Handle Microbial Cultures in Separate Room

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.

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.

Related: Layout for Injection Manufacturing Unit

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.

Related: Is Fungal Count Acceptable in Pharmaceutical Classified Area?

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.