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operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas

operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas

To lay down the procedure for operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas.

  • Scope

This SOP is applicable for operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas (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

QC                              : Quality Control

QA                              : Quality Assurance

MLT                            : Microbial Limit Test

  • Procedure
    • Operation
      • AHU should be switched OFF before fogging.
      • The room should be completely closed without any vent/opening and should be thoroughly cleaned.
      • Use 20% Virosil solution for fogging and pour into the fogger through the funnel provided on the tank lid as per Table-1.
      • Place the fogger at one corner of the room mounted at height of 2 feet and keeps the angle of the nozzle at 45 degrees with the help of adjustment knobs.
      • Adjust the timer switch of the fogger according to the volume of the dilution added (Refer Table-1).
      • Connect the Electrical cord of the fogger to the power supply and then switch on the mains.
      • Move out of the room and close the door completely and do not enter the room for minimum 40 minutes after the fogging has completed.
      • Switch ON the AHU not before 40 minutes has completed.
      • Record the details as per Annexure No. and put the label ‘Area Under Fogging’ as per Annexure No
    • Cleaning and maintenance:
      • Clean the fogger tank with purified water after every fogging operation by removing the tank from the blower.
      • Clean the nozzle hole with the help of the pin after every fogging operation.
      • Wash the Suction-air filter after every fogging operation, dry thoroughly and then replace it.
      • Thoroughly wipe the outer body of the fogger with plain cloth after successive fogging.
      • The nozzle hole needs to be cleaned after every fogging.
      • Do not touch the blower head while the fogger is in operation as it gets warmed up.
      • After every fogging add Purified water and then start the machine for 2 minutes for cleaning the inner tubes and nozzle to prevent it from getting choked.
      • Record the details as per Annexure No.only: If the condenser travel is excessive, limit the
    • Frequency:
      • Once in a week at the end of working hours.
    • Fogging of Microbiology Testing Areas:
      • Prepare the fogging solution as mention in Table-1.
      • Operate the fogger as per operating procedure mention in points 6.1.1 to 6.1.9.
      • Perform the fogging as per following sequence in Microbiology testing areas:
    • Sterility Testing Room:

Change Room 2    Change Room 3   Sterile Buffer Room Sterility testing Room Sterility Return Buffer Return Air Lock Change Room 1

  • MLT Room:

Sub-culture roomMLT testing room MLT Air Lock MLT Change room

  • Media decontamination room:

Media preparation room  Media decontamination roomSterilization Area and Air Lock

Table-I   Dilution and Use Volume of Virosil

Name of the Area Name of Fogging Solution Volume of fogging Solution Concentrate (ml) Volume of WFI / PW (ml) Total

Volume (ml)

Timer setting for fogging

(Minute)

Sterility Testing Room Virosil 200 800 1000 24
Sterile Buffer Room Virosil 200 800 1000 24
Sterility change Room-2, 3 and 4 Virosil 100 400 500 12
Sterility Return Buffer, Return Air Lock and Change Room-1 Virosil 100 400 500 12
Sub-culture Room Virosil 100 400 500 12
MLT Testing Room Virosil 100 400 500 12
MLT Air Lock and Change Room Virosil 200 800 1000 24
Media Preparation Room Virosil 100 400 500 12
Media Decontamination Room Virosil 100 400 500 12
Sterilization Area and Air Lock Virosil 200 800 1000 24

 

  • Forms and Records (Annexures)
    • Fogging Record
    • Label for Area Under Fogging
  • 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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