Entry and exit Procedure for sterility testing area

Table of Contents

1.0 OBJECTIVE:

To lay down the procedure for the Entry and exit of sterility testing area

2.0 SCOPE:

This procedure is applicable to provide guidelines to enter into Sterility testing area of Company Name

3.0 RESPONSIBILITY:

3.1 Microbiologist /Officer is responsible for the execution. 

3.2 HOD or designee is accountable for review, effective implementation, and compliance with the entry and exit procedure.               

4.0 PROCEDURE:

4.1 Entry Procedure 

4.1.1 Push the door with the help of elbow to enter into the room.

4.1.2 Remove Lab footwear in the designated place. 

4.1.3 Remove the apron and keep them in the respective area. 

4.1.4 Entry into First Change Room

4.1.4.1 Disinfectant the hands with a disinfectant solution provided.

4.1.4.2 Wear sterilized hand gloves as shown in the figure

4.1.4.3 Open the garment cubicle door and collect sterile suite containing set of sterilized garments and Close the garment cubicle.

4.1.4.4 Wear sterile Suite as given in the diagrams

4.1.4.5 Keep the sterile suite bag containing secondary garment on the cross over  bench.

4.1.4.6 Disinfect the gloved hands using the disinfectant solution provided.

4.1.4.7 Open the sterile suite bag and wear a hood without touching the outer surface.

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

4.1.4.9 Sit on the cross over the bench and wear booty’s to the first leg and ensure that lower portion of the garment is tucked into the booty.

4.1.4.10 Tie the booty using strings.

4.1.4.11 Keep the leg with booty on another side of the cross over the bench.

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

4.1.4.13 Tie the booty using strings.

4.1.4.14 Wear the footwear provided.

4.1.4.15 Keep the leg with booty on another side of the cross over the bench.

4.1.4.16 Transfer the empty sterile suite bag along with gloves cover to waste bin

4.1.5 Entry into Second Change Room

4.1.5.1 Push the door with the help of elbow to enter into the second change room.

4.1.5.2 Remove the primary gloves and Wear working hand gloves ensure the gloves should overlap the sleeves.

4.1.5.3 Push the door and enter into the sterile corridor.

4.1.6 Entry into sterility testing room

4.1.6.1 Push the door with the help of elbow to enter into the sterile testing room.

4.1.6.2 Disinfect your hands using the disinfectant solution provided.

4.1.6.3 Complete the sterility testing as per SOP

4.2 Exit Procedure:

4.2.1 Push the door with the help of elbow to enter into the third change room.

4.2.2 Remove the footwear and place them in the designated place. 

4.2.3 Remove working gloves and transfer the used gloves to used gloves tray

4.2.4 Remove the booties and transfer them in the bin.

4.2.5 Remove the sterile suit and headgear and transfer them to the bin.

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

4.2.7 Open the rack, collect and wear primary wear.

4.2.8 Collect and wear the primary footwear.

4.2.9 Exit from the first change room and proceed towards the corridor

5.0 ABBREVIATIONS: 

Nil

6.0 ANNEXURES

Nil