Identification Methods for Bacteria and Fungi

Vikki Warren, Identification Services Manager The revised Annex 1 came into force on 25 August 2023. These guidelines apply to sterile medicinal product manufacture, and aim to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product. This is obviously an essential goal when it comes to sterile medicinal products, so the application of the guidelines to create an effective contamination control strategy is of paramount importance. With respect to the identification of microorganisms as part of the environmental monitoring programme, Annex 1 states that microorganisms detected in …

Need to identify Bacillus isolates as part of your environmental monitoring programme? Whole gene 16S sequencing can provide fast and accurate results

by Vikki Warren, NCIMB Identification Services Manager Identification of bacterial isolates provides vital information for pharmaceutical microbiologists undertaking environmental monitoring programmes within GMP production facilities, but some genera and species can be more tricky to identify than others. A commonly encountered example is identification of Bacillus species. Why 16S sequencing? At NCIMB we use 16S sequencing and the MicroSeq database to identify environmental isolates for our customers, because it has the potential to offer an unambiguous result – ultimately it is the DNA that defines the species. But what exactly …