SOP for Entry and Exit Procedure in Microbiology Lab

By / Microbiology / Microbiology, SOP /

SOP for Entry and Exit Procedure in Microbiology lab in Pharmaceutical Industry

  • SOP covers below points :
    • Safety And Precautions
    • Entry and Exit procedure for Microbiology Section area
    • Exit procedure for QC Staff and Microbiologist from Microbiology Section
    • Entry procedure for QC Staff and Workers to MLT area
    • Exit procedure for QC Staff and Worker from MLT area
    • Entry procedure for QC Staff and Workers to Sterility room
    • Exit procedure for QC Staff and Workers from Sterility room
    • Entry procedure for QC Staff and Workers into culture handling room
    • Exit procedure for QC Staff and Workers from culture handling room
    • Entry procedure for Visitors in microbiology section
    • Exit procedure for Visitors in microbiology section
    • Usage Log For Entry And Exit Record For Sterility Area
    • Usage Log For Entry And Exit Record For Microbiology Area
1.0 OBJECTIVE :
  • To lay down a procedure for the entry and exit procedure into Quality Control Department of Microbiology area.
2.0 SCOPE :
  • This SOP is applicable for the entry and exit procedure into Quality Control Department of Microbiology area.
3.0 RESPONSIBILITY :
  • The QC Staff shall be responsible for:
    • Following the entry and exit procedure.
    • Monitoring the entry and exit procedure.
  • The other departmental heads will be responsible to:
    • Train the subordinates of respective department to follow the SOP.
  • The Manager-QC shall be responsible for:
    • Ensuring compliance of the SOP
4.0 ACCOUNTABILITY:
  • Quality Control Head

SAFETY AND PRECAUTIONS:

  • Follow strictly the below entry procedure without contaminating the uniforms meant for others.
  • Carry tools required only after effective sanitation.
  • Carry out the major work in aseptic area when no activity is being performed.
  • Do not touch the doors; partitions etc. after your hands are disinfected with antiseptics and after putting on sterile hand gloves. Do not pick up any material fallen on the floor.
  • Any worker/staff suffering from the contagious disease like skin infection, cold, fever and open wound inform to the department head, for assigning the different job. 
5.0 PROCEDURE :

5.1 Entry and Exit procedure for Microbiology Section area:

  • Keep the finger on “Finger Print Controller” till beep sound.
  • Push the door of QC corridor entrance and enter into the corridor of Quality Control Department.
  • Remove the slipper and keep in SS cupboard and then sit on the cross over bench and pass.
  • Wear the company provided shoes which is provided in the rack of cross over bench.
  • Enter into microbiology section by pushing the door.
  • Open the door of the SS cupboard and wear the apron and cap.
  • Remove the company provided shoes in SS cupboard and keep in the rack of the cross over bench.
  • Sit on the cross over bench.
  • Lean over the cross over bench and pick up shoes from inside of cross over bench and keep shoes inside the microbiology lab area.
  • Wear the shoes without touching the floor on the microbiology lab area and stand up.
  • Check the dress well-worn in the mirror.
  • Disinfect the hands with filtered 70% v/v IPA solution and enter into microbiology lab.
  • Enter into respective areas such as media preparation room, autoclave room and incubation room as per the requirement.
  • QC staff, those responsible to work in Microbiology section, shall follow the defined procedure for entering into MLT area, Sterility room and culture handling room.

5.2 Exit procedure for QC Staff and Microbiologist from Microbiology Section:

  • Sit on the Cross over Bench, remove the shoes and cross the crossover bench.
  • Lean over the bench and pick up shoes, keep inside the cupboard.
  • Disinfect the hands with filtered 70% IPA solution.
  • Wear the company provided shoes.
  • Remove the apron and cap and put in the SS bin provided in Change Room-I.
  • Pull the door and exit from Microbiology section.

5.3 Entry procedure for QC Staff and Workers to MLT area:

  • Press the interlocking button, and green signal glows on the door.
  • Then push the door and enter in change room I.
  • Disinfect the hands with filtered 70% v/v IPA solution.
  • Remove the shoes and cap.
  • Wear the sterile gloves and remove the cleaned over gown from the cupboard, then wear the headgear.
  • Wear the slipper.
  • Disinfect the hands with filtered 70% v/v IPA solution.
  • Press interlocking button and green signal glows on door.
  • Then push the door using elbow and enter in MLT room.

5.4 Exit procedure for QC Staff and Worker from MLT area:

  • Press interlocking button in MLT area and green signal glows on the door.
  • Then pull the door and enter in change room I.
  • Remove the slipper, gown/suit, and head gear and put in the bin.
  • Disinfect the hands with filtered 70% v/v IPA solution.
  • Press interlocking button in change room I, green signal glows on the door.
  • Then pull the door and exit from the change room-I.

5.5 Entry procedure for QC Staff and Workers to Sterility room:

  • Press interlocking button, green signal glows on the door.
  • Then push the door and enter in change room I.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Remove the lab apron and personal wearing clothes and company provided shoes in the rack.
  • Spray the 70% v/v IPA solution in right and left legs and then put the legs on the lint free cloths.
  • Disinfect the hand up to elbow by using filtered 70% v/v IPA solution.
  • Press interlocking button, green signal glows on door, then push the door using elbow and enter into change room II.
  • Wear the sterile gloves provided in the sterile gloves bin.
  • Open the sterile sleeves, wear the shirt with headgear first, followed by Pant and then last booties. (Tuck the shirt into pant and pant into booties).
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Wear the sterilized uniform over the sleeves (single suit with booties attached) in such a manner that lower end flaps of headgear are tucked under the neck of the sterilized uniform. (Do not touch the sterilized uniform to floor).
  • Close the ZIP of the sterilized uniform.
  • Wear the sanitized slippers. Wear the safety goggles properly put on the sterile booties.
  • Stand in front of the mirror provided and ensure that no any body part is exposed.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Press interlocking button, green signal glows on door, then push the door using elbow and enter into air lock.
  • Wear the second sterile hand gloves over the gloves for protection.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Press interlocking button, green signal glows on door, then push the door using elbow and enter into sterility room.

5.6 Exit procedure for QC Staff and Workers from Sterility room:

  • Push the interlock button and green signal glows on the door. Pull the door of sterility room and enter into the air lock.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Push the interlock button and green signal glows on the door. Pull the door of sterility room and enter into the change room II.
  • Remove the slipper and keep into the SS bin for sanitizing overnight.
  • Remove the uniform, headgears, hand gloves and sleeves and keep in SS bin for disposal and cleaning.
  • Spray 4-6% sodium hypochlorite solution on the used sleeves and uniform when sterility testing done of anticancer products only and put them in the SS bin provided for cleaning purpose.
  • Remove the surgical hand gloves and deactivate with 4-6% sodium hypochlorite solution when sterility testing done of anticancer products only and send the hand gloves to scrap yard.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Push the interlock button and green signal glows on the door. Pull the door of change room II and enter into the change room I.
  • Wear the personal wearing clothes and then wear lab apron and company provided shoes.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Push the interlock button and green signal glows on the door. Pull the door of change room I and enter into the micro area corridor.

5.7 Entry procedure for QC Staff and Workers into culture handling room:

  • Press the door and enter into the change room of culture handling room.
  • Disinfect your hand with filtered 70% v/v IPA solution.
  • Wear the shoe cover over the company provided shoes.
  • Then wear full gown apron over the lab apron, then wear cap and nose mask which is provided in the cupboard.
  • Wear the sterile hand gloves.
  • Disinfect your hand gloves with filtered 70% v/v IPA solution.
  • Push the door by using the elbow and enter into the culture handling room.

5.8 Exit procedure for QC Staff and Workers from culture handling room:

  • Pull the door and enter into the change room.
  • Disinfect your hand gloves with filtered 70% v/v IPA solution.
  • Discard the hand gloves into the dustbin provided.
  • Remove the nose mask, full gown apron and cap and keep it in bin provided.
  • Remove the shoe cover and keep it in waste bin provided.
  • Pull the door and enter into the microbiology area corridor.

5.9 Entry procedure for Visitors in microbiology section:

  • Head-QC will keep the finger on “Finger Print Controller” till beep sound.
  • Push the door of QC corridor entrance and enter into the corridor of Quality Control Department.
  • Sit on the cross over bench, wear the shoes cover and cross the bench.
  • Enter into microbiology section by pushing the door
  • Wear apron with head cap which is provided in SS cup board.
  • Sit on the cross over bench and wear another set of shoes cover.
  • Disinfect hand with filtered 70% v/v IPA solution.
  • Enter in to microbiology area.

5.10 Exit procedure for Visitors in microbiology section:

  • Sit on the cross over bench and cross the bench.
  • Remove the apron and head cap and keep in SS cupboard.
  • Remove upper pair of shoe covers and put them in SS bin.
  • Push the door and exit from microbiology section.
  • Sit on the cross over bench main entry of quality control and cross the bench.
  • Remove shoe covers and put them in bin provided for keeping used shoe covers.
  • Press the push key of “Door Station” for door release. The green light of “released” will glow.
  • Pull the door of the QC corridor entrance and exit from QC corridor
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
QAQuality Assurance
QCQuality Control
SSStainless steel
IPAIsopropyl alcohol

7.0 ANNEXURES:
  Annex. No.Title
01Usage Log For Entry And Exit Record For Sterility Area
02Usage Log For Entry And Exit Record For Microbiology Area

8.0 SOP REFERENCES
  • In-House

END OF THE SOP

ANNEXURES :

Annex. No. 01 Usage Log For Entry And Exit Record For Sterility Area

Annex. No. 02 Usage Log For Entry And Exit Record For Microbiology Area