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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