Fumigation Decontamination SOPs is created for clearance of microbial contamination.

1.  Purpose:-

1.1.This procedure is developed to clear the area from microbial contamination.

2.  Scope:-

2.1.This Procedure is followed for the preparation of the “Microbiological lab.”

3.  HSE Statement:-                                  

3.1.Follow the following instructions to perform fumigation in safe manner.
  • Wear a safety mask & gloves before preparing strong germicidal solutions.
  • Only trained and knowledgeable persons perform fumigation.
  • All work is performed in accordance with applicable regulatory requirements.
  • Report any job-related injuries or illnesses, questions on health and safety, or any unsafe or unhealthy working conditions to the supervisor.
4.   Responsibilities:-               
  • Lab assistant is responsible to conduct assigned tasks in safe manners and report to supervisor in case of any problem.
  • The officer / Microbiologist is responsible to monitor the fumigation process.
5.     Materials:-     
  • S.S Jar
  • Decontaminator (Hot Plate)
  • Fumigation Solution
6.     Definition:-                       

6.1.   Fumigation

Fumigation is the process which is used for the killing of microorganisms, Insects.

6.2.   Decontaminate

To render (an area, building, object, etc) harmless by the removal, distribution, or neutralization of poisons, radioactivity.

6.3.   Microbial Contamination
Microbiological contamination refers to the non-intended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, prisons, protozoa or their toxins and by-products

7.     Flow Chart:-      

No

Process Flow Chart

Description

Responsibilities

8.1

Prepare Fumigation Solution

Fumigation Solutions:

Lab assistant

Microbiologist

8.2

Operate Decontaminator to fumigate the aseptic area

Operation of Decontaminators

8.3

Fumigate the aseptic area on weekly basis or after major maintenance work / civil work in the area in the presence of section Supervisor

Fumigation Process:

Precautions:-



8.     Description:-

8.1.   Fumigation Solutions:

I)     Glutaraldehyde 2%

        Glutaraldehyde                        «        10 ml              
        Water for injection Q.S             «        500ml
        Decontaminator                       «        Hot Plate.

II)        Biocide 25%

        Biocide                                    «         125ml 
        Water for injection QS               «         500ml
        Decontaminator                        «        Hot Plate


8.2. Operation of Decontaminators
 
8.2.1. Hot Plate

  • Put the solution in SS Jar container and place it on a hot plate.
  • Connect the Hot Plate with the electricity supply, set the regulator to the required temperature.
  • Switch on the Hot Plate when required.

8.3.         Fumigation Process:

8.3.1.      Put the solution in SS Jar container and place it on Hot Plate.
8.3.2.      Place the Hot Plate in the center of the area, to be fumigated.
8.3.3.      Connect power to the electricity supply for fumigator, which will be 
               operated from outside the aseptic area.

8.3.4.      After connection check it for proper functioning than evacuate the area, lock and seal the main door.
8.3.5.      Be sure that no person should be present in the aseptic area during fumigation.
8.3.6.      Switch off the Air handling unit for at least four hours so that the area should be in contact with fumigant solution.
8.3.7.      After completion of sterilization cycles of Autoclave and oven, switch on the Hot Plate.
8.3.8.      When the fumigation time is completed, switch off the Hot Plate and turn on the Air Handling Unit and wait for the complete removal of fumes from area.
8.3.9.      When it is safe to enter the aseptic area, remove Hot Plate from the sterile area.
8.3.10.  Start the Filling after approval from QC & QA.
8.3.11.  Carry out the Fumigation on daily basis (before filling) in dry powder and on weekly basis in Liquid Injectable section. Fumigation is to be carried out also after any major maintenance work, after a long shutdown when required by circumstances.               |

8.4.         Precautions:-

8.4.1.      Process of filling Hot Plate should be carried out in the presence of a Microbiologist.
8.4.2.      Measure the exact quantities of chemicals as per the formula
8.4.3.      Use funnel to avoid splashing of chemicals.
8.4.4.      Before fumigation, ensure complete cleaning and mopping of floors, walls and machine with disinfectant.
8.4.5.      Open all the cabinets of the machine and inner door of pass through to have thorough exposure during fumigation.     

9.     Reference:-

9.1.      *USP 36 Edition Volume I

10.            Distribution:-               

Sr. #
Distributed to
Received (Current)
Returned (Obsolete)
01
Quality ControlDepartment



02
Quality Assurance Department 



03
Quality Management Department