Validation of Fumigation in Cleanroom Area : Pharmaceutical Guidelines

Validation of Fumigation in Cleanroom Area

Fumigation in cleanroom areas is done by fogging with hydrogen peroxide and it is validated with the bacterial spore strips.

Fumigation is the process to disinfect the sterile manufacturing and microbiology testing area. Generally, fumigation is not required when AHU runs continuously but when the microbial load increases in the controlled area it is controlled and minimized by fumigation of the area.

Fumigation Validation Spore Strips

Few year back fumigation was done by formaldehyde that is a strong disinfectant. Fumes were generated by the reaction of formaldehyde with the potassium permanganate or by the fogger. But formaldehyde is carcinogenic and has an adverse effect on the human health and also banned by regulatory agencies, therefore, this method is not used these days.

Fumigation is done to sterilize the air of cleanroom areas. Hydrogen peroxide (H2O2) is a perfect alternative of formaldehyde for fumigation. Fumigation process should be validated for its efficiency of removing the microbes from the air. 

Validation of fumigation is also required to verify the effectiveness of the fumigation. There are some indicators for the validation of fumigation efficiency in cleanroom areas. It is validated by the strip of Geobacillus 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 clean room especially at the critical locations as the corners and behind the equipment. After fogging in the room with Hydrogen Peroxide the strips are collected and incubated in the MC20 growth medium provided with the 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 the living microbes in the strips and shows the unsuccessful fumigation of the area. While no change in color of growth medium shows the effective fumigation of the area.



Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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