Standard Operating Procedure for Cleaning mopping and disinfection Prepared by: Microbiologist Approved by: Q. C.

Manager Reference: USP / SOP Guidelines

SOP #. Effective Date: Rev. #: Rev. Date: Page 1 of 3

Purpose
To lay down a standard procedure for Sterile Area Disinfection.

Scope
This procedure provides a standard method for routine cleaning of sterile area using Disinfectants to ensure the area is completely free from micro organisms.

Responsibility
Senior Chemist - Production Microbiologist, Supervisor - Production House keeping

Procedure
Remove all glass pieces if any, from sterile area after completion of the filling. Clean the filling Machine, SS parts, filling table and floor with distilled water. Use hot distilled water to remove the strain if present. Then use following disinfectants as per the schedule.

After cleaning, dry the sterile area for half an hour. The Machine, table, laminar airflow should be wiped with decontaminating solution: Decontaminating solution contains: Liquid phenol 5% w/v Formaldehyde 8% v/v IPA 75% v/v Distilled water QS Spray the hydrogen peroxide solution 20% w/v after cleaning and wiping. Finally, fumigate by using Formaldehyde and Potassium permanganate.

Record
Log Book