PURPOSE:   

Manufacturing and other operational areas need regular cleaning and  disinfection, in order to remove spillage powders, dust and dirt.  Cleaning ensures avoidance of cross contamination and to maintain working environment tidy and safe.

SCOPE:

This procedure applies to the entire Non-Sterile area.

RESPONSIBILITY:

Area Supervisor

PROCEDURE:  

Floor Mops: Lint free sponge mops are used. Mop handles should be of metal or plastic.

Brooms: Nylon brooms are used in non-manufacturing area. Sweeping with a broom is 

Followed by wet swabbing.

Cleaning : Clean the powder spillage in compounding area with wet floor mops only. Do not use brooms to clean compounding area. After the process work is completed and also at the end of the day , clean floors with disinfectant solution as per the cycle. Use 1% v/v Lysol solution as disinfectant to clean the floor.

Preparation : Water spillage should be cleaned immediately. Rubber mop is used to clean Area preparation area. Cotton mop should not be used as it leaves behind cotton fibres, which may increase particulate contamination in the preparation area. Rubber stoppers and glass pieces if any are collected in a dustbin provided in the washing section. At the end of the day , floor is cleaned with 0.1% v/v Teepol solution and 1% v/v Lysol solution as disinfectant.

Sealing : Minimum of materials are stored in vial sealing area. Floor is cleaned daily with Room detergent solution as per cleaning cycle. Oil spillage if any, is wiped off immediately to prevent area contamination with 70% IPA.

Corridor and   :    Corridor and other operating areas are swept twice a day with soft Nylon broom. Other areas. Wet cleaning is done immediately after brooming. Rotate disinfectant agent every ortnight as in the sterile area. All glass panes in the non sterile manufacturing area are cleaned using  70% Isopropyl Alcohol. Cleaning agent Teepol Disinfectant used Isopropyl Alcohol   70% Lysol (i.e Cresol in soap)

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