Standard Operating Procedure For  Fumigation On Sterile Area

by Pharmadocx Consultants

PURPOSE:    .  To lay down procedure for fumigation of sterile area.

SCOPE: This procedure applies for the Sterile Area.

RESPONSIBILITY  :          1. Production Manager

                                                2. Factory Manager   

INTRODUCTION :-  Fumigation by Formalin is the most potent method to destroy micro organism. Fumigation is done by mixing formalin & potassium permagnate minimum exposure time is 6 hrs. It takes 30 minutes for the AHU to render the area free from fuones. 500 ml. Formaldehyde solution (37%) is required to disinlect   28m3 air.

PROCEDURE :- 1. Before commencing the procedure ensure that

(a) there is no person left in sterile area except the person performing the fumigation         

(b) There is no semi finished product solution in the sterile area.

(c) AHU has been switched off.

2 Take formalin in each container put pot permagnate & leave the air immediately.


4. After 6 hrs. once more operate AHU to remove fumes

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

             (Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

13 June 2023

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