
After a long shutdown, reactivation
4. Industry’s lowest mandatory requirement
New installation acceptance: 100% leak testing must be conducted
After normal use: At least once a year for integrity testing