sop for Fogging in Aseptic and Non Aseptic Area
1.1 To lay down a procedure for Fogging in Aseptic and Non Aseptic Area.
2.1 This SOP is applicable for Fogging in Aseptic and Non Aseptic Area in Injection Parenteral
3.1 Officer / Executive Production
4.1 Head Production
5.1.1 Operator/Staff/Helper shall be wear goggles during fogging and leave the area after start the fogger.
5.1.2 Area AHU should be OFF before 5 min of fogging and should be start after 30 min of fogging.
5.2 Check & ensure that the area intended for fogging is completely closed.
5.3 Silvicide shall be used as Fogging Agent.
5.4 20% Solution of Silvicide in WFI shall be used as Fogging Solution. (For 1000 cu. ft. Area to be fogged
with Fogger – 200 ml of Silvicide in 800 ml WFI to be used).
5.5 Fogging with 20% Silvicide Solution shall be performed in the particular Area.
5.6 After Fogging, leave the Area in Static Condition up to one hour for complete sanitization.
5.7 Area should be fogged with defined time which is mention in Annexure-III, Titled “Fogging Solution Usage Record”.
5.8 Clean the Area and Equipment before starting of any activity with scheduled Disinfectant Solution for the day.
5.9 Record the Fogging details in Annexure-I, Titled “Fogging Record of Aseptic Area and Annexure-II, Titled “Fogging Record of Manufacturing/Washing & Sterilization/Unit preaparation
5.10.1 Daily and after Operation
Fogging frequency may be increased on the basis of Environmental Monitoring Report of the said Area.
Microbial Count (Beyond Limit)
|Sr. No.||Abbreviation used||Full form of Abbreviation used|
|1.||SOP||Standard Operation Procedure|
|3.||WFI||Water for Injection|
|4.||Sr. No.||Serial Number|
|7.||Cu. Ft.||Cubic feet|
7.0 ATTACHMENTS (ANNEXES) :
Annexes-I : Fogging Record
Annexes-II : Fogging Record of Manufacturing/Washing and Sterilization/Unit preaparation.
Annexes-III : Fogging Solution Usage Record.
|S. No.||Reference Title|
FOGGING RECORD OF ASEPTIC AREA
Department: Production –Fogging Agent:
Frequency: Daily and after operation
|Ampoule Filling –I
|Air Lock -IV|
|Air Lock -II|
|Air Lock –V|
|Air Lock -I|
FOGGING RECORD OF MANUFACTURING/AMPOULE WASHING/UNIT PREPARATION
Department: Production Area:
Month: Fogging Agent:
Year: – Frequency: Weekly ±1Day
|Date||Area||Fogging Time||Done By
Sign & Date
Sign & Date
Annexes-III : Fogging Solution Usage Record