SOP for Entry and Exit into Microbiology Testing Area and Sterility Testing Area : Pharmaguideline

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SOP for Entry and Exit into Microbiology Testing Area and Sterility Testing Area

Standard operating procedure to enter and exit in the microbiology testing area and sterility testing area.

1.0 Purpose

To lay down the procedure for entry and exit in microbiology testing area and sterility testing area.

2.0 Scope

It is applicable to Microbiology lab

3.0 Responsibility

Microbiologist

4.0 Accountability

Head of Department

5.0 Procedure

5.1 Entry into the Microbiological testing area

5.1.1 Enter the room No.1 by pressing the ‘push’ button situated on the doorframe when green color light glows push the door.
5.1.2 Wear the shoe cover, cross the cross over bench and enter in room No. 2.
5.1.3 Sanitize the hand with hand disinfectant.
5.1.4 Wear the hood to cover the hairs completely, then wear a long apron and tuck the hood neatly inside the apron.
5.1.5 Wear the safety goggles and cross the cross over bench.
5.1.6 Wear the sterile gloves and disinfect the hands with hand disinfectant. Press the ‘push’ button situated in the doorframe, when green light glows push the door and enter room No. 7
5.1.7 After completion of work, come out of the testing area by pressing ‘push’ button and pull the door only when green light glows.
5.1.8 Cross the cross over bench, remove the gloves and put them in the waste bin, remove the goggles and put them in used goggles bin.
5.1.9 Enter the room No. 1 by crossing the cross over bench. Remove the long apron and hood and put them in used dress bin for washing.
5.1.10 Remove the shoe covers and put them in the waste bin.
5.1.11 Exit room No. 1 by pressing ‘push’ button and pull the door only when green light glows.

5.2 Entry into Sterility testing area.

5.2.1 Ensure that air-handling unit of sterility test area is switched on at least one hour before starting testing in sterility testing area.
5.2.2 Remove watch, finger ring and other ornaments, before entering sterility test area.
5.2.3 Enter the room No.1 and remove the lab apron, street cloth (except undergarments) and keep them into the shelf. Remove the shoes and place them beneath the shelf.
5.2.4 Wear the shoe cover and cross the cross over bench and enter in room No. 2.
5.2.5 Wear primary gowning as mentioned in point No. 5.1.4 instead of hood wear cap to cover the hairs and sterile gloves for sterility.
5.2.6 Enter into the room 3 by pressing ‘push’ button on the doorframe and push the door only when green light glows. Sanitize the hands with hand disinfectant.
5.2.7 Open the sterile dress cabinet and wear the hood by tying its laces behind the head and covering nose, mouth and all the hairs completely. Adjust the space provided for eyes for comfortable vision.
5.2.8 Wear the sterile gown taking care that sterile dress does not touch floor or walls. Tuck the hood neatly inside the gown. Pull the sterile gloves to overlap the sleeves of the sterile dress.
5.2.9 Wear sterile booties on both the feet and wear safety goggles.
5.2.10 Wear the second pair of sterile gloves over the first one and sanitize the hands with hand disinfectant.
5.2.11 Enter the room by pressing ‘push’ button on the doorframe and push the door only when green light glows, with the help of elbow.
5.2.12 Check in the mirror that gowning is proper.
5.2.13 Check whether the hood is properly covering hair, nose and other parts of the face and is tucked inside the sterile dress.
5.2.14 Check whether gloves are properly stretched over sleeves of the sterile dress
5.2.15 Check whether booties are properly tied over legs.
5.2.16 Enter the sterility area by opening the door using elbows.
5.2.17 Disinfect the hand with 70% Isopropyl alcohol / the disinfectant available on that day before starting sterility test.
5.2.18 For unloading the media from the autoclave and for taking the accessories and samples from the pass box enter the room No. 6 pushing the door with the help of elbow.
5.2.19 After completion of sterility test exit room No. 5 by pressing ‘push’ button on the doorframe and pull the door only when green light glows.
5.2.20 Exit the airlock room No. 4 by pressing ‘push’ button on the doorframe and pull the door only when green light glows.

5.2.21 Remove the gloves and put it into the waste bin. Remove the goggles and put them in used goggles bin in room no 3.
5.2.22 Remove the hood, gown and then booties and put them in used dress bin for washing in room No. 3.
5.2.23 Exit room No. 3 by pressing ‘push’ button and pull the door only when green light glows.
5.2.24 Cross the cross over bench in room No. 2 remove the primary gowning and put it into the used dress bin for washing. Remove the shoe cover and put it in the waste bin.
5.2.25 Wear the street clothes, cap, lab apron and exit room No. 1 by pressing ‘push’ button and pull the door only when green light glows.
5.2.26 Visitors are allowed inside the controlled area with the assistance of the trained and authorized personnel.
Related: SOP for Entry and Exit into Quality Control Laboratory

6.0 Abbreviations

6.1 SOP - Standard Operating Procedure
6.2 % - Percentage
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