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