Gowning room Entry Procedure

1.0 OBJECTIVE
To lay down a procedure before the personnel entering into:
A) Pharma manufacturing modules.
B) Dispensing rooms.
C) Primary packing machine rooms.
D) Raw material sampling room.
2.0 SCOPE
2.1.1 Applicable to all persons who are entering in to the above mentioned areas.
3.0 RESPONSIBILITY
Concerned persons.
4.0 ACCOUNTABILITY
Workmen(T) /Production associates/Technical associates/ Jr. Technical officers-Production officer
Officers-Executive
Executive and above-Plant Manager
5.0 PROCEDURE
5.1.0 Precautions.
5.2.0 Entry procedure.
5.1.0 Precautions
5.1.1 The person allotted to one module or work place should not enter into the other Modules or work place without proper reason or until and unless authorized by the concerned department heads.
5.1.2 Every alternative day / product changeover or whenever necessary the boiler suit should be changed.
5.2.0 Entry procedure
5.2.1 Enter respective gowning rooms through external corridors (through personnel entry only).
5.2.2 Remove the factory slippers.
5.2.3 Keep them in the slipper rack.
5.2.4 Cross the step over bench gently by sitting on it.
5.2.5 Collect the boiler suit from hanger.
5.2.6 Put on the boiler suit
5.2.7 Put on clean booties and tie them properly over the boiler suit.
5.2.8 Put on the headgear and tie it properly.
5.2.9 Wash your hands with the disinfectant.
5.2.10 Collect the gloves from SS box.
5.2.11 Ensure that personnel entry door is closed and open the door which takes you into the module.
5.2.12 Put on the gloves in the process corridor (before entering into respective rooms).