Cleanliness - number of dust particles
Differential pressure
1. The pressure difference between rooms in adjacent clean areas should be 10-15 PASCAL (guideline value). -- EUCGMP (EU)
2. The pressure difference between clean area and non-clean area, between different levels of clean area should not be less than 10 PASCAL, the same cleanliness level of different functions should be maintained between the operation of the appropriate pressure gradient, in order to prevent pollution and cross pollution. - the new GMP
3. The pressure difference between rooms in adjacent clean areas should be 12.5 pascals. --FDA
Airflow organization and self-purification
The various airflow modes should be shown to be free from the risk of contamination. For example, appropriate measures should be taken to ensure that airflow does not blow particles from operations or equipment and operators towards areas of high cleanliness requirements.The clean area should meet the "static" standard after all production operations are completed and the operators leave the site and clean themselves for 15-20 minutes (guidance value).
Cleanroom retaining structure
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