sop for Fogging in Sterile and Non Sterile Area
1.0 OBJECTIVE:
To lay down a procedure for Fogging in Sterile and Non Sterile Area.
2.0 SCOPE:
This SOP is applicable for Fogging in Sterile and Non sterile Area using Fogging Machine
3.0 RESPONSIBILITY:
Officer/Executive Production
4.0 ACCOUNTABILITY:
Head Production
5.0 PROCEDURE:
5.1 Check & ensure that the area intended for fogging is completely closed.
5.2 Silvicide shall be used as Fogging Agent.
5.3 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).
5.4 Fogging with 20% Silvicide Solution shall be performed in the particular Area.
5.5 After Fogging, leave the Area in Static Condition up to one hour for complete sanitization.
5.6 Area should be fogged with defined time which is mention in Annexure-I, Titled “Fogging Solution Usage Record”.
5.7 Clean the Area and Equipment before starting of any activity with scheduled Disinfectant Solution for the day.
5.8 Record the Fogging details in Annexure-II, Titled “Fogging Record (Grade A & B)” for First floor,
Annexure- III, Titled “Fogging Record (Grade A & B)” for Second Floor, and Annexure-IV, Titled “Fogging Record (Grade C & D) for First and Second Floor”.
5.9 Frequency:
5.9.1 For Grade A & B: Daily and after Operation
5.9.2 For Grade C & D Weekly ± 1
Fogging frequency may be increased on the basis of Environmental Monitoring Report of the said Area.
a) Shut Down
b) Microbial Count (Beyond Limit).
6.0 ABBREVIATIONS:
SOP :Standard Operation Procedure
S. No. :Serial Number
Ltd. :Limited
No. :Number
QA :Quality Assurance
QC :Quality Control
Cu. Ft. :Cubic feet
7.0 ANNEXURES:
Annexure-I :Fogging Solution Usage Record
Annexure-II :Fogging Record (Grade A & B) for First Floor
Annexure-III :Fogging Record (Grade A & B) for Second Floor
Annexure- IV : Fogging Record (Grade C & D) for First and Second Floor
8.0 DISTRIBUTION:
• Controlled Copy No. 01 :Production Department
• Master Copy : Quality Assurance Department
9.0 REFERENCES:
In House
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area