- Purpose: To lay down the Entry and Exit procedure into Microbiology laboratory.
- Scope: This Standard Operating Procedure is applicable at Microbiology section of Quality Control department
- References & Annexures:
- References: In House
- Annexures:
- Annexure-1: List of authorized person for Entry & Exit in Microbiology Laboratory.
- Responsibilities:
- Microbiologist / Executive – Quality Control.
- Shall be responsible for Entry and Exit procedure into MLT area in Microbiology lab.
- Quality Control (QC) Head.
- Ensure proper control and compliance of the SOP.
- Quality Assurance (QA) Department:
- To review the SOP.
- To ensure the implementation of SOP.
- Regulatory Affairs, Quality Head and Plant Head :
- To review and approve new or revised SOPs.
- Microbiologist / Executive – Quality Control.
- Distribution:
- QC
- QA
- Abbreviations and Definition of Terms :
- Abbreviations :
- CC : Change Control
- MLT : Microbial Limit Test
- NA : Not Applicable
- No : Number
- QA : Quality Assurance
- QC : Quality Control
- SOP : Standard Operating Procedure
- Definition of Terms :
- Standard Operating Procedure (SOP): A written authorized procedure, which gives instructions for performing operations.
- Abbreviations :
- Procedure:
- Entry Procedure for Staff in Microbiology Laboratory
- Enter the Quality control area as per SOP for Entry and Exit procedure in Quality Control Area.
- Remove the street footwear and put them in to dedicated rack provided for footwear.
- Cross over the Cross over Bench and wear the safety shoes or QC footwear to enter in to QC area.
- Open the door of almirah or cupboard of cleaned cloth/apron, take and wear the apron of Quality Control (which may of white color or which is dedicated for staff).
- Open the entry door and walk through the corridor to reach of microbiology section.
- Open the Door of Change room by pushing the door interlock button and enter inside into it.
- After entering the Change room, Remove the dedicated QC slippers and keep them in designated place.
- Cross over the bench and wear the dedicated slippers of microbiology laboratory.
- Push the interlock button to open the door of microbiology area general corridor,
- From Microbiology Lab General corridor, enter into different areas as required, following the described entry procedure of respective area.
- Dress Code of visitors : Full sleeve white visitor apron, White Cap, Blue Shoe cover and gray color sleepers / shoes.
- Dress Code of Lab Assistant: 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. Wear dedicated company dress in the change room after removing the street garments.
- Entry Procedure in to the MLT room of Microbiology Laboratory
- Take out the Apron, Cap &Sleeper/Shoes and place it on its defined place in the Air Lock-I.
- Sanitize the hands with the disinfectant provided in the Air Lock-I and cross the crossover bench.
- After crossing the crossover bench, personnel shall wear the slipper from the defined location of crossover bench and sanitize the hands with the validated disinfectant.
- Open the Door of Air Lock-II and Enter into Air Lock-II.
- Take the clean/sterile dress from dress cabinet provided in the Air Lock-II and open the dress pack which comprises of Boiler suit, Headgear and Booty.
- Take out the headgear holding from the folded position and wear it on the head taking care not to touch any other part of the headgear.
- Take out the Boiler suit from the pack and hold it a height preventing not to touch the floor.
- While holding the Boiler suit, care should be taken not to touch the inner portion of the suit.
- Wear it over the shoulders taking care that the frock portion of the head gear should be beneath the boiler suit/clean dress.
- Take the pair of booty and wear it.
- Take the pair of sterile gloves very carefully and wear it.
- Check in the mirror that gowning is proper.
- Disinfect the hands with the help of the disinfectant which is placed in the Air Lock-II.
- Push the door of the MLT area and enter into it.
- Exit Procedure from the MLT room of Microbiology Laboratory
- After completion of analysis, place all the unwanted material in the waste bin.
- Keep all the materials in the pass box.
- Open the door of the MLT room and enter into Air Lock-II.
- Remove the Gloves and place it in the waste bin which is placed in the Air Lock-II.
- Open the door and enter into Air Lock-I.
- Remove the booty first then the sterile/clean garment/boiler suit and headgear and place it in the defined place into the Airlock-I.
- Remove the sleeper and place it in the defined place in Airlock-I.
- Cross the crossover bench and wear the Lab shoe, apron & cap.
- Sanitize the hands with the disinfectant provided in the Air Lock-I and exit from the area.
- The entry and exit procedure shall be same for Male/Female, visitors, Microbiology Lab Assistant and Engineering person.
- Entry Procedure in to the Sterilization Area of Microbiology Laboratory
- Open the Air lock entry door of sterilization room and enter into the Air lock.
- Wear face mask.
- From Air lock enter in to different rooms of the sterilization area as per requirement.
- For working in decontamination room and washing area, wear hand gloves covering hands up to elbow.
- Transfer the surface disinfected samples for sterility, media plates for environmental monitoring etc. to sterile buffer room through Dynamic pass box.
- Place the materials in Dynamic Pass Box to UV Light exposure for 30 minutes.
- Perform the activity as required.
- Exit Procedure from the Sterilization Area of Microbiology Laboratory
- Open the exit door of the Air lock and enter the Air Lock.
- Remove and put the gloves (used in the decontamination and washing room) into Bio-hazard bag for decontamination.
- Remove the face mask and put it into the dust bin.
- Open the exit door and enter in to the General corridor.
- Entry Procedure in to the Sterility Testing and Agar Plates Preparation Area of Microbiology Laboratory
- Press the button of the interlocking system to enter into Change room-I of Sterility testing area.
- Remove the Apron, Cap and Street garments. Remove the Lab Slippers and keep at designated place. Place Apron, Cap and Street garments in the dedicated Street Garment Almirah.
- Sanitize the hands up to the elbow with 70% IPA provided in the Change room-I.
- Press the interlocking button and enter in to Change room-II, by opening the door with the help of elbow.
- Sanitize the hands up to the elbow with Sterillium provided in the Change room-II.
- Take out a fresh set of Primary Garment (which comprises of Headgear, jacket, trouser and booties) from the Primary Garment box.
- Wear the headgear followed by jacket, trouser and booties sequentially.
- Enter into Change room-III, by pressing the interlocking button and opening the door with the help of elbow.
- Sanitize the hands with 70% IPA provided in the Change room-III.
- Switch OFF the Germicidal light (UV light) of Sterile Garment Cubicle and open the door.
- Pick and wear a pair of sterile gloves aseptically. Sanitize the gloved hands with 70% IPA.
- 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.
- 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.
- Close the garment from top to bottom with the help of the zipper.
- Wear the booties and Sanitize the hands with 70% IPA.
- Wear disinfected Goggles and Sanitize the hands with 70% IPA.
- Wear a second pair of sterile gloves and Sanitize the hands with 70% IPA.
- Press the interlocking button and push the door of Change room-IV with the help of elbow and enter.
- Check yourself in the mirror for proper gowning.
- Wear dedicated Aseptic area slippers.
- Press the interlocking button and push the door of the Sterility Testing room with the help of the elbow and enter.
- From there enter into different rooms of the Sterility Testing Area, as per requirement.
- Receive the surface disinfected samples for Sterility, media plates for environmental monitoring etc. to sterile buffer room through first Dynamic pass box.
- 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.
- Transfer the Sterilized items like Sterile Garments used for Sterility testing area through second Dynamic pass box and Sterile items used for MLT and Subculture like Media, Sterile garments, Filtration units etc. through third Dynamic pass box.
- 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 first Dynamic pass box.
- Entry Procedure from the Sterility Testing and Agar Plates Preparation Area of Microbiology Laboratory
- 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.
- Press the interlocking button and pull the exit door and enter in to the Return buffer.
- Press the interlocking button and pull the exit door and enter in to the Return Air lock.
- Press the interlocking button and pull the exit door and enter in to the Change room-I.
- Leave the dedicated Aseptic area slippers. Remove the Sterile Garment and dedicated inner garments and put them in to the Used Garment box.
- Wear the Street garments, Apron, Cap and lab Slippers.
- Press the interlocking button and pull the exit door of Change room-I and leave from the room.
- Put the waste bag in the waste bin provided in General Corridor.
- Exit Procedure for Staff from Microbiology Laboratory
- Press inter locking button to open the change room door.
- Open the exit door of main entry change room and enter in to the first change room. 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.
- Cross over the COB (Cross over Bench) and wear dedicated QC slippers.
- Press the interlocking button and open the door leading to QC corridor.
- Open the door leading to exit from the QC.
- 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.
- Cross over the Bench and wear your own street footwear.
- Open the exit door and depart from the QC Department.
- In the case of Dedicated Factory Dress, remove the dress in the change room and wear the street garments.
- Don’t of Microbiology Laboratory
- Do not talk or sneeze or Cough in testing area.
- Do not touch any walls and other surfaces with hands. Touch or handle only when necessary.
- Do not make rapid movements.
- Do not look at the U.V. Lights with unaided eyes.
- Do not wear any jewelry and other ornaments while entering in to the testing areas.
- Personnel suffering with illness must not enter the testing areas and must report to head, who will appropriately assign other duties.
- Entry into Microbial testing area (MLT area) is restricted except authorized person as per Annexure-1.
- Visitor/Engineering person entered along with authorized person.
- Entry Procedure for Staff in Microbiology Laboratory
- History:
| Revision No | Effective Date | Revision Details | CC No |
Annexure-1: List of authorized person for Entry & Exit in Microbiology Laboratory
| <Logo> | <Company Name> |
| DEPARTMENT: MICROBIOLOGY | |
| LIST OF AUTHORIZED PERSON FOR ENTRY & EXIT IN MLT AREA |
| S.N. | Name of Person | Designation |
Prepared By: Approved By:
Date: Date: