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Saturday, May 8, 2010

STANDARD OPERATING PROCEDURE Title: Change Procedure for Sterile Area

1. Purpose
1.1 It is established to provide a standard procedure for “sterile gowning” for working in sterile filling areas.
1.2 It is established to avoid sterile area contamination due to personnel body shedding.
2 Scope
2.1 It is applicable to Sterile Areas.
3 References
3.1 Clean Room Regulations (GL/SOP/015)
4 Responsibilities
4.1 Production Pharmacist
4.2 Supervisor
4.3 Worker
5 Procedure
5.1 Necessary Instructions
5.1.1 Get inspected by the supervisor/pharmacist before going to the sterile areas so that personnel hygiene certificate may be issued for the personnel working in sterile area.
5.1.2 Always wear a sterile uniform in sterile buffers only.
5.1.3 Always take uniform from the well closed Autoclave box kept in sterile buffer II.
5.1.4 Be sure that uniform is sterile by noting the color of autoclave tape on the uniform wrapper; color of autoclave tape should be brown.
5.1.5 Don’t wear a uniform with torn wrapper.
5.1.6 Don’t wear a torn or soiled uniform.
5.1.7 Always keep the uniform laces (neck, wrist, waist, foot and knee etc) tight.
5.1.8 No body parts/under garments should be exposed from beneath of uniform.
5.1.9 Don’t take off any item from beneath of uniform.

5.2 Change Steps
5.2.1 Put off factory uniform in sterile buffer-I; uniform may be put on over the factory uniform provided it is neat & clean.
5.2.2 Enter sterile buffer-II.
5.2.3 Open the autoclave box & wear sterile gloves kept at the top; spray disinfectant solution on the gloves with the help of disinfectant spray bottle.
5.2.4 Take sterile uniform properly wrapped in butter paper.
5.2.5 Unwrap sterile uniform & dispose off the butter paper & aluminum foil in the waste bin.
5.2.6 Wear head gear first & tight the laces behind the skull; only eyes with covered eye brows should be exposed.
5.2.7 Wear shirt over head gear in such away that head gear’s lower margin are inside the shirt; tie up neck laces & wrist laces of the shirt.
5.2.8 Wear the trousers in such a way that shirt’s lower margin are inside the trousers; tight the waist laces & ankle laces of the trousers.
5.2.9 Wear the autoclaved shoes; shoes may be skipped off.
5.2.10 Wear shoe cover over the trouser surface & tight the laces near the knee.
5.2.11 Wear off the gloves & dispose off in waste bin.
5.2.12 Spray the hands with disinfectant; wear sterile gloves in such a way that wrist laces of the shirt are under the gloves.
5.2.13 Be sure that no laces are loose or hanging from the uniform.
5.2.14 Spray the gloves with disinfectant.
5.2.15 Take a self view in mirror to correct any fault in wearing; uniform should give an active look.
5.2.16 Now enter the sterile area.
6 Quality Record
6.1 Personnel Hygiene Certificate

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