Culture independent approach reveals domination of human-oriented microbes in a pharmaceutical manufacturing facility.

Culture independent approach reveals domination of human-oriented microbes in a pharmaceutical manufacturing facility. Eur J Pharm Sci. 2019 Jun 26;:104973 Authors: Kawai M, Ichijo T, Takahashi Y, Noguchi M, Katayama H, Cho O, Sugita T, Nasu M Abstract Strict microbial control is required in pharmaceutical manufacturing facilities, for which environmental microbial monitoring is fundamental. Appropriate microbial control is based on understanding the abundance and community structure of the microbes in the target environment, but most microbes are not culturable by conventional methods. Here, we determined the bacterial abundance and assessed the environmental microbiome in a pharmaceutical manufacturing facility using rRNA gene-targeted quantitative PCR (qPCR) and high-throughput sequencing of rRNA gene fragments. A commercially available microbial particle counter was also used for real-time measurements. In the air of the first gowning room and the passageway of the facility, the microbial particle number determined by both the particle counter and qPCR was ca. 104/m3; the number of microbial particles was about 100 times the number of culturable bacteria. Thus, the measurement of microbes using the particle counter was accurate. In the second gowning room of the facility, managed by a HEPA filter, the number of particles in the air was dependent on human movement, and was below the detection limit around 10 min after movement. ...
Source: European Journal of Pharmaceutical Sciences - Category: Drugs & Pharmacology Authors: Tags: Eur J Pharm Sci Source Type: research