SOP ON FOGGING IN MICROBIOLOGY LAB
PURPOSE: To provide a procedure for Fogging in the Microbiology Lab.
SCOPE: This procedure is applicable for Fogging in the Microbiology Lab.
CROSS-REFERENCE DOCUMENTS: Entry and Exit procedure in microbiology Lab.
ATTACHMENTS
Fogging Solution Preparation and Usage Record
Fogging Agent Receiving & Consumption Record
Intimation For AHU On/Off
DEFINITIONS
Fogging: Fogging is a process in which a fogger generates the vapors of disinfectant in the area to reduce the microbial load present in the air and surface of any object.
Disinfectant: Disinfectant is a chemical or the composition of the chemicals which used to reduce the microbial load to a significant level. A wide range of disinfectants are available which are being used as surface sanitizers as well as air fumigants. As per USP chapter <1072> at least 3 log reduction for vegetative forms of bacteria and fungi is required. On the other side, for Bacterial spores, at least 2 log reduction should be achieved while treating on the surface of any object.
RESPONSIBILITY:
Quality Control Department Laboratory Attendant Person (Microbiology Lab)/ Designee: follow this procedure during fogging in the Microbiology Lab.
Head-QC /Designee: To ensure the activity as per SOP & implementation of SOP.
Head-QA/Designee: To ensure the implementation & compliance of the defined system
Plant Head/ Designee shall be responsible for To ensure the implementation of the procedure.
PROCEDURE:
SAFETY/PRECAUTION/EHS
Ensure the cleaning of the area before fogging.
AHU shall be in OFF condition before 10 minutes of the fogging.
After completion of the fogging activity, AHU shall be in off condition for at least 1 hour.
The room shall be closed and no movement is allowed at least 1 hour after fogging.
Use proper safety such as gowns, hand gloves, Nose masks, and safety goggles during fogging.
Do not enter the area till the area gets completely de-fogging.
Safely operate the fogging machine as per its operating procedure.
Procedure
Preparation of Fogging Solution
20% Silvicide solution shall be used for fogging in the microbiology Lab.
The fogging agent shall be received by a Micro person along with a certificate and after verification of the physical condition of the container shall be recorded the details.
In case of material/ condition of the Containers is physically compromised, the same shall not be received and sent back to the vendor.
20% Silvicide Solution shall be prepared.
Silvicide solution shall be prepared in purified water as per the required volume for the day.
Other suitable qualified air fogging disinfectant solutions may also be used with the recommended concentration of the manufacturer.
After Preparation of fogging solution shall be filled in to the fogging machine.
Intimate to the engineering department to put OFF the AHU before the fogging.
Before starting the fogging instrument shall be covered with a polybag if required.
Before keeping the fogger in the pass box, surface sanitization of the Fogger shall be done with 70% IPA and allowed to stay under UV light for 15 minutes.
After off the AHU, Connect the Power supply of the fogger to the main electric supply and switch ON the main supply.
Operate the Fogger at a fixed speed and use the required fogging solution.
Adjust the blower of the Fogger machine at approximately 45°.
Switch ON the Toggle of the fogger machine.
After completion of fogging switch off the fogger machine and record the details.
Affix the label “AREA UNDER FOGGING”.
Close the door and hold the area under fogging for at least 1 hour.
Allow the fogging fumes to stay for contact time.
Inform to Engineering department to run the AHU for defogging the area.
Intimate the engineering department to put ON the AHU after contact time.
Enter the details of fogging.
Discard the leftover solution (if any) in the washing area.
Clean the tank of the fogger with Purified water and dry it with lint free wipe.
Wipe the external surface with a clean lint-free wipe.
Determine the volume of the area to be fogged
Step-1: Determine the volume of space to be fogged
The total volume of room to be fogged = Length x Width x Height (ft3)
Step 2: Calculate the total quantity (volume) of fogging agent required for the area:
Note: 400 ml Silvicide solution (20% v/v) is required to fog 1000 ft3 area
So required volume of fogging agent (ml.) = Volume of room (ft3) x 400/1000
Step 3: Calculate the total fogging time:
Time required (minutes) = Total liquid to be fogged / flow rate.
For Example:
For Sterility Room required disinfectant = 488.8 X 400 /1000= 195.52 ml =equivalent to 200 ml Required Fogging Time = 200 /100 = 2 minutes
Table II Required Volume of Disinfectant Area Wise with Fogging Time
| Area | Area Volume (ft3) | Disinfectant Required (ml) | Approx. Volume (ml) | Flow Rate
(ml/min) |
Total Time |
| Sterility Room | 488.8 | 195.52 | 200 ml |
100 |
2 min |
| Cooling Zone | 270.0 | 108 | 100 ml | 1 min | |
| Sterile Corridor | 229.5 | 91.8 | 100 ml | 1 min | |
| Sterility Air Lock I | 182.2 | 72.88 | 100 ml | 1 min | |
| Sterility Air Lock II | 195.9 | 78.36 | 100 ml | 1 min | |
| Sterility Air Lock III | 197.7 | 79.08 | 100 ml | 1 min | |
| Sterility Air Lock IV | 81.0 | 32.4 | 50 ml | 30 sec | |
| Sterility Air Lock V (Exit) | 183.9 | 73.56 | 100 ml | 1 min | |
| MLT Room | 433.1 | 173.24 | 200 ml | 2 min | |
| Culture Testing Room | 433.1 | 173.24 | 200 ml | 2 min | |
| Media Plate & Disinfectant Prep. Room | 762.8 | 305.12 | 300 ml | 3 min | |
| Corridor (MLT & Media Plate Prep. Room) | 324.0 | 129.6 | 150 ml | 1.5 min | |
| Air Lock I (MLT Room) | 204.4 | 81.76 | 100 ml | 1 min | |
| Air Lock II (MLT Room) | 206.3 | 82.52 | 100 ml | 1 min | |
| BET Room | 285.0 | 114 | 100 ml | 1 min | |
| LBPC Room | 292.5 | 117 | 100 ml | 1 min |
Fogging Frequency:
| Area | Frequency | |
|
Sterility area |
Airlock-1 |
Daily or whenever required |
| Airlock-2 | ||
| Airlock-3 | ||
| Airlock-4 | ||
| Airlock-5 | ||
| Sterility corridor | ||
| Cooling Zone | ||
| Sterility Room | ||
| MLT Room, Culture Testing Room, and Disinfectant Filtration Room | Airlock-1 |
Weekly or whenever required |
| Airlock-2 | ||
| MLT/CT corridor | ||
| MLT room | ||
| Culture Testing Room | ||
| Disinfectant Prep. Room | ||
