1.0 Objective:
To lay down the procedure for Entry and exit procedure for Microbiology Laboratory.
2.0 Scope:
This SOP is applicable for Entry and exit procedure for Microbiology Laboratory in Quality Control Laboratory of pharmaceuticals formulation plant.
3.0 Responsibility:
Chemist or above of QC Laboratory.
Head – Microbiology Section.
4.0 Accountability:
Head – Quality Control.
5.0 Abbreviations:
- SOP : Standard operating procedure
- No. : Number
- QC : Quality Control
- QA : Quality Assurance
- COB : Cross Over Bench
- S : Stainless steel.
6.0 Procedure:
6.1 Microbiology laboratory-General Areas
6.1.1 Microbiology laboratory general areas include, Air Lock of main entry, General corridor, Microbiology office, Incubators room and Glass ware storage room.
6.1.2 Entry:
6.1.2.1 For Staff: Enter the Quality Control Department through the staircase.
6.1.2.2 Remove the street footwear and keep them in the designated place.
6.1.2.3 Cross over the COB (Cross over Bench) and wear dedicated QC slippers.
6.1.2.4 Open the Garment cubicle, Pick and wear dedicated white Apron.
6.1.2.5 Open the entry door and reach the Microbiology Section through QC corridor.
6.1.2.6 Press interlocking button to open the airlock door.
6.1.2.7 Open the entry door and enter into the Air lock of Microbiology Section. Remove the dedicated QC slippers and keep them in designated place.
6.1.2.8 Cross over the bench and wear the dedicated Microbiology lab slippers.
6.1.2.9 Press the interlocking button and open the door and enter into Microbiology Lab General Corridor.
6.1.2.10 From Microbiology Lab General corridor, enter into different areas as required, following the described entry procedure of respective area.
6.1.2.11 For Visitors: Use Full sleeve white visitor apron, cap, shoe cover instead of staff apron, Cap and dedicated QC and Microbiology slippers.
6.1.2.12 For Helpers: Use Dedicated Factory Dress (Pant, Shirt, Cap) instead of Staff dress, (Full sleeve white apron and cap) and the remaining entry procedure as same as staff.
6.1.2.13 Note: Wear Dedicated Factory Dress in the change room after removing the street garments.
6.1.3 Exit:
6.1.3.1 Press inter locking button to open the air lock door.
6.1.3.2 Open the exit door of main entry Air lock and enter in to the Air lock. Keep the dedicated Microbiology lab slippers in the designated place. In the case of shoe covers, remove the covers and put them in the dust bin.
6.1.3.3 Cross over the COB (Cross over Bench) and wear dedicated QC slippers.
6.1.3.4 Press the interlocking button and open the door leading to QC corridor.
6.1.3.5 Open the door leading to exit from the QC.
6.1.3.6 Remove apron and cap and hang them in the designated place of the Garment Cubicle. Place the dedicated QC slippers in the designated place. In the case of shoe covers, remove the covers and put them in the dust bin.
6.1.3.7 Cross over the COB (Cross over Bench) and wear street footwear.
6.1.3.8 Open the exit door and reach the staircase to depart from the QC Department.
6.1.3.9 In the case of Dedicated Factory Dress, remove the dress in the change room and wear the street garments.
6.2 Microbiology laboratory – Sterilization Areas:
6.2.1 Microbiology laboratory – Sterilization Areas include, Air Lock of Sterilization room, Sterilization room, washing area, Decontamination room and Media preparation room.
6.2.2 Entry:
6.2.2.1 Open the Air lock entry door of sterilization room and enter into the Air lock.
6.2.2.2 Wear face mask.
6.2.2.3 From Air lock enter in to different rooms of the sterilization area as per requirement.
6.2.2.4 For working in decontamination room and washing area, wear hand gloves covering hands up to elbow.
6.2.2.5 Transfer the surface disinfected samples for sterility, media plates for environmental monitoring etc. to sterile buffer room through Dynamic pass box I.D. No. QCDPB-01.
6.2.2.6 Subject the materials in DPB to UV Light exposure for 30 minutes.
6.2.3 Exit:
6.2.3.1 Open the exit door of the Air lock and enter the Air Lock.
6.2.3.2 Remove and put the gloves (used in the decontamination and washing room) into Bio-hazard bag for decontamination.
6.2.3.3 Remove the face mask and put it into the dust bin.
6.2.3.4 Open the exit door and enter in to the General corridor.
6.3 Microbiology laboratory – Sterility Testing and Agar Plates preparation Area:
6.3.1 Microbiology laboratory – Sterility Testing Areas include, Change room-I, Change room-II, Change room-III, Change room-IV, Sterility Testing room, Sterile buffer room, Return buffer and Return Air Lock.
6.3.2 Entry:
6.3.2.1 Show access card to inter locking system or Press the interlocking button to enter into Change room-I of Sterility testing area.
6.3.2.2 Remove the Apron, Cap and Street garments. Remove the Lab Slippers and keep aside. Place Apron, Cap and Street garments in the dedicated Street Garment cubicle.
6.3.2.3 Sanitize the hands up to the elbow with 70% IPA provided in the Change room-I.
6.3.2.4 Press the interlocking button and enter in to Change room-II, by opening the door with the help of elbow.
6.3.2.5 Sanitize the hands up to the elbow with Sterillium provided in the Change room-II.
6.3.2.6 Take out a fresh set of Primary Garment (which comprises of Headgear, jacket, trouser and booties) from the Primary Garment box.
6.3.2.7 Wear the headgear followed by jacket, trouser and booties sequentially.
6.3.2.8 Enter into Change room-III, by pressing the interlocking button and opening the door with the help of elbow.
6.3.2.9 Sanitize the hands with 70% IPA provided in the Change room-III.
6.3.2.10 Switch OFF the Germicidal light (UV light) of Sterile Garment Cubicle and open the door.
6.3.2.11 Pick and wear a pair of sterile gloves aseptically. Sanitize the gloved hands with 70% IPA.
6.3.2.12 Pick up a bag of Sterile Garment containing head gear, boiler suit. Open the Sterile Garment bag and wear the headgear first followed by boiler suit and booties.
6.3.2.13 Tie the boiler suit over the belly with the help of the string provided in the inner portions of the garment.
6.3.2.14 Ensure that any part of Sterile Garment is not to touch the floor. Take care that the hands shall not touch the outer surface of the garment.
6.3.2.15 Close the garment from top to bottom with the help of the zipper.
6.3.2.16 Wear the booties.
5.3.2.17 Sanitize the hands with 70% IPA.
6.3.2.18 Wear disinfected Goggles.
6.3.2.19 Sanitize the hands with 70% IPA.
5.3.2.20 Wear a second pair of sterile gloves.
6.3.2.21 Sanitize the hands with 70% IPA.
6.3.2.22 Press the interlocking button and push the door of Change room-IV with the help of elbow and enter.
6.3.2.23 Check yourself in the mirror for proper gowning.
6.3.2.24 Wear dedicated Aseptic area slippers.
6.3.2.25 Press the interlocking button and push the door of the Sterility Testing room with the help of the elbow and enter.
6.3.2.26 From there enter into different rooms of the Sterility Testing Area, as per requirement.
6.3.2.27 Receive the surface disinfected samples for Sterility, media plates for environmental monitoring etc. to sterile buffer room through Dynamic pass box I.D. No. QCDPB-01.
6.3.2.28 Transfer the Sterilized items used for Sterility Testing like Media, Filtration units, sterile petridishes etc., and Samples for sterility, media plates for environmental monitoring etc. to Sterility Testing room by S.S. trolley provided.
6.3.2.29 Transfer the Sterilized items like Sterile Garments used for Sterility testing area through Dynamic pass box I.D. No. QCDPB-02 and Sterile items used for MLT and Subculture like Media, Sterile garments, Filtration units etc. through Dynamic pass box I.D. No. QCDPB-03.
6.3.2.30 After completion of Sterility test / Disinfectant preparation/ Cleaning, carry all the used articles like Sterility test containers/ tubes, empty media bottles, Prepared Agar media plates, manifolds, filtration assembly etc. to sterile buffer room using the SS trolley. From there transfer them to Sterilization areas, through Dynamic pass box I.D. No. QCDPB-01.
6.3.3 Exit:
6.3.3.1 After completion of work, pick and carry all the wrappers like parchment paper, PP bags and sample vials etc. collected in waste bag. Put the Waste bag in the Bin in Testing area to get collected by the person going in for cleaning.
6.3.3.2 Press the interlocking button and pull the exit door and enter in to the Return buffer.
6.3.3.3 Press the interlocking button and pull the exit door and enter in to the Return Air lock.
6.3.3.4 Press the interlocking button and pull the exit door and enter in to the Change room-I.
6.3.3.5 Leave the dedicated Aseptic area slippers. Remove the Sterile Garment and dedicated inner garments and put them in to the Used Garment box.
6.3.3.6 Wear the Street garments, Apron, Cap and lab Slippers.
6.3.3.7 Press the interlocking button and pull the exit door of Change room-I and leave from the room.
6.3.3.8 Put the waste bag in the waste bin provided in General Corridor.
6.4 Microbiology laboratory – MLT Section:
6.4.1 Microbiology laboratory – MLT Section include, Change room, MLT section corridor, Subculture / BET test room and MLT room.
6.4.2 Entry:
6.4.2.1 Push the entry door and enter into Change room of MLT Section.
6.4.2.2 Remove the Lab Slippers and keep aside.
6.4.2.3 Remove the Apron and cap and place them in the dedicated garment box provided.
6.4.2.4 Cross over the COB (Cross over Bench).
6.4.2.5 Sanitize the hands up to the elbow with Sterillium provided.
6.4.2.6 Switch OFF the Germicidal light (UV light) of Sterile Garment Cubicle and open the door.
6.4.2.7 Pick and wear a pair of sterile gloves aseptically. Sanitize the gloved hands with 70% IPA.
6.4.2.8 Pick up a bag of Sterile Garment containing head gear, boiler suit. Open the Sterile Garment bag and wear the headgear first followed by boiler suit and booties.
6.4.2.9 Tie the boiler suit over the belly with the help of the string provided in the inner portions of the garment.
6.4.2.10 Ensure that any part of Sterile Garment does not touch the floor. Take care that the hands shall not touch the outer surface of the garment.
6.4.2.11 Close the garment from top to bottom with the help of the zipper.
6.4.2.12 Wear the booties.
6.4.2.13 Sanitize the hands with 70% IPA.
6.4.2.14 Wear a second pair of sterile gloves.
6.4.2.15 Sanitize the hands with 70% IPA.
6.4.2.16 Wear dedicated Aseptic area slippers.
6.4.2.17 Receive the Sterilized items used for MLT and Subculture, Sterile garments, Filtration units etc. through Dynamic pass box I.D. No. QCDPB-03.
6.4.2.18 Receive the surface disinfected samples for MLT, articles required for GPT, articles required for BET test, Sub-culture tubes, Plates used for Environmental Monitoring etc. through Static pass box I.D. No. QCSPB-01.
6.4.2.19 Pull and enter the testing rooms as per the requirement, along with articles received.
6.4.3 Exit:
6.4.3.1 After completion of test / Cleaning, carry all the used articles like test containers/ tubes, empty media bottles, manifolds, filtration assembly etc. and also carry the waste bag containing all the wrappers like parchment paper, PP bags and sample vials to MLT corridor.
6.4.3.2 Push the exit door and enter into the MLT corridor from testing room.
6.4.3.3 From there transfer the used articles to Incubators room, through Static Pass box I.D. No. QCSPB-01.
6.4.3.4 Leave the dedicated Aseptic area slippers.
6.4.3.5 Cross over the COB (Cross Over Bench) along with waste bag.
6.4.3.6 Remove the Sterile Garment and put them into the Used Garment box.
6.4.3.7 Put the waste bag in the waste bin provided in Change room.
6.4.3.8 Pull the exit door of Change room and leave from the room.
6.5 Precautions to be taken in Testing Areas:
6.5.1 Do not talk or sneeze or Cough in testing area.
6.5.2 Do not touch any walls and other surfaces with hands. Touch or handle only when necessary.
6.5.3 Do not make rapid movements.
6.5.4 Do not look at the U.V. Lights with unaided eyes.
6.5.5 Do not wear any jewelry and other ornaments while entering in to the testing areas.
6.5.6 Personnel suffering with illness must not enter the testing areas and must report to head, who will appropriately assign other duties.
7.0 List of Annexure / Formats:
Not applicable
8.0 References (if any):
Not applicable
9.0 Distribution
7.1 Master Copy : Documentation Cell (Quality Assurance)
7.2 Controlled Copies : Quality Assurance, Microbiology-QC, Quality Control, Production- (Oral & Injectable), Pilot Plant, Warehouse, Engineering, Personnel & Administration, Regulatory Affairs
10.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
