Standard Operating Procedure of Fumigation in Production Area of Pharmaceuticals is describe in this post.
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1. PURPOSE
1.1 The purpose of this SOP is to describe the standard procedure of Fumigation to control microbial contamination.
2. SCOPE
2.1 The SOP is applicable to the Sterile Manufacturing and Filling Area of Liquid Injectable Section.
3. RESPONSIBILITY
3.1 Area Supervisor is responsible for conducting the activities as per SOP.
3.2 Production Officer is responsible for checking the activities as per SOP.
3.3 QA Officer is responsible for monitoring the activities as per SOP.
3.4 Production Manager is responsible to ensure implementation of this SOP.
4. MATERIALS & EQUIPMENTS
4.1 SS Bowl
4.2 Spatula
4.3 Safety goggles
4.4 Gloves
4.5 Face mask
4.6 Potassium Permanganate
4.7 Formaldehyde 35%
5. PROCEDURE
5.1 Fumigation should be carried out at the end of production operation once a week and whenever required.
5.2 Area Supervisor ensure that Raw Material, intermediates or in Process goods are not present in area of fumigation.
5.3 Before starting the fumigation, switch OFF the AHU.
5.4 Place SS Bowl in the manufacturing and filling rooms.
5.5 Put 15gm of potassium permanganate in the SS Bowl. Pour about 25ml of 35% Formaldehyde solution in a dish containing potassium permanganate.
5.6 Reaction takes place resulting in the formation of fumes.
5.7 Close the room immediately so that the fumes do not come out of the room.
5.8 After fumigation of area is complete, affixed the label as “Area Under Fumigation”, do not enter on every side of the entrance, allow the fumigation fumes to stay for about 8-12 hours.
5.9 After the specified time of fumigation is over, enter the area only by starting Exhaust For about 30minutes.
5.10 After 30minutes start the AHU and allow to stabilize to required temperature and Humidity.
5.11 Conduct cleaning before processing any product in the concerned area.
5.12 Precautions
5.12.1 Area exhaust/ blower, chiller and dehumidifier should be switched OFF during Fumigation.
5.12.2 Wear gloves, Wear full-face mask, Wear goggles for eyes protection as it is irritating to human eye.
6. REPORTING
6.1 Fumigation Record
7. REFERENCE DOCUMENTS
7.1 Micro SOP for Fumigation
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