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Fogging of Microbiology Testing Areas

Fogging of Microbiology Testing Areas

  • Fogging of Microbiology Testing Areas
  • Objective

To lay down the procedure for Fogging of Microbiology Testing Areas.

  • Scope

This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory of (Pharmaceutical Company Name).

  • Responsibility
    • Chemist or above of Microbiology Laboratory.
    • Head – Microbiology Section.
  • Accountability
    • Head – Quality Control.
  • Abbreviations and Definitions

SOP           : Standard operating procedure

No.             : Number

QC             : Quality Control

QA             : Quality Assurance

SS              : Stainless Steel

MLT          : Microbial Limit Test

  • Procedure
    • Operation
      • Perform the Fogging of Microbiology once in a week at the end of working hours
      • Perform the fogging on below mentioned areas on different days
    • Sterility testing area
    • MLT, Subculture room and MLT section corridor and Change room.
    • Sterilization area
      • Make sure that the area is thoroughly cleaned before fogging.
      • Close all the dampers.
      • Switch off all the AHU.
      • Enter into the area to be fogged as per the SOP No.along with the fogger (Micro mist and Nanotech) filled with the required quantity of dilute disinfectant.
    • Sterility testing area:
      • Switch off the interlocking of the sterility testing area.
      • Enter into change room-4 as per the SOP No for the area along with the fogger filled with dilute Virosil.
      • Keep the doors between change room-2 & 3 and change room 3 & 4 open.
      • Place the fogger in one corner of change room-4.
      • Adjust the motor angle at 45˚C and the timer to 0.5 liter.
      • Connect the power cord of the fogger to the mains and switch on the fogger and quickly move out of the room into the sterility room and close the door.
      • Wait in the sterility room for the fogging to complete.
      • As soon as the fogging is complete, quickly transfer the fogger from change room-4 to Sterile Buffer room and place similarly.
      • Adjust the timer to around 0.7 liter.
      • Connect the fogger power cord to the mains and switch on the mains and quickly move out of the room into the sterility test room.
      • Wait for the fogging to complete.
      • As soon as the fogging is complete, quickly transfer the fogger from Sterile Buffer room to Sterility test room and place it similarly.
      • Adjust the timer to around 0.7 liter.
      • Connect the fogger power cord to the mains and switch on the mains and quickly move out of the room into the Return Buffer room and close the door.
      • As soon as the fogging is complete remove the fogger from the sterility test room and then place the fogger in change room-1.
      • Keep the doors between Return buffer & Return A/L and Return A/L & Change room-1 open.
      • Connect the fogger power cord to the mains and switch on the mains and quickly move out of the room into the Microbiology corridor and close the door.
      • Place a tag “Area under Fogging” as per Annexure No on the entry door and leave the area undisturbed for overnight.
    • MLT Section:
      • Switch off the AHU of the MLT Section.
      • Enter into the MLT Section as per the entry SOP No. along with the fogger.
      • Enter the Subculture room and place the fogger in one corner on a SS stool and connect the power cord of the fogger to the mains.
      • Adjust the timer of the fogger to 0.5 liter and switch on the mains.
      • Quickly move out of the room, close the door properly and wait in the change room till the fogging is completed.
      • As soon as the fogging is completed quickly take the fogger out of the subculture room and then fog the MLT room using the same procedure.
      • After the fogging is complete in the MLT room quickly take out the fogger from the
      • MLT room and place it in one corner of the change room on a SS stool.
      • Adjust the motor angle at 45˚C and the timer to 1.0 liter.
      • Connect the power cord of the fogger to the mains and switch on the mains and quickly move out of MLT section.
      • Place a tag “Area under Fogging” as per Annexure No. on the entry door and leave the area undisturbed for overnight.
    • Sterilization area:
      • Switch off the AHU of the Sterilization area.
      • Enter into the Sterilization area as per the entry SOP No along with the fogger.
      • Enter the Media decontamination room and place the fogger in one corner on a SS stool and connect the power cord of the fogger to the mains.
      • Adjust the motor angle at 45˚C and the timer to 0.5 liter.
      • Switch on the mains and quickly move out of the room.
      • As soon as the fogging is completed quickly take the fogger out of the Media decontamination room and then fog the Media preparation room, following the same procedure.
      • After the fogging of the Media preparation room, quickly take out the fogger and place in one corner of the sterilization room on a SS stool.
      • Adjust the motor angle at 45˚C and the timer to 1.0 liter.
      • Switch on the mains and quickly move out of the room.
      • Place a tag “Area under Fogging” as per Annexure No. on the entry door and leave the area undisturbed for overnight.
      • Dilute and use required volume of Virosil as per Table-I.
      • Pour the prepared disinfectant solution in to the tank of fogger prior to entering the area to be fumigated.
      • Operate the fogger as per SOP No.:
      • Come out of the room using exit process of the particular area.
      • Put the label as ‘Area under Fogging’. Keep the area under this condition for overnight.
      • In the next day morning, switch on the AHU. Open the dampers.
      • Enter the area as per respective entry procedure. Close all the doors. Remove the Fogging set and exit along with the set.
      • Record the fogging details as per Annexure No.:

 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)

Sterility Testing room Virosil 150 600 750
Sterile Buffer room Virosil 150 600 750
Change rooms-2, Change room-3 and Change room-4 Virosil 100 400 500
Return Buffer, Return A/L and Change room-1 Virosil 100 400 500
Sub-culture room Virosil 100 400 500
MLT room Virosil 100 400 500
MLT A/L and Change room Virosil 200 800 1000
Media decontamination room Virosil 100 400 500
Media preparation room Virosil 100 400 500
Sterilization area and Washing area Virosil 200 800 1000

 

  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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