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Standard Operating Procedure (SOP) for Fumigation of the Production area by using Virosil at pharmaceutical drug manufacturing plants.

Fumigation in Production Area

1.0   PURPOSE:

• • To lay down a procedure for the fumigation of the production area.

2.0   SCOPE:

• • This standard operating procedure is applicable to the production area in pharmaceutical drug manufacturing plants.

3.0   RESPONSIBILITY – SOP FOR FUMIGATION:

• • The operator or Technician of the production department shall be responsible for the fumigation of the area as per instructions written in this SOP.

• • Officer or Executive of the production department shall be responsible for fumigation of the area as per instructions are written in this SOP.

• • Engineering Operator or Technician or Officer or Executive shall be responsible for the start and stop of AHU’s of the area under fumigation as per instructions written in this SOP.

• • Head of the department/designee of respective areas, Engineering & QA shall be responsible for compliance of this SOP.

4.0   ABBREVIATIONS – SOP FOR FUMIGATION:

• • AHU: Air handling unit

• • CCR: Change Control Record

• • ml: Millilitre

• • NA: Not Applicable

• • QA: Quality Assurance

• • SOP: Standard Operating Procedure

5.0   DEFINITION:

• • SOP: A written authorized procedure, which gives instructions for performing operations.

• • Production area: Production areas include the areas in which core manufacturing as well as packing activities are being done (i.e. Granulation, compression, coating, capsule filling and primary packing cubicles).

6.0   PROCEDURE – SOP FOR FUMIGATION:

• Precautions:

• • Wear hand gloves, goggles, and nose masks during the preparation and fumigation process.

• • No manufacturing/packaging activity shall be carried out during the process of fumigation and cleaning.

• • Ensure the doors of areas/rooms are properly closed during the fumigation process.

• • Never operate the fogging machine when the fogger tank is empty.

• • Consume freshly prepared solution on the same day. After use, the leftover solution shall be discarded.

• • Keep the direction of the fumigator nozzle in the upward direction before use.

• • Wash the hands thoroughly after handling the solution.

• Arrangement of fumigator:

• • Fumigation shall be carried out with the Ultra-low volume (ULV) Fogging machine.

• • The fogging machine shall be placed on the turntable.

• • The angle of the spray nozzle shall be kept at 45 degrees (Approximately) to the ground which can be adjusted with the adjustment knob as per requirement for the target area.

• Preparation of fumigation agent:

• • Prepare 20% v/v Virosil solution (Hydrogen peroxide with Silver nitrate) by diluting 400 ml of Virosil in 1600 ml of purified water for 2 liters of solution or equivalent (validated fumigation solution).

• • Record the details of fumigating solution preparation in annexure 1.

• Procedure for Fumigation

• • Wrap all the equipment, containers, raw/packing material pallets, and power supply panels in the respective area with cling film or polybag.

• • Intimate to the Engineering Department to close the fresh air damper and exhaust damper completely

• • Switch off the AHU approximately 15 minutes before the start of fumigation.

• • Fill in fogger tank with freshly prepared 20% v/v Virosil solution.

• • Bring the fumigator to the room/area where fumigation is to be carried out, attach it to the power supply and leave the room with the fumigator ‘ON’ and close the door.

• • Keep the flow rate at a minimum and continue the fogging for 10 minutes.

• • After 10 minutes, enter the room and switch off the fumigator. Carry the fumigator to the next area/room for fumigation.

• • Ensure that proper mist is created in the area, so that the active ingredient of virosil or any validated fumigation agent is suspended in the atmosphere, thereby giving complete aerial disinfection

• • Keep the area under fumigation for not less than 4 hours or overnight.

• • Follow the above steps for the fumigation of all the areas in the respective blocks/areas.

• • Record the activity in the respective area and equipment usage log book.

• Frequency:

• • After area shutdown.

• • After major civil modification in the area.

• • If microbial count of area found more than alert limit or as and when required.

• Defumigation:

• • After four hours or overnight of fumigation activity, switch on the air handling units of area.

• • Clean all the areas as per respective area cleaning SOP.

• • Clean all the equipment before use as per their respective SOP’s.

• • After attaining the required temperature and relative humidity, take line clearance and then start the activities. (As applicable)

• Cleaning and disinfection:

• • Enter in to the de-fumigated area, disconnect the plug from the main power supply and carry the fogging machine to washing area for cleaning.

• • Add approximately half litre of purified water into the tank of fogger machine.

• • Run the machine for two minutes by keeping the direction of the fumigator nozzle in the upward direction to remove the traces residue of the fumigant used.

• • Clean the outer body of the fogger with lint-free cloth wetted with purified water.

• • Carry out the cleaning and disinfection of the floor with the Disinfecting agent as per the respective SOP.

• Destruction of excess quantity of fumigating agent:

• • After fumigation of area transfer the container of fumigating agent to washing area.

• • Add potable water in to container of fumigating agent (Example: If a container filled one fourth with fumigating agent then add potable water to make it more than half).

• • After dilution drain it in to wash area drain followed by flushing of drain with water.

7.0   ANNEXURES – SOP FOR FUMIGATION:

Annexure I: Record for Preparation of Fumigating Agent.

Prepare the log with the following table contents…

• • Date

• • Fumigating agent

• • Quantity of Fumigating agent taken

• • Quantity of Purified water taken

• • Qty. of fumigating  solution prepared

• • Prepared By

• • Checked By

• • Qty. of fumigating solution used

• • Qty. of fumigating solution destroyed

• • Destroyed By

• • Checked By

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