Fumigation & Operational Procedure of Decontaminators




Fumigation & Operational Procedure of  Decontaminators

1.     Purpose:-

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

2.     Scope:-

2.1.      This Procedure is followed for preparation of “Microbiological lab.”
3.     HSE Statement:-                                  

3.1.      Follow the following instructions to perform fumigation in safe manners.
§   Wear 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 supervisor.

4.     Responsibilities:-               

Ø  Lab assistant is responsible to conduct assigned tasks in safe manners and report to supervisor in case of any problem.
Ø  Officer /Microbiologist is responsible to monitor fumigation process.

5.     Materials:-                         

                    i.                 S.S Jar
                  ii.                 Decontaminator (Hot Plate)
                iii.                 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:-           

Chapter No.
Process Flow Chart
Description
Responsibilities


8.1



8.2



8.3








Prepare Fumigation Solution



Operate Decontaminator to fumigate the aseptic area

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




§ Fumigation Solutions:
§ Operation of Decontaminators
§ Fumigation Process:
§ Precautions:-

§  Lab assistant
§  Microbilogist


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 hot plate.
§    Connect the Hot Plate with electricity supply, set the regulator to 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 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 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 Microbiologist.
8.4.2.      Measure the exact quantities of chemical as per 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




11.            Revision History:-                  |

Date                                        Changes

N/A


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