Burkholderia cepacia Contamination of Pharmaceutical Products and compliance with USP <60>

Previously Aired Live on February 13, 2020

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Overview

Join Dr. Luis Jimenez as he discusses current research and FDA recall information of Burkholderia cepacia complex (Bcc) contamination in the pharmaceutical industry. Microbial contamination of drugs remains a threat to public health in the United States. Pathogenic microorganisms cause morbidity and in some cases mortality when present in pharmaceutical samples or processes.

Burkholderia cepacia complex remains the number one objectionable microorganism in the United States. Recent FDA recall data from 2012 to 2019 will be presented, and outbreaks caused by Bcc contamination. We will analyze Bcc unique metabolic and genetic diversity promoting the survival and growth of Bcc in drugs and processes when operators do not perform proper validation and system design.

Technologies and the optimization of manufacturing and QC of pharmaceutical drugs, which will provide proper process control and eliminate the risk of having Bcc microorganisms in products will be presented.

Kali Sorum, Technical Support Supervisor at Microbiologics, will address the recent USP chapter, <60>, guidance for Bcc isolation, selective media, growth promotion, and suitability studies.

Presenters

Mike Auerbach

(Moderator)
Editor-in-Chief,
American Pharmaceutical Review

Dr. Luis Jimenez

(Presenter)
Associate Professor of Microbiology
Bergen Community College
View Biography

Kali Sorum

Technical Marketing Manager
Microbiologics
View Biography