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空調系統年度再驗證

#1
QQ 發表於 2021 / 05 / 07
空調系統年度再驗證-空氣微粒項目是否需要執行作業場所動/靜態各一次?
管理員回覆
您好,
 
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

 

 

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