Standard Operating Procedure For Ultra-Violet Rays Exposure Of Clean Room

by Pharmadocx Consultants

PURPOSE: To lay down procedure of cleaning room through the exposure of ultra-violet rays.

RESPONSIBILITY  :  Production Manager

INTRODUCTION :-Range of UV rays that kills micro organisms is  253.7 nm.  Ultraviolet

rays kill microorganisms by an exposure time of 30 minutes twice a day is recommended on the days when filling or manufacturing activities are going on inside sterile area.  There is no need to switch on the UV lamps when work is not going on inside sterile area.  UV lamps are located at the ceiling of rooms for maximum exposure. The exposure time is recorded in the log book.  Life of a UV lamp is mentioned in its catalogue in hours.  UV lamps should be discarded after recommended burning hours.  Every one working inside the sterile area is cautioned to look at burning UV lamps as this can cause eye problems.

Procedure :-

1.         Ensure that area is clean and there is no obstruction in the path of    UV rays.

2.         Batch solution, semi finished or finished products shall not be exposed to U.V. rays, they should be either removed or covered.

3.         Ensure that no one is working under U.V. lamps

4.         Switch on the U.V. lamps from 8.00 A.M. to 8.30 A.M. in the morning before manufacturing activities commence & in the afternoon from 1.00 p.m. to 1.30 p.m. during lunch break.  Flexibility in time is permitted provided that exposure duration is not reduced.

5.         Document all details about exposure in the log book.

Author: (Production Manager)Checked by: (QA Manager)Authorized by: (Director Administration)
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.

15 June 2023

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