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.

3. Put a board AREA UNDER FUMIGATION.

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

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