是，至少每年一次需要執行作業場所動/靜態的微粒子是否符合各級區的限量要求。執行的方法請參考ISO 14644-1的要求。請注意，ISO14644-1並沒有動/靜態之分， 例如PIC/S Annex 1所規定B級區的動態在ISO 14644-1為ISO 7等級，靜態為ISO 5等級。另外，USP <1116> MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS 的表一所規定潔淨室分級ISO 5、6、7、8都是動態的限量，沒有靜態標準。
 
如果是生產無菌產品潔淨室再驗證的頻率與項目請參考PIC/S GMP Guides Annex 1 Draft, 2020
4.34 The requalification of cleanrooms and clean air equipment should be carried out periodically following defined procedures. The requirement for requalification of cleanroom areas is as follows:
Table 3: Minimum test requirements for the requalification of cleanrooms
 

Grade	Determination of the concentration of airborne viable and non-viable particles	Integrity Test of Terminal Filters	Airflow volume measurement	Verification of air pressure difference between rooms	Air Velocity test
A	Yes	Yes	Yes	Yes	Yes
B	Yes	Yes	Yes	Yes	*
C	Yes	Yes	Yes	Yes	*
D	Yes	Yes	Yes	Yes	*

* performed according to a risk assessment documented as part of the CCS. However, required for filling zones (e.g. when filling terminally sterilised products) and background to Grade A RABS.
For Grade A & B areas, the maximum time interval for requalification is 6 months.
For Grade C & D areas, the maximum time interval for requalification is 12 months.
…

From TPDA
2021/6/2