burkholderia cepacia usp

What is Burkholderia cepacia? It is an opportunistic pathogen that has the ability to remain viable under harsh conditions as it is resistant to certain preservatives and antimicrobial agents.


Burkholderia cepacia [burk-hōld–er–ee-uh si–pay–shee–uh] (also called B. cepacia) is the name for a group or “complex” of bacteria that can be found in soil and water.
2011, 65 (5), 535–543.

Bcc are gram negative aerobic bacteria found in soil and water.

2019 New General Chapter USP <60> Tests for Burkholderia Cepacia Complex, 15th January 2020.

A frequent reason for recalls of nonsterile products is contamination with Burkholderia cepacia , a microorganism capable of causing serious illness in patients with impaired immune systems or chronic lung disease.

Although commonly found in natural environments such as the soil, water, and plants, B. cepacia can infiltrate pharmaceutical manufacturing environments and contaminate raw materials and finished drug product. The United States Pharmacopeia (USP) has proposed a new chapter to address one of the most prevalent microbiological threats in the pharmaceutical and healthcare industries. Technol. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and … 1993 Type species ATCC 25416 CCUG 12691 and 13226 CFBP 2227 CIP 80.24 DSM 7288 HAMBI … Diagnosing B. Cepacia. B. cepacia, Burkholderia cepacia complex, nonsterile pharmaceutical, USP To test, or not to test – that is the question.

In the 2001 Pharmacopeial Forum the USP proposed a procedure for the isolation of B. cepacia from non-sterile products as part of the overall harmonization of the Microbial Limit Test chapters. 3 This article has signalled this forthcoming change and the usefulness of the forthcoming test method for microbiologists tasked with testing water systems and products that are at risk from BCC organisms. Diagnosing B. Cepacia. Presenter, Luis Jimenez, will also discuss technology, the optimization of …

This looks set to change with the proposed USP Chapter 60 “Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex”. Testing for BCC was developed due to numerous adverse events reported, especially in aqueous product where BCC may be associated with manufacturing water systems.

The Waiting Is Over – A New General Chapter, USP 60>, Burkholderia cepacia Is On The Horizon. We are excited to present and sponsor an upcoming free webinar opportunity with American Pharmaceutical Review to explore Burkholderia cepacia complex (Bcc) contamination in pharmaceutical products, the new USP <60> on Bcc, and recent FDA recall data for objectionable microorganisms. The Burkholderia cepacia complex (Bcc) is a group of 17 closely related bacteria species.

2019 New General Chapter USP <60> Tests for Burkholderia Cepacia Complex, 29th January 2020: 29 Jan 2020 . B. cepacia, Burkholderia cepacia complex, nonsterile pharmaceutical, USP To test, or not to test – that is the question. USP <60> may be utilized to determine the microbial quality of NSDS, …

Contact

 

LINE Contact