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The document discusses the difference between fumigation and fogging, and validation of the fogging process. Fumigation uses formaldehyde and potassium permanganate, which are now banned. Fogging uses hydrogen peroxide and silver ion solution, which are safer and leave no residues. Validation of fogging involves placing bacterial spore strips in locations pre- and post-fogging, then incubating and checking for color change indicating microbial growth to verify fogging effectiveness.

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527 views

Micro

The document discusses the difference between fumigation and fogging, and validation of the fogging process. Fumigation uses formaldehyde and potassium permanganate, which are now banned. Fogging uses hydrogen peroxide and silver ion solution, which are safer and leave no residues. Validation of fogging involves placing bacterial spore strips in locations pre- and post-fogging, then incubating and checking for color change indicating microbial growth to verify fogging effectiveness.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Identification of Sampling Location for settle plate method during

bio load montoring of Production Area

The effectiveness of Settle plate technique which is employed for monitoring of bio load in
manufacturing area mainly depends upon the sampling locations chosen during the study.

The selection of sampling locations should be in such a way that the entire study which is
carried out reflects the true microbiological quality of the area under study.

The sampling location selected should be giving maximum number of air born particles on
the exposed media surface in the specified exposure time period.
Presently in the Settle plate technique, plate exposure locations are mainly the air outlets
where maximum recovery of bio load is expected. A plan has been designed in various
locations to find out the maximum recovery of bio load. Following are the locations
identified (which ever is applicable),
1. AHU inlets
2. Return air duct
3. Near to the drain trap
4. Personnel entry and exit ways
5. Material entry and exit ways
6. Pass box
A pair of culture media plates namely Soybean casein digest agar and sabouraud dextrose
agar shall be exposed at each of the above listed sampling location for a period of 4 hours.
These Soybean casein digest agar and sabouraud dextrose agar plates shall be incubated at
37°C± 2°C for not less than 3 days and 22°C ±2°C for not less than 5 days respectively to
allow the growth of the microorganisms.

This entire study shall be carried out for five working days to optimize to get the trend.
Based on the trends of results, evaluation of the various sampling locations chosen shall be
done for suitability in Settle plate technique as a regular sampling location.

Difference Between Fumigation and Fogging and Validation of Fogging


in Cleanroom
Fumigation and fogging are two methods commonly used in pharmaceutical companies to control the
microbial contamination in controlled area. But now a day’s fumigation of formaldehyde solution
(HCHO) and potassium permanganate is banned by different regulatory agencies.
Fumigation and Fogging:
Fumigation: Fumigation is a method in which we use formaldehyde solution with potassium
permanganate chemical in a predefined ratio. Formaldehyde is a strong disinfectant. By adding
potassium permanganate in formaldehyde a reaction take place and generate fumes. Generated fumes
kill bacteria, fungus and their spores.
This is very effective method to control the microbial contamination in cleanroom.

Why Ban Fumigation by different Regulatory agencies: (Fact Sheet)


Different regulatory agencies banned fumigation with formaldehyde and potassium permanganate
after having so much effectiveness. The reason is that formaldehyde is carcinogenic (cancer causing)
in nature and there is a risk of cancer associated with this to the personal who is handling
formaldehyde. There are also other drawbacks like fumigation with formaldehyde cause irritation to
the eyes and nose. After fumigation there is requirement to de-fumigation of the area in which air-
handling unit (AHU) has to be continuously run for few hours without any activity to remove the
residues from the air and cleaning and moping of equipment’s and area is also required.

Why Hydrogen peroxide?


In case of Hydrogen peroxide and silver ion solution, it is safe for the personal and no-residue left
after fogging as it decompose in the water and nascent oxygen. There is no requirement of defogging
and cleaning of equipment’s and no need to remove the residue of the solution.

Fogging: Now a days fogging is used in pharmaceuticals to control the microbial contamination in
controlled area. Fogging done with the help of fogger machine and a fogging solution.
Different disinfectants are also used for fogging as claim by the vendor which can effectively control
the area.
Now, in Most of pharmaceutical industries commonly uses hydrogen peroxide and silver ion solution.

(ULV) Ultra low volume foggers are generally used for fogging. By these fogger machine solution is
sprayed in the area in form of aerosol. The small particles of disinfectant solution suspended in air for
long time and kill all the airborne bacteria, fungus and their spores. This is also very effective method
to control the microbial contamination in controlled area.

Why need fogging?


Fogging is done to sterilize the air of controlled areas. Generally fogging is not required when AHU
runs continuously but when the microbial load increase in the controlled area it is controlled by
fogging the area. Mainly sterile manufacturing and microbial testing area need to fogging.

Validation of Fogging Process:


Fogging process should be validated for its efficiency of removing the microbes from air. It is validate
with the bacterial spore strips.

Validation of fogging is also required to verify the effectiveness of the fogging. There are some
indicators for the validation of fogging efficiency in controlled areas. It can be validated with the help
of strip of Geobacillius stearothermophillus ATCC 7953. These strips are manufactured by
TERRAGENE SA (Argentina) with the product name BIONOVA. These are perforated stainless steel
coupons having spores.

BIONOVA spore coupons biological indicators are placed at the different locations in the controlled
areas especially at the critical locations as the corners and behind the equipments. After fogging the
room these strips are collected and incubated in the MC20 growth medium provided with biological
indicators at 60±2°C for 24 hours.
Validation Criteria:
The color of MC20 growth medium should not be changed to yellow after incubation at 60±2°C.
Change in color of growth medium indicates the presence of living microbes in the strips and shows
the unsuccessful of the process. While no change in color of growth medium shows the effective
fogging of area.

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