ENTRY AND EXIT PROCEDURE IN MICROBIOLOGY LAB
PURPOSE: To provide a procedure for Entry & Exit in Microbiology Lab.
SCOPE: This procedure is applicable for Entry & Exit in the Microbiology Lab.
REFERENCES: In–house
CROSS-REFERENCE DOCUMENTS
Preparation, Review, Approval, Issuance & Retrieval of Standard Operating Procedures (SOPs)
Document(S) and Data Control Procedure
Attachment/Annexures/Formats
Pictorial Display For Entry / Exit Procedure to Microbiology Lab.
List of Authorized Person
Pictorial Display For Entry / Exit Procedure to Sterility Room.
Pictorial Display For Entry / Exit Procedure to MLT/CT Room.
Entry & Exit Record
RESPONSIBILITY:
Quality control Department person (Microbiologist):To follow this procedure during Entry & Exit in the microbiology lab.
Head QC/Designee shall be responsible for To review new or revised SOP, To maintain the controlled copies of SOPs at required location
Head QA/Designee shall be responsible for: To approve new or revised SOP,To ensure implementation of system as per defined SOP
Plant Head shall be responsible for: To approve new or revised SOP, To ensure implementation of system as per defined SOP.
PROCEDURE:
SAFETY/PRECAUTION/EHS
Entry in Microbiology Lab is restricted except authorized person.
Person suffering with illness must not enter the testing areas.
While wearing dangri /dress/gown, it should not touch to the ground.
Do not try to open interlocked both side at a time.
Entry procedure for Microbiology Lab (Main Entry)
Only authorized persons shall enter in microbiology as per Attachment-II and other persons (i.e. visitors, auditors, inspector and other person, whoever are not trained) allowed with authorized person for guidance.
Enter the password to unlock the door and enter into the Airock-1 and Follow the display pictorial as per current version Attachment-I for entry & exit in microbiology lab.
Remove the woolen cloths/Jackets (Additional street clothes worn during winters) and keep/hang it in the SS Rack.
Sanitize the hand with filtered 70% IPA provided in the Airlock-I and remove the street footwear and place it in the SS cross over bench provided in airlock –I and for visitor take shoes cover from box Provided in Airlock-I and wear it properly.
Now sit on the cross over bench and swing over to other side.
Take footwear for Air Lock-II from the Cross over Bench.
Sanitize the hand with filtered 70% IPA provided in the Airlock-I.
Press interlocking button to open the airlock door & enter to the Airlock-II.
Remove the footwear and place it inside the SS cross over bench provided in air lock-II or If wear the shoe cover than wear second pair of shoe cover on same street footwear with shoe cover from the box again.
Wear the Microbiology Laboratory Apron/Disposal apron provided in SS rack, mask and Cap/disposal cap from the Box provided on the cross over bench.
Sit on the cross over bench and swing over to other side.
Take Micro-Lab footwear from the Cross over Bench rack available in another side.
Examine yourself in the mirror provided in Airlock-II for proper and complete gowning.
Press interlocking button to open the airlock door & enter to the Incubator Room.
Exit procedure for Microbiology Lab (Main Entry)
To exit from the incubator room, press unlock button provided near the door to unlock the door and enter to the Airlock-II from incubator room.
Remove your Micro-lab footwear and place it in the Cross over Bench.
Sit on the Cross over Bench (COB) and swing over to other side
Remove the Cap and keep it in the pocket of apron. Now remove the apron keep it properly hanged in the SS Rack.
Note: If Disposal cap/apron than remove the cap & discard in bin as labelled ‘Used Cap/Apron’. If wear the second pair of shoe cover than remove the second pair shoe cover & discard in waste bin.
Take footwear for Air Lock-I from the Cross over Bench provided in air lock-II.
Push the unlocking door button provided near door and enter to the Airlock-I.
Remove the footwear and place it in the SS cross over bench
Sit on the cross over bench and swing over to other side.
If wear the first pair shoe cover than remove the first pair of shoe cover & discard in waste bin.
Wear your street shoes and other garments (if applicable).
Sanitize the hand with filtered 70% IPA provided in the Airlock-I.
Push the unlocking door button provided near door and exit to outer corridor from the Airlock-I.
Entry procedure for Sterility Room
Only authorized persons is allowed to enter in Sterility area list provided on the SOP stand.
To reach the sterility room person need to enter into the ‘Sterility/MLT entry corridor’ from incubator room.
By Pull out the door and enter into the ‘Sterility/MLT entry corridor’ from incubator room.
Biometric access is given to only those who are qualified and gone through the personal gown qualification plan.
Give your finger impressions on Biometric access machine and the door will unlock automatically and enter in to the Airlock-1 (Sterility area). Incase Biometric access is not working record the entry & exit in Attachment-V.
Remove your Cap/Mask/Shoe cover and apron and placed in to the SS rack provided in air lock-I. Remove your Microbiology lab footwear and keep it placed into the cupboard labeled as ‘Micro-lab Footwear’ provided in ‘Sterility Entry Airlock-I’.
Sanitize the hand up to the elbow with Filtered 70% IPA provided in Airlock-I (Sterility area).
Unlock the door by pushing the button provided near door and enter to the Airlock-II (Sterility Area).
Take out a set of sterilized primary gown from the cupboard provided in air lock-II and wear it, sequentially.
Enter in to Airlock-III, by pressing the interlocking button & opening the door and enter to the Airlock-III (Sterility Area).
Sanitize the hand with Filtered 70% IPA provided in Airlock-III (Sterility Area).
Take a sterile Gloves from the Dynamic Garment cubicle and wear it properly.
Sanitize the gloved hands with filtered 70% IPA provided in Airlock-III (Sterility Area).
Take a nose mask from the Garment cubicle and wear it properly.
Take a packet of sterilized garments/dress (dangri, booties) from the dynamic garment cubicle.
Ensure that any part of Sterile Garment except booties shall not be in contact with floor as well as wall.
Wear the dangri properly (Headgear is attached with dangri so carefully wear both).
Wear booties over the dangri.
Examine yourself into the mirror provided in Airlock-III (Sterility Area) for completeness and proper gowning.
Sanitize the gloved hands with filtered 70% IPA provided in Airlock-III (Sterility Area).
Sit on the cross over bench and swing over to other side.
Now Enter in to Airlock-IV (Sterility Area), by pressing the interlocking button & opening the door with the help of elbow and enter to the Airlock-IV (Sterility Area).
Take second set of elbow length sterilized gloves (if required) and wear it by taking the sleeves of dangri into the gloves.
Sanitize the gloved hands with filtered 70% IPA provided in Airlock-4 (Sterility Area).
Enter to the Sterility room corridor by pressing the interlocking button & opening the door with the help of elbow and enter in sterility room corridor.
Now person can move to sterility room or cooling zone area accordingly by pushing the respective door by elbow.
Exit Procedure from Sterility Room
To exit from the Sterility Room or Cooling zone area, enter in to the Sterility Corridor.
Push the unlock button provided near the door and enter to the Airlock-V (Sterility Area).
Remove the gloves, secondary gown (Dangri), mask, booties followed by primary gown and kept in a bin labeled as ‘Used Garment Bin’.
Unlock the door by pushing the interlocking button provided near door and enter to the Airlock-I Sterility Area.
Wear street cloths than wear the apron, cap, mask and footwear from the cupboard ‘Cupboard for garments’ and wear it properly.
Sanitize the hands with filtered 70% IPA provided in Airlock-I than push the unlock button provided near the door and enter to the ‘Sterility/MLT entry Corridor”
Enter to the incubator room from the ‘Sterility/MLT entry Corridor” by pulling the door.
To exit from the incubator room, follow the clause no. : 6.3.1 to 6.3.12.
Entry Procedure for MLT Room, Culture Testing Room and Disinfectant Preparation Room:
Only authorized personnel allowed to enter in MLT Room, Culture Testing Room and Disinfectant Preparation Room as per current version Attachment-IV.
To reach the MLT Room, Culture Testing Room and Disinfectant Preparation Room person shall enter into the ‘Sterility/MLT entry corridor’ from incubator room
Follow the Clause for enter to the Sterility/MLT entry corridor’.
Biometric access shall be provide to only those who are qualified and gone through the personal gown qualification plan.
Go for finger impressions on Biometric access machine and the door will unlock automatically and enter to the Airlock-I (MLT/CT Room). Incase Biometric access is not working record the entry & exit in current version Attachment-I.
Remove Cap/Mask/Shoe cover and drop in to the SS bin as labeled ‘Used Cap/Mask/Shoe cover’ and remove your Microbiology lab footwear and keep it placed into the cupboard labeled as ‘Micro-lab Footwear’ provided in Airlock-1 and take Footwear for Airlock-II from the cupboard (MLT/CT Room).
Remove the apron and keep it in the cupboard labeled as ‘Cupboard for Garments’ provided in Airlock-I.
Sanitize the hands with filtered 70% IPA provided in Airlock-I (MLT/CT Area).
Enter in to the Airlock-II, by pressing the interlocking button and open the door and enter to the Airlock-II (MLT/CT Room).
Remove your footwear and place it on the space provided in Cross over Bench
Now sit on the cross over bench and swing over to other side.
Take a sterile Gloves, gown (Dangri), booties and mask from the cupboard provided in air lock-II and wear it properly.
Ensure that any part of Sterile Garment except booties shall not be in contact with floor as well as wall.
Wear the dangri properly (Headgear is attached with dangri so carefully wear both).
Wear booties over the dangri.
Examine yourself into the mirror for complete and proper gowning.
Sanitize the hands with filtered 70% IPA provided in Airlock-II (MLT/CT Room) and by pressing the interlocking button & pushing the door with elbow to enter the ‘MLT/CT corridor’.
Enter in to the CT room, MLT room and disinfectant preparation room as required, by pushing the respective door with elbow from ‘MLT/CT corridor’.
Exit Procedure MLT Room, Culture Testing Room and Disinfectant Preparation Room.
To Exit from the MLT room, CT room or disinfectant preparation room, firstly move to ‘MLT/CT corridor’.
Enter to the Airlock-II (MLT/CT room) by pressing the interlocking button & opening the door with the help of elbow and enter to the Airlock-2 (MLT/CT Room).
Remove your gloves, mask and dangri and drop these into the bin labeled as ‘Used Garment Bin” & “Used gloves & Mask”.
Now sit on the cross over bench and swing over to other side.
Sanitize the hands with filtered 70% IPA provided in Airlock-II (MLT/CT Area).
Enter to Airlock-I (MLT/CT area) by pressing the interlocking button & opening the door with the help of elbow and enter to the Airlock-I.
Take apron, cap, mask and footwear from the cupboard ‘Cupboard for Micro-lab garments’ and wear it properly.
Sanitize the hands with filtered 70% IPA provided in Airlock-I (MLT/CT Area).
Enter to ‘Sterility/MLT entry Corridor’ by pressing the interlocking button & opening the door and enter to the ‘Sterility/MLT entry Corridor’.
Now enter to the incubator room from the ‘Sterility/MLT entry Corridor” by pulling the door.
To exit from the incubator room, follow the clause no.: 6.3.1 to 6.3.12.
Colour Coding For Garments and Footwear
Following colour coding and identification marks are provided on the micro-lab garments and footwear.
| SNo. | Microbiology lab Apron/cap (non-disposable) | For non-classified Area | White |
| 1 | Microbiology lab Apron/cap for Lab Boy | For non-classified Area | Grey |
| 2 | Microbiology lab Apron for visitors | For non-classified Area | Blue/White (Disposal) |
| 3 | Primary Gown for Sterility | For classified Area | White |
| 4 | Dangri for Sterility | For classified Area | Blue |
| 5 | Dangri for MLT, Culture Testing, and Disinfectant Preparation Room | For classified Area | Blue |
| 6 | Footwear for Microbiology Lab | For non-classified Area | White |
| 7 | Footwear for Airlock to Airlock | For Classified/non-classified Area | Black |
