Gowning and Degowning Sterile Area is an important factor of quality assurance of pharmaceuticals department.

Gowning and Degowning Sterile Area  Objective:

An important factor of quality assurance is wearing a prescribed clean and sterilized uniform when entering the cleanroom.

Heigher Enviromental Grade Uniforms Consist Of:

Company approved and provided under garment.

Sterile hood.

Sterile surgical mask

Sterile coverall

Sterile designated safety shoes

Sterile gloves

Safety glasses

Gown Up

Step 1

Wash hands thoroughly using bactericidal soap and dry thoroughly.

Wear first pair of sterile gloves following aseptic technique by touching only the inside of the gloves.


FLOOR MOPS   Lint free cloth uniforms

                        Rubber mops & lint free cloth are used to clean 

                        preparation area.  

                        Mope’ handles should be of metal or plastic

BROOMS         Nylon brooms are used in non-manufacturing

                        area. Wet swabbing follows sweeping with a broom.


DISINFECTANT REQUIRED:

Phenol             5%

Dettol               10%

Isopropyl alcohol 70%

FUMIGATING AGENTS:

Formalin              37%

For sterile area sterile disinfectants or fumigation agents are used.

CHANGE ROOM AND BUFFER ROOM:

1. Collect the dust settled over the fixtures & walls by using lint free cloth.

2. Sweep the floor thoroughly.

3. Use the wet mop for cleaning the floor.

STERILITY TESTING AREA:

1. Clean the workbench of laminar airflow using sterile mop soaked in efficient disinfectant. 

2. Clean the floor area with dettol by scrubbing with sponge kept separate for this purpose.

3. Now spray the room including laminar with the same disinfectant as used for moping walls and ceilings.

PROCEDURE FOR DRAINAGE:

Flow plenty of water in each drain and then put 5% phenol in drains, daily.

     FREQUENCY: Daily (Specially before sterility)