Burkholderia cepacia in pharmaceutical and healthcare settings

Burkholderia cepacia is the name for a group or “complex” of bacteria that can be found in soil and water. B. cepacia bacteria are often resistant to common antibiotics. In recent years there has been a series of product recalls involving Burkholderia cepacia complex (BCC).

To address these concerns, pharmaceutical and healthcare manufacturers establish procedures (e.g., sanitary design, equipment cleaning, environmental monitoring) to prevent contamination of non-sterile drug products.

This topic has been covered in a new book chapter, written by Tim Sandle. An abbreviated abstract is:

This chapter discusses the general characteristics of the BCC group. This is followed by a review of the potential points of origin in pharmaceutical environmet6s, which are generally low-nutrient environments like water. This is followed by a review of the potential risks to patients that the organism presents. Such risks are contextualized in relation to patient population and product type.

The reference is:

Sandle, T. (2018): Burkholderia cepacia complex: Characteristics, products risks and testing requirements. In Reber, D. and Griffin, M. (Eds.) Microbial Control and Identification, DHI/PDA books, River Grove, USA, pp197-230. ISBN Number: 9781942911272

The book is available at the PDA bookstore.



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology