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SOP On Cleaning and Disinfection of microbiology lab

Objective

To lay down the procedure for Cleaning and Disinfection of microbiology lab.

  • Scope

This SOP is applicable for Cleaning and Disinfection of microbiology lab of (Pharmaceutical Company Name).

  • Responsibility
    • Microbiologist or above of Microbiology Laboratory.
    • Head – Microbiology section / Nominee
  • Accountability
    • Head – Quality Control / Nominee.
  • Abbreviations and Definitions

SOP         : Standard operating procedure

No.           : Number

QC           : Quality Control

QA           : Quality Assurance

MLT         : Microbial Limit Test

V/V           : Volume by Volume

S.S           : Stainless steel

LAF         : Laminar Air Flow

IPA           : Isopropyl Alcohol

WFI         : Water for injection

  • Procedure
    • Microbiology lab consists :
      • 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.
      • 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.
      • MLT Section – MLT A/L & Change room, MLT room and Subculture room.
      • Clean and disinfect all areas of microbiology lab twice a day (Morning and evening).
    • General Microbiology Lab :
      • 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 non-shedding lint-free dry mop.
      • Take two buckets in which add purified water in one bucket and add dilute disinfectant solution in another bucket.
      • Mop the surfaces with cloth that is wetted purified water after that mop with dilute disinfectant.
      • details of Microscope as per the annexure in SOP No.
      • Clean the drains, sinks and wash basins with purified water  after flushing with disinfecting solution at frequency daily.
      • Clean and sanitize the media preparation table and washing area table with 70% IPA solution.
      • Empty the waste bins twice daily and clean the bins with water and disinfectant solution.
      • Remove the dust from the ceiling, shelves, ducts, lights, fixtures, racks etc., using     vacuum cleaner monthly.
      • Wipe the floor with the floor cleaning solution.
      • Clean the S.S. Garment and shoe cabinet present in the primary change over area   daily using a clean dry cloth.
      • Record the details of cleaning in cleaning and sanitization of microbiology lab Annexure No.
      • List of Disinfectant to be used:
  1. Lysol – 2.5% v/v
  2. Domex-2.5% v/v
  3. Savlon-2.5% v/v

Sequence of rotation: On weekly rotation; one disinfectant for a week.

Frequency of cleaning – twice a day.

  • Sterility testing area:
    • 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.
    • Clean the floor, glass surfaces, LAF hood with WFI and wipe with sterile lint free mop pads.
    • Sprinkle the disinfectant on the floor and spread with sterile lint free mop pads.
    • Allow for the contact period of 10 minutes.
    • Wipe out the excess disinfectant with the sterile lint free mop pads using a long   handled SS mop.
    • Follow the above steps in a sequence from testing room to change rooms.
    • 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.
    • Clean the autoclave door, Garment cabinet, pass box daily with 70% IPA solution.
    • Clean all the surfaces, trolleys and SS furniture daily with the disinfectant.
    • Change the disinfectants every week and use in rotation as below.
    • List of Disinfectant to be used:
  1. Triple 100 1% v/v
  2. Combatan DS 1% v/v
  3. Protasan DS 1% v/v

Sequence of rotation: On weekly rotation; one disinfectant for a weekly

Frequency of cleaning – twice a day.

  • MLT Section:
    • Clean and disinfect the used garment box and the cross over bench daily with 70 % I.P.A.
    • Clean the floor, glass surfaces, LAF hood with WFI and wipe with sterile lint free mop pads.
    • Sprinkle the disinfectant on the floor and spread with sterile lint free mop pads.
    • Allow for the contact period of 10 minutes.
    • Wipe out the excess disinfectant with the sterile lint free mop pads using a long   handled SS mop.
    • 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.
    • Change the disinfectants every week and use in rotation as below.
    • List of Disinfectant to be used:
  1. Triple 100 1% v/v
  2. Combatan DS 1% v/v
  3. Protasan DS 1% v/v

Sequence of rotation: On weekly rotation; one disinfectant for a week.

Frequency of cleaning – twice a day.

  • Use of Cidex for spraying in testing areas is weekly .
  • Record the details of cleaning and disinfection of as per Annexure No.

 

  • Forms and Records (Annexures)
    • Cleaning and disinfection of   microbiology lab
  • Distribution
    • Master copy    –       Quality Assurance
    • Controlled copies     – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
  • History:
Date Revision Number
Reason for Revision
00   NEW SOP
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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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