Fogging of Microbiology Testing Areas
The control of microbial load on surfaces of production rooms/area, storage rooms, research, Biosafety labs and Clean rooms is an everyday challenge. Surface sanitization or disinfection of production equipment`s and rooms by wiping with chemicals not only is a time-consuming procedure, but also its efficacy and validation is very intricate. Alternatively, fumigation allows overcoming many critical aspects of wiping in both procedure and validation. The belief is that regular use of novel Fogging (disinfection techniques ) that can decontaminate the whole area will further reduce the number of environmental micro-organisms, which will in turn improve the quality of the product being produced, thereby reducing wastage and increasing profitability. Fogging of Microbiology is achieved using either a static, purpose-built system in a factory area with strategically placed nozzles or, more commonly, a mobile unit.
Fogging of Microbiology with Hydrogen Peroxide (H2O2)
Hydrogen peroxide is a clear, colorless liquid, and more viscous than water. It is most commonly available as a solution in water.
Objective of Fogging in Microbiology
To lay down the procedure for Fogging of Microbiology Testing Areas.
Scope Fogging in Microbiology
This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory.
Operation Procedure of Fogging in Microbiology
Perform the Fogging of Microbiology once in a week at the end of working hours, Perform the fogging on below mentioned areas on different days
- Sterility testing area
- MLT, Subculture room and MLT section corridor and Change room.
- Sterilization area
Make sure that the area is thoroughly cleaned before fogging, Close all the dampers,Switch off all the AHU.
Enter into the area to be fogged as per the SOP No. along with the fogger (Micro mist and Nanotech) filled with the required quantity of dilute disinfectant.
Fogging in Microbiology –Sterility testing area:
Switch off the interlocking of the sterility testing area. Enter into change room- as per the SOP for the area along with the fogger filled with dilute Virosil, Keep the doors between change rooms. Place the fogger in one corner of change room. Adjust the motor angle at 45˚C and the timer to 0.5 liter. Connect the power cord of the fogger to the mains and switch on the fogger and quickly move out of the room into the sterility room and close the door. Wait in the sterility room for the fogging to complete. As soon as the fogging is complete, quickly transfer the fogger from change room-4 to Sterile Buffer room and place similarly. Adjust the timer to around 0.7 liter. Connect the fogger power cord to the mains and switch on the mains and quickly move out of the room into the sterility test room. Wait for the fogging to complete. As soon as the fogging is complete, quickly transfer the fogger from Sterile Buffer room to Sterility test room and place it similarly. Adjust the timer to around 0.7 liter. Connect the fogger power cord to the mains and switch on the mains and quickly move out of the room into the Return Buffer room and close the door’s soon as the fogging is complete remove the fogger from the sterility test room and then place the fogger in change room. Keep the doors between Return buffer & Return A/L and Return A/L & Change room-1 open. Connect the fogger power cord to the mains and switch on the mains and quickly move out of the room into the Microbiology corridor and close the door. Place a tag “Area under Fogging” as per Annexure No on the entry door and leave the area undisturbed for overnight.
Fogging of Microbiology in MLT Section:
Switch off the AHU of the MLT Section, Enter into the MLT Section as per the entry SOP along with the fogger. Enter the Subculture room and place the fogger in one corner on a SS stool and connect the power cord of the fogger to the mains. Adjust the timer of the fogger to 0.5 liter and switch on the mains. Quickly move out of the room, close the door properly and wait in the change room till the fogging is completed. As soon as the fogging is completed quickly take the fogger out of the subculture room and then fog the MLT room using the same procedure. After the fogging is complete in the MLT room quickly take out the fogger from the MLT room and place it in one corner of the change room on a SS stool. Adjust the motor angle at 45˚C and the timer to 1.0 liter. Connect the power cord of the fogger to the mains and switch on the mains and quickly move out of MLT section. Place a tag “Area under Fogging” as per Annexure No. on the entry door and leave the area undisturbed for overnight.
Fogging of Microbiology in Sterilization area:
Switch off the AHU of the Sterilization area, Enter into the Sterilization area as per the entry SOP along with the fogger, Enter the Media decontamination room and place the fogger in one corner on a SS stool and connect the power cord of the fogger to the mains, Adjust the motor angle at 45˚C and the timer to 0.5 liter, Switch on the mains and quickly move out of the room, As soon as the fogging is completed quickly take the fogger out of the Media decontamination room and then fog the Media preparation room, following the same procedure, After the fogging of the Media preparation room, quickly take out the fogger and place in one corner of the sterilization room on a SS stool, Adjust the motor angle at 45˚C and the timer to 1.0 liter, Switch on the mains and quickly move out of the room, Place a tag “Area under Fogging” as per Annexure No. on the entry door and leave the area undisturbed for overnight, Dilute and use required volume of Virosil, Pour the prepared disinfectant solution in to the tank of fogger prior to entering the area to be fumigated, Operate the fogger as per SOP, Come out of the room using exit process of the particular area, Put the label as ‘Area under Fogging’. Keep the area under this condition for overnight, in the next day morning, switch on the AHU. Open the dampers, Enter the area as per respective entry procedure. Close all the doors. Remove the Fogging set and exit along with the set, Record the fogging details.
Dilution and Use Volume of Virosil for Fogging of Microbiology
|Name of the Area||Fogging
|Volume of fogging (ml)||Volume of WFI/ PW (ml)||Total Volume (ml)|
|Sterility Testing room||Virosil||150||600||750|
|Sterile Buffer room||Virosil||150||600||750|
|Change rooms-2, Change room-3 and Change room-4||Virosil||100||400||500|
|Return Buffer, Return A/L and Change room-1||Virosil||100||400||500|
|MLT A/L and Change room||Virosil||200||800||1000|
|Media decontamination room||Virosil||100||400||500|
|Media preparation room||Virosil||100||400||500|
|Sterilization area and Washing area||Virosil||200||800||1000|
4-Direction Fogger with compressed air for Fogging of Microbiology
1. Test the equipment with water only prior to any chemical use.
2. Place the chemical into a container of water for testing.
3. Open main supply air valve and adjust each nozzle valve to optimize to be fine fog.
4. Now ready for chemical fogging.
5. Run fogging as the controlling time.
6. When finished fogging, deactivate the air supply.
7. Follow other specific recommendation by the suppliers.
1. Connect air supply and at the bottom of stand.
2. Put the chemical tube into the chemical tank.
3. Preferable height shall be adjusted by using knobs and tightens the knobs to secure
Fogger (Electric motor Operated) for Fogging of Microbiology
1. With its powerful electric motor, fogger distributes the fine droplets evenly over the affected area and delivers a particle size between 5 to 40 microns. The needle dosage control knob allows a liquid output flow from a lowest output of 10 ml/min in the range to a maximum of 170ml/min to create heavy mist depending on the viscosity of the liquid to be fogged.
2. The only maintenance required is an occasional cleaning of the liquid filter and the PP filter. Remove the filter and rinse it with running water to remove the clinging particles.
3. Avoid contamination when changing chemicals: Fogging with clean water (or appropriate solvent) through unit and rinse tank thoroughly.
4. Periodically check the cleanliness of the air filter. If the motor does breathe a sufficient quantity of clean air, the fogging operation will be
inefficient and the motor could be overheated.
5. Check seal, gasket, tube and hose for leakage. Replace if necessary. Make sure the all the filters and solution filter are clean.
1. Make sure the plug (3) is disconnected from the power socket.
2. When you use the appliance for the first time or if you have not used it for a while, remove the closure ring and check the tank is clean.
3. Replace the power head, making sure the tank gasket is in place and return the closure ring to its position.
4. Pour the solution into the tank then close the filling cap, make sure the O-ring is in position.
5. Before connecting the power cord (3) to a power socket, make sure that flow control knob on close position
– Switch is set to the off position.
6. Aim the nozzle in the required direction and switch on the appliance.
7. Adjust to flow control knob for the quantity of product to be distributed.
8. When using solution which creates foam, to keep foam from penetrating into the power head to damage the motor , in any case, the foam level should be kept lower than the PE filter.
9. Plan your job in such a way that the appliance draws in as little fog as possible.
10. Work so that you leave the treated areas through untreated areas in the exit direction.
11. Once fogging is complete, close the control knob before switching off the appliance.
12. Remove residues of solution and empty tank, fog using warm water.
Difference between Fumigation and Fogging
Fumigation and fogging are very important processes in cleanroom area to minimize and control the microbial load. To keep the controlled area from being contaminated in pharmaceuticals, two processes namely fumigation and fogging are used. Both the processes are used for the same purpose, but the difference between fumigation and fogging in pharmaceuticals is great. Moreover, fumigation is banned in few pharmaceuticals because of its negative effects while fogging is a safer option than the former. In fumigation, formaldehyde solution is mixed with the potassium permanganate in a fixed proportion. While fumigation involves spraying formaldehyde and potassium permanganate in liquid form, fogging uses the mixture of hydrogen peroxide and silver ion solution to control the contamination. There are many different disinfectants used as the fogging solution but the above mentioned are most commonly preferred. As mentioned earlier, this is due to the negative side effects of fumigation. Other than the negative side effects, fumigation also requires a lot of cleaning up after the process is implemented. After the process of fumigation in the controlled area, there is a requirement of de-fumigation in that area too.