Impact of Burkholderia cepacia on pharmaceuticals

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

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 use SGL Pre-poured BCSA?

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 other media such as Burkholderia cepacia agar (BCA), and Oxidation-Fermentation Polymyxin Bacitracin Lactose agar (OFPBL).

SGL supplies a wide range of other pre-poured media for use in pharmaceutical, cosmetic, clinical and veterinary applications. These include standard off the shelf media as well as bespoke media products tailored to customer specific formulations.

Representative samples of our products are QC tested in our on-site laboratory which is UKAS accredited to ISO 17025.