1.0 Objective:
To lay down the procedure for Cleaning and Disinfection of microbiology lab.
2.0 Scope:
This SOP is applicable for Cleaning and Disinfection of microbiology lab of pharmaceuticals formulation plant.
3.0 Responsibility:
Microbiologist or above of Microbiology Laboratory.
Head – Microbiology section / Nominee.
4.0 Accountability:
Head – Quality Control / Nominee.
5.0 Abbreviations:
- SOP : Standard operating procedure
- : Number
- QC : Quality Control
- QA : Quality Assurance
- MLT : Microbial Limit Test
- V/V : Volume by Volume
- S : Stainless steel
- LAF : Laminar Air Flow
- IPA : Isopropyl Alcohol
- WFI : Water for injection
6.0 Procedure:
6.1 The Microbiology lab consists of following areas :
6.1.1 General Microbiology Lab – Microbiology entry air lock, Microbiology general corridor, Microbiology Sterilization area, Media preparation area, Washing area, Media decontamination area, Microbiology office, Incubator room & Glassware storage room.
6.1.2 Sterility testing area – Change room 1, Change room 2, Change room 3, Change room 4, Sterility Testing room, Sterile Buffer Room, Return Buffer and Return Air Lock.
6.1.3 MLT Section – MLT A/L & Change room, MLT room and Subculture room.
6.1.4 Clean and disinfect all areas of microbiology lab twice a day (Morning and evening).General Microbiology
6.2 General Microbiology Lab :
6.2.1 Using a lint free mopping duster remove dust from all surfaces of COB, doors, window glasses, walls, incubator surfaces, grills, external surfaces of equipment like ovens, autoclave, refrigerator, weighing balance, pH meter, water bath, Tables etc.Sweep the floor to remove the dust using
6.2.2 Sweep the floor to remove the dust using non-shedding lint-free dry mop.
6.2.3 Take two buckets, add purified water in one bucket, and dilute disinfectant solution in another bucket as per respective SOP.
6.2.4 Wipe the cleaned surfaces first with mopping cloth wetted with purified water and then with dilute disinfectant.
6.2.5 Clean the drains, sinks and wash basins with purified water daily once followed by flushing with disinfecting solution.
6.2.6 Clean and sanitize the media preparation table and washing area table with 70% IPA solution.
6.2.7 Empty the waste bins twice daily and clean the bins with water and disinfectant solution.
6.2.8 Remove the dust from the ceiling, shelves, ducts, lights, fixtures, racks etc., using vacuum cleaner monthly.
6.2.9 Wipe the floor with the floor cleaning solution.
6.2.10 Clean the S.S. Garment and shoe cabinet present in the primary change over area daily using a clean dry cloth.
6.2.111 Record the details of cleaning in cleaning and sanitization of microbiology lab Annexure No.-I.
6.2.12 List of Disinfectant to be used:
a. Lysol – 2.5% v/v
b. Domex-2.5% v/v
c. Savlon-2.5% v/v
Sequence of rotation: On weekly rotation; one disinfectant for a week.
Frequency of cleaning – twice a day.
6.3 Sterility testing area:
6.3.1 Clean and disinfect the Garment cabinet and the used garment cabinet present in the Change room-1 with a lint free cloth wetted with 70 % IPA.
6.3.2 Clean the floor, glass surfaces, LAF hood with WFI and wipe with sterile lint free mop pads.
6.3.3 Sprinkle the disinfectant on the floor and spread with sterile lint free mop pads.
6.3.4 Allow for the contact period of 10 minutes.
6.3.5 Wipe out the excess disinfectant with the sterile lint free mop pads using a long handled SS mop.
6.3.6 Follow the above steps in a sequence from testing room to change rooms.
6.3.7 Sanitize the dedicated slippers with the same disinfectant as used for the floor daily by dipping them in disinfectant and allowing the contact period of 10 minutes. After completions of the contact period dip in WFI, spray 70% IPA and allow drying.
6.3.8 Clean the autoclave door, Garment cabinet, pass box daily with 70% IPA solution.
6.3.9 Clean all the surfaces, trolleys and SS furniture daily with the disinfectant.
6.3.10 Change the disinfectants every week and use in rotation as below.
6.3.11 List of Disinfectant to be used:
a. Triple 100 1% v/v
b. Combatan DS 1% v/v
c. Protasan DS 1% v/v
Sequence of rotation: On weekly rotation ; one disinfectant for a weekly
Frequency of cleaning – twice a day.
6.3 MLT Section:
6.3.1 Clean and disinfect the used garment box and the cross over bench daily with 70 % P.A.
6.3.2 Clean the floor, glass surfaces, LAF hood with WFI and wipe with sterile lint free mop pads.
6.3.3 Sprinkle the disinfectant on the floor and spread with sterile lint free mop pads.
6.3.4 Allow for the contact period of 10 minutes.
6.3.5 Wipe out the excess disinfectant with the sterile lint free mop pads using a long handled SS mop.
6.3.6 Sanitize the dedicated slippers with the same disinfectant as used for the floor daily by dipping them in disinfectant and allowing the contact period of 10 min. After completion of the contact period dip in WFI, spray 70% IPA and allow to dry.
6.3.7 Change the disinfectants every week and use in rotation as below.
6.3.8 List of Disinfectant to be used:
a. Triple 100 1% v/v
b. Combatan DS 1% v/v
c. Protasan DS 1% v/v
Sequence of rotation: On weekly rotation; one disinfectant for a week.
Frequency of cleaning – twice a day.
6.4 Use Cidex for spraying in testing areas weekly once.
6.5 Record the details of cleaning and disinfection of as per Annexure No. QCSP305/A01.
7.0 List of Annexure / Formats:
Cleaning and disinfection of microbiology lab
8.0 References (if any):
SOP on Preparation and Usage of Disinfectants
SOP on Disinfectant Usage Policy
9.0 Distribution
7.1 Master Copy : Documentation Cell (Quality Assurance)
7.2 Controlled Copies : Quality Assurance, Microbiology-QC
10.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Record for Cleaning and Disinfection of Microbiology Lab
Date: _____________________
| Area | Cleaned with | Disinfected by | Disinfectant Ref. No. | Done by / Time | Checked by | Remarks |
| Microbiology Entry air lock and General Corridor | ||||||
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| Microbiology Sterilization area
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| Media preparation Room
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| Washing Area
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| Decontamination Area
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| Incubators room
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| Microbiology Office
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| Glass ware Storage room
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| Sterility Testing Area
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| MLT Section
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Frequency: Daily twice
