Handle Microbial Cultures in Separate Room : Pharmaceutical Guidelines

Handle Microbial Cultures in Separate Room

Contamination of sample with the positive control and cultures can be prevented using separate area for culture handling.
Separate laminar air flow unit in a separate room for the handling of microbial cultures is a new trend in pharmaceuticals nowadays. Before some time all microbiological activities were done under same laminar airflow bench including positive cultures, sub-culturing, sample preparation and analysis. But now it is changing to have a separate area for culture handling and sample analysis.

Layout
The idea behind the separate area for these activities is the possibilities of contamination of the positive cultures in the samples causing the inaccurate results. Both of the rooms should not be separated only by a single door

These may open in a common corridor but the room dedicated to culture handing should have less pressure than the corridor. It is done to prevent the entrance of the contamination from culture handling room to the corridor and further possibility to enter in sample analysis room.


No regulatory agency has this concept in written but it has been seen many times that Food & Drug Administration (US-FDA) and Medicines & Healthcare products Regulatory Agency (MHRA) auditors ask to have the separate room and laminar air flow for sub-culturing and preparation of positive controls.


Positive controls should also be transferred in incubator room through separate passbox. Pathogen and other cultures should not be opened or used in other areas of the laboratory except dedicated culture handling area, washing and decontamination area.

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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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