SOP on Entry Exit in MLT area

1.0 OBJECTIVE:

To lay down a procedure for entry and exit procedure for Sterility and MLT room in Microbiology Lab.

2.0 SCOPE:

This Standard operating Procedure is applicable for all authorized persons and workmen entering in Sterility and MLT room in Microbiology Lab at XXXX HEALTHCARE, XXX, XXXX.

3.0 RESPONSIBILITY:

All authorized persons entering in Microbiological Lab.

4.0 REFERENCE : Schedule –M

5.0 ACCOUNTABILITY:

Head Quality Control and Head Quality Assurance shall be accountable for ensuring the compliance to this procedure.

6.0 PROCEDURE:

6.1 General Precautions:

6.1.1 Quality control Microbiologist shall prepare a list of authorized persons to enter in the Sterility / MLT area from departments i.e. Quality control, Quality assurance, Engineering etc.

1.1.1 Microbiologist shall ensure, the person entering in Sterility/ MLT area is not suffering from any contagious disease, if found he/she shall not be allowed to enter in the area under any circumstances.

1.2 Entry Procedure:

1.2.1 Ensure for the name in Authorized person list.

1.2.2 Before entering ensure that air handling unit of the area is switched on.

1.2.3 Place all the testing accessories / sample in pass box before entering Air lock -1.

1.2.4 Ensure removal of ornaments and other personal belongings before entering into ‘Air lock -1’.

1.2.5 Remove laboratory slipper and keep them in SS rack provided outside Air lock -1.

1.2.6 Enter in Air lock -1, remove the laboratory coat and hang them on the hanger provided.

1.2.7 Dip the bare feet in trays containing disinfectant solution. Ensure that the disinfectant solution should touch the feet upto ankle.

1.2.8 Mope feets using lint free cloth provided without touching it with hands.

1.2.9 Enter into airlock -2 by pushing the door by elbow.

1.2.10 Disinfect both the hands with 70 % v/v isopropyl alcohol. Put on sterile gloves first & take a pack of sterilized garments from autoclaved surgical box kept in air lock -2.

1.2.11 Wear sterile hood overhead so as to properly cover hair and nose.

1.2.12 Wear sterile cover-all and booties taking care that sterile cover-all does not touch floor or walls and wear safety goggles.

1.2.13 Check yourself in front of mirror provided in second air lock for proper gowning.

1.2.14 Pull the sterile gloves to overlap the sleeves of sterile dress.

1.1.1 From Air lock-2 enter in MLT room by opening the door with elbow (when required in MLT Room)

1.1.2 From Air lock-2 enter in Air lock 3 and subsequently in Sterility room by opening the door with elbow (when required in Sterility Room).

1.1.3 Take out testing accessories / sample from pass box wipe them with 70% IPA and put them in LAF in such way that it does not obstruct the flow of LAF.

1.2 Exit Procedure:

1.2.1 After completion of work transfer all the media and equipment from the LAF to pass box.

1.2.2 Clean the LAF with approved disinfectant and switch OFF the LAF at the end of day activity.

1.2.3 For Sterility room, remove the sterile gown in Air lock IV and place it in used garment and gloves bin. Then enter in airlock-1.

1.2.4 For MLT room, Enter the airlock-1 from exit door of MLT room.

1.2.5 Wear laboratory coat and cap in airlock-1 and exit from airlock-1

1.2.6 Finally wear Primary sleepers from the racks provided.

1.0 ANNEXURE:

1.0 ABBREVIATION (S):

SOP - Standard Operating Procedure

QC - Quality Control

QA - Quality Assurance

MIC - Microbiological

LAF- Laminar air flow

MLT- Microbial Limit Test

2.0 HISTORY:

Revision No.

Reason 00

New SOP after merging two previous SOPs , SOP/QC/MIC/001, Entry and exit procedure for MET / Bioassay room and SOP/QC/MIC/002, Entry and exit procedure for sterility area

10.0 SAFETY CONSIDERATIONS:

NA