SOP for Fumigation in Production Area

OBJECTIVE

To lay down the procedure of fumigation in the production area by using 5 % Gramicid and Fogger.

SCOPE

This SOP shall apply to all the areas of Production.

RESPONSIBILITY

Execution: Operator

Checking: Production Pharmacist & Above

ACCOUNTABILITY

HOD-Production / Assigned Designee

PROCEDURE

• Fumigation should be carried out at the end of the production operation twice a month and whenever required.
• The production person shall ensure that raw materials, finished goods, intermediates or in-process goods should not be present in the area of Fumigation. If present cover all the materials with polythene bags.

• Always use a nose mask and Goggles while doing fumigation as Gramicid is irritating to the human eye.
• Windows and doors should be closed; AHU's should be switched off before starting fumigation.

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• Place 5% Gramicid in the fogger and switch “ON” the fogger.
• After the fumigation of the area is complete, Switch “OFF” the fogger and affixed the label “Area under fumigation, do not enter” on every side of the entrance. Allow the fumigation fumes to stay for about 6-7 hrs.

• After the specified time of fumigation is over, enter the area only by starting the exhaust for about 30 minutes.
• Conduct cleaning before processing any product in the concerned area.
• After 30 minutes, start the AHU’s allow them to stabilize to attend to the required temperature and humidity then start the routine production operation.
• Fill out the “Fumigation Record”.

ABBREVIATIONS

SOP: Standard Operating Procedure

Q.A.: Quality Assurance

HOD: Head of The Department

REVISION HISTORY

Nil

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