STERILE AREA DISINFECTION
1. Objective:To lay down a standard procedure for Sterile Area Disinfection
2. 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.
3. Responsibility:· Senior Chemist - Production· Supervisor - Production.· House keeping
4. Procedure:4.1. Remove all glass pieces if any, from sterile area after completion of the filling.4.2. Clean the filling Machine, SS parts, filling table and floor with distilled water.4.3. Use hot distilled water to remove the strain if present.Then use disinfectants as per the schedule.
4.1. After cleaning, dry the sterile area for half an hour.4.2. The Machine, table, laminar airflow should be wiped with decontaminating solution.Decontaminating solution contains:Liquid phenol 5% w/vFormaldehyde 8% v/vIPA 75% v/vDistilled water QS4.3. Spray the hydrogen peroxide solution 20% w/v (Virosil Pharma) after cleaning and wiping.4.4. Finally, fumigate by using Formaldehyde and Potassium