SOP for Fumigation in Production Area by Using 5 % Gramicid and Fogger

1.0 OBJECTIVE

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

2.0 SCOPE

This SOP shall be applicable for all the area of Production.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 Fumigation should be carried out at the end of the production operation twice in a month and whenever required.
5.2 Production person shall ensure that raw Material, 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.
5.3 Always use nose-mask and Goggles while doing fumigation as Gramicid is irritating to the human eye.
5.4 Windows, doors should be closed; AHU’s should be switched off before starting fumigation.
5.5 Place 5% Gramicid in the fogger and switch “ON” the fogger.
5.6 After fumigation of the area is complete, Switch “OFF” the fogger and affixed the label as “Area under fumigation, do not enter” on every side of the entrance. Allow the fumigation fumes to stay for about 6-7 hrs.
5.7 After the specified time of fumigation is over, enter the area only by starting exhaust for about 30 minutes.
5.8 Conduct cleaning before processing any product in the concerned area.
5.9 After 30 minutes, start the AHU’s allow to stabilize to attend required temperature and humidity then start the routine production operation.
5.10 Fill the “Fumigation Record”.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department

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