Recovery of Burkholderia cepacia Complex Using Microsart Filter

This technical report investigates the recovery of Burkholderia cepacia complex (BCC) species using the Microsart® @filter system in microbiological quality control for pharmaceuticals. BCC is known for its resistance to disinfectants and is a significant contaminant in pharmaceutical products, posing risks to immunocompromised individuals. The study outlines the methodology for using Microsart® @filter with different membrane filters and media, including selective and non-selective options, to effectively detect and quantify BCC. Results indicate that selected BCC strains achieved recovery rates exceeding 80% when using the Microsart® @filter, meeting the acceptance criteria set by regulatory standards such as USP <60> and USP <61>. The findings emphasize the effectiveness of the Microsart® @filter system in ensuring microbial safety in pharmaceutical manufacturing, contributing to the overall quality control processes. This report serves as a guideline for implementing robust detection methods for BCC in various pharmaceutical applications.