The document outlines the sterile gowning procedure for entering a filling area at Himo Pharmaceuticals. It details the step-by-step process for changing clothes, applying sterile shoe covers, and ensuring cleanliness before entering the filling room, as well as the de-gowning process afterwards. Key points include the importance of avoiding contamination and following proper protocols at each stage.

1. Entry Procedure For Sterile Filling Area
PRESENTED BY
USMAN SAEED
PROD. PH ARMACI ST
HIMO NT PH ARMACEUTICALS LAH ORE

2. GOWNING PROCEDURE
A) CHANGE ROOM-I FIRST GOWNING
(Kurta, Pajama and Hood)
B) CHANGE ROOM-II SECOND GOWNING
(Jump Suite, Cotton Mask and Gloves)
C) FILLING ROOM

3. A) CHANGE ROOM-I FIRST
GOWNING (Kurta, Pajama and Hood)
Take off shoes and place in the rack provided in the corridor outside the change room door.
Enter the change room.
Wear off all clothes except under garments and hang.
Cross over red line and get a pair of sterile shoe covers from the rack.
Disinfect the hands with suitable disinfectant provided according to the disinfectant rotation
plan.
Take Dress-I from the rack and wear cotton hood. Draw and wear cotton pajama and then
cotton Kurta
Wear a pair of gloves first on the left hand, then on the right and mop with the disinfectant
provided.
Open the door with elbow and enter the Change Room II.

4. B) CHANGE ROOM-II SECOND GOWNING (Jump Suite,
Cotton Mask and Gloves)
Take dress-II form the rack and start wearing stepwise.
Wear jump suite taking all precautions by sliding inside without letting the jump
suit to touch the floor. Also take care not to touch the outer surfaces of the suite.
Sit on the bench and wear one parachute shoe cover. Take shoe covered leg over
the bench to the other side. Remember don’t put the covered foot on the floor
before the bench.
Then wear second shoe cover and cross over the bench and standup.
Mop the gloved hand with disinfectant.

5. C) FILLING ROOM
After proper gowning, as described, enter the filling room for
operation.
Take care not to touch the door with gloved hands; open the door
with the help of elbows.
Keep the gown and gloves clean and mop the gloves with disinfectant
from time to time to avoid any contamination to the product.
Avoid any contact with walls and floors.

6. D) DE-GOWNING PROCEDURE
After completion of job or when required to come out of the area, reach slowly to the Change
Room-I, cross red line and de-gown stepwise.
Remove the shoe covers and put them in the disposal bag.
Carefully step out of jump suite and put them in the disposal bag.
Remove head cover and mask.
Wear off Kurta and pajama.
Put all the uniform in the disposal bag.
After de-gowning, move out of the area taking out the disposal bag.
Wear the street clothes. In the end, wear shoes from outside rack

7. Conclusion
For each batch or whenever entry is required.

8. THANKS FOR PARTICIPATION