Entry and exit of aseptic area

Table of Contents

1.0 OBJECTIVE: 

1.1 To lay down the procedure for the Entry and exit of aseptic area

2.0 RESPONSIBILITY:

2.1 All authorized personnel entering into aseptic area of parenteral section

2.2 Executive Aseptic area shall ensure that the procedure is being followed is in compliance with the SOP.

3.0 ACCOUNTABILITY:

3.1 Head-Production

4.0 PROCEDURE:

4.1. Entry procedure

4.1.1.Remove the secondary footwear and keep them in provided rack.

4.1.2.Push the door and enter first change room.

4.1.3.Remove the garments and keep them in provided rack.

4.1.4.Disinfect your hands using disinfectant solution provided.

4.1.5.Collect the primary garment from the rack (full suite, cap and booties).

4.1.6.Wear the cap and ensure hair is covered.

4.1.7.Wear trouser. Ensure the full suite should not touch the floor while wearing.

4.1.8.Wear the booties.

4.1.9.Disinfect the hands using disinfectant solution provided.

4.1.10.Cross the cross over bench.

4.2.Entry into the second change room.

4.2.1.Open the door by using elbow and enter into second change room. 

4.2.2.Pick one pair of pre sterilized primary gloves.

4.2.3.Open the cover of hand gloves and wear the hand gloves without touching the outer surface of gloves.

4.2.4.Open the garment cubicle door and collect tyvek bag containing one set of sterilized secondary garment. 

4.2.5.Close the garment cubicle.

4.2.6.Keep the tyvek bag containing secondary garment on cross over bench.

4.2.7.Disinfect the gloved hands using disinfectant solution provided.

4.2.8.Open the tyvek bag and wear headgear with out touching the outer surface.

4.2.9.Take the sterile suit and wear without touching the floor and outer surface.

4.2.10.Sit on the cross over bench and wear one booty to leg and ensure the lower portion of garment is tucked into the booty.

4.2.11.Tie the booty using strings.

4.2.12.Collect foot wear from stand and Keep the leg with booty on other side of the cross over bench and wear suitable foot wear

4.2.13.Wear the booty to second leg and ensure the lower portion of garment is tucked into the booty.

4.2.14.Tie the booty using strings.

4.2.15.Keep the leg with booty on other side of the cross over bench and wear remaining foot wear 

4.2.16.Transfer the empty tyvek bag along with gloves cover to waste bin.

4.2.17.Stand in front of the mirror and ensure the completeness of the wear.

4.2.18.Collect goggles and wear. 

4.3. Entry into the third change room.

4.3.1.Open the  door by using elbow and enter into  third change room.

4.3.2.Disinfect your hands using disinfectant solution provided.

4.3.3.Wear secondary hand gloves over the primary gloves and ensure the gloves should overlap the sleeves.

4.4.Entry into sterile corridor.

4.4.1.Push the  door with elbow and enter into the sterile corridor.

4.5.Personnel entering into filling area.

4.5.1.Push the door with elbow and enter into the filling area.

4.5.2.Disinfect your hands using disinfectant solution provided.

4.6.After completion of work in respective areas come back to the sterile corridor.

4.7.Exit Procedure:

4.7.1.Pull the door and enter into the fourth  change room.

4.7.2.Remove the foot wear and place them in rack.

4.7.3.Remove secondary gloves and transfer the used gloves to used gloves tray

4.7.4.Remove the goggles and Transfer the goggles to used goggles tray

4.7.5.Remove the booties and transfer them in bin.

4.7.6.Remove the sterile suit and head gear and transfer them to the bin.

4.7.7.Pull the door and enter into the first change room.

4.7.8.Remove the primary gloves and transfer to waste bin.

4.7.9.Remove the primary garments (booties, full suite along with the cap) and transfer them to used garments bin.

4.7.10.Open the rack, collect and wear primary wear.

4.7.11.Collect and wear the secondary footwear.

4.7.12.Exit from the first change room and proceed towards corridor

5.0 PRECAUTIONS TO BE TAKEN IN GOWNING AND FILLING ROOM

5.1 Do not talk

5.2 Do not touch any surfaces wtih hands, touch or handle only what is necessary.

5.3 Do not make unwanted movements

5.4 Do not make rapid movements

5.5 Do not look at the UV lights with naked eyes

6.0 REFERENCES:

6.1 Drugs and cosmetics act 1940   

6.2 SOP guidelines D.H.SHAH

7.0 ABBREVIATIONS:

7.1 CCRNO: change control reference number

7.2 SOP: standard operating procedure.                                                                                   

8.0 ANNEXURES

NIL