| Entry and Exit in Microbiology Testing Area |
| 1.0 OBJECTIVE To lay down the Procedure for the Entry and Exit in Microbiology Testing Area. 2.0 SCOPE This procedure is applicable for the Entry and Exit Procedure in Microbiology Testing Area Laboratory 3.0 RESPONSIBILITY • Laboratory attendant/ Microbiologist : is responsible for follow Sop. • Manager microbiology : is responsible for ensuring that the SOP is followed correctly 4.0 ACCOUNTABILITY • Department Head 5.0 PROCEDURE 5.1 Microbiology general area 5.1.1 Microbiology Testing Area includes Air lock I, II and III, Sterile Corridor, Cool zone, LAF rooms, return Air Lock- I and II. 5.2 Requirements 5.2.1 Sterile garment, surgical gloves 5.2.2 Mask 5.2.3 70% IPA 5.2.4 Goggles To read this SOP click here SOP for Operation Of Colony Counter. 5.3 Safety and Precaution 5.3.1 If person suffering from any injury and disease should not allowed to enter into microbiology lab. 5.3.2 All Personnel entering into the testing area shall be qualified on the procedure prior to the entry. 5.3.3 Ensure that both the doors of change rooms are not open at a time. 5.3.4 Do not touch any wall and other surface. 5.3.5 Do not make rapid movements. 5.3.6 Visitor/auditor shall be accompanied with authorized person. 5.4 Entry Procedure in Sterility Testing Area. 5.4.1 Personnel shall be entering as per current SOP “Entry and Exit procedure of Microbiology Lab” SOP No. XXX. 5.4.2 Check observe the DP of the Magnehelic gauge of MLT area if it is not within the specified limit inform to engineering and do not enter into the area for testing purpose. 5.4.3 Make the entry details into the format No. XXX. Entry/exit in testing area. 5.4.4 Wear face mask before entry in Sterility Testing Area. 5.4.5 Push the door with the help of elbow and enter in change Room-I. 5.4.6 Remove the apron, cap and street garments (except under garment) and remove the lab slippers and keep in SS garment cabinet. 5.4.7 Sanitize the hands up to the elbow with 70%IPA in change Room-I. 5.4.8 Push the door elbow and enter in air Lock-I. 5.4.9 Take out a fresh set of primary garment (Which comprises of headgear, jacket, trouser and booties) from the primary garment box. 5.4.10 Wear primary headgear followed by jacket, trouser and booties. 5.4.11 Push the door with help of elbow and enter in Air lock-II. 5.4.12 Sanitize the hands with 70% IPA. That provided in the dispenser. 5.4.13 Switch OFF the UV light of dynamic garment cabinet and open the door of dynamic garment cabinet. 5.4.14 Take one set of sterile gloves from sterile garment cabinet and wear. 5.4.15 Take one set of sterile garment containing headgear, boiler suit and booties. 5.4.16 If wrapped in butter paper/bacteriological paper remove it is wrapping and keep the removed wrapping paper into the SS waste bin. 5.4.17 Put on first sterile head gear, boiler suit and booties without touching floor respectively. 5.4.18 Close the boiler suit from bottom to top with the help of the zipper. 5.4.19 Tie the boiler suit over the belly with the help of the string provided in the inner portion of the garment. 5.4.20 Ensure during wearing sterile garment that any part of sterile garment is not to touch the any surface (wall, floor) etc. 5.4.21 Wear disinfected/sterile goggles. 5.4.22 Sanitize the hands with 70% IPA and wear a second pair of glove. 5.4.23 Wear dedicated aseptic area slipper. 5.4.24 Open the door by pushing the door with the help of elbow and enter into the air-lock-III. 5.4.25 Check over self out fit in the mirror and wait for one minute into air-lock-III for relaxing. 5.4.26 Then open the door by pushing the door with the help of elbow and enter in sterile corridor of sterility testing area. 5.4.27 Now enter into different rooms of the sterility testing Room-I, sterility testing-II and autoclave unloading area as per requirement by pushing the door with the help of elbow. 5.5 Exit Procedure in Sterility Testing Area. 5.5.1 After completion of work/visit pull the sterility Room door and comes in sterile corridor. 5.5.2 Now pull the exit door and enter in return Air lock-II and enter in return Air Lock-I. 5.5.3 Personnel shall remove in the following sequence • Booties • Boiler suit • Head cover • Hand gloves 5.5.4 The used garment shall be put in the used SS garment bin in return change Room-I for washing and subsequent sterilization. 5.5.5 Personal shall be wear the street garments, lab apron, cap, mask and footwear in change Room-I and pull the door and comes into Microbiology General Area corridor. 5.6 Entry Procedure in Microbial Limit Test/Bio-Safety Area. 5.6.1 Perform steps 5.4.1 to 5.4.26 for enter in Microbial limit testing. 5.6.2 From there enter into different rooms of the Microbial Limit testing and Bio-Safety change room and Bio-Safety room as per requirement. 5.7 Exit Procedure in Microbial Limit Test/Sub-Culturing Area. 5.7.1 After completion of work/visit pull the MLT room/sub-culturing room door and comes in sterile corridor. 5.7.2 Perform steps 5.5.2 to 5.5.5 for exit in MLT/ Bio-Safety Area. 5.8 Entry Procedure in BET Room 5.8.1 Visually observe the pressure differential reading on the magnehelic gauge before entering into the BET room. It should be in the specified limit if pressure differential is not within the limit inform to the engineering to rectify the pressure differential problem and do enter into the area for testing purpose. 5.8.2 Open the door of personnel entry BET room by pushing the door and enter into the airlock. 5.8.3 Wear sleepers, mask and gloves in BET change room. 5.8.4 Open the door of the BET room by pushing the door and enter into the room and sanitize the hands with 70% IPA. 5.9 Exit procedure in BET Room 5.9.1 After completion of the work come into the personnel entry air lock by pulling the door. 5.9.2 Put off the gloves and put into SS waste bin, remove sleeper. 5.9.3 Open the door of air lock by pulling the door handle come into outside corridor. 5.9.4 Record the exit details in format No. XXX. |
