Burkholderia Cepacia Selective Agar (BCSA), USP

Testing for Burkholderia cepacia in a Pharmaceutical setting?

SGL is excited to introduce a pre-poured Burkholderia cepacia Selective Agar (BCSA) in 90mm plate format, a selective growth medium specifically designed to meet the formulation requirements listed in USP <60> to recover Burkholderia cepacia, a bacterial species of rising importance in the pharmaceutical, clinical and cosmetic industries in recent years.

Burkholderia cepacia is a member of a group of more than 20 closely related species in the Burkholderia cepacia complex (BCC). BCC strains are some of the most versatile Gram-negative bacteria with a wide environmental distribution in soil, plants, and water.

Impact of Burkholderia cepacia on pharmaceuticals

These traits constitute the reason that BCC is one of the contaminants most frequently encountered in sterile and non-sterile pharmaceutical products.

Health–care associated outbreak of BCC have been linked to contaminated nebulized and intravenous solution, including commercial distributed products, skin care product and disinfectant.

In the past decade, organisms that fall within the BCC grouping have been identified as potentially ‘objectionable’ within the pharmaceutical manufacturing environment (7).

Testing for Burkholderia cepacia

Until recently there was no compendial testing procedure detecting BCC in pharmaceutical components or finished product. On December 1, 2019 The United States Pharmacopoeia (USP) published chapter <60> Microbiological Examination of Non-sterile Products – Tests for BCC. The USP <60> specifies the test strains for growth promotion, suitability methods and selective media recommended to ensure the absence of BCC.

With the creation of the USP<60>, the pharmaceutical industry has taken a definitive step towards addressing the public health risks posed by B. cepacia.

Why Choose SGL Burkholderia cepacia Selective Agar (BCSA)?

-Meets the USP formulation criteria

-Quicker and better isolation of BCC

-Increased selectivity

-Fewer false positive

SGL BCSA pre-prepared media contains numerous nutritional components, and energy sources that support BCC growth, and a mixture of antibiotics designed to prevent the growth of non-fermenters not belonging to the BCC and typical environmental isolates such as Pseudomonas and Staphylococcus species.

This allows for easier detection of BCC in test samples containing background contaminants.

All these elements make BCSA more selective and efficient in growing BCC colonies than the other media such as Burkholderia cepacia agar (BCA), and Oxidation-Fermentation Polymyxin Bacitracin Lactose agar (OFPBL).