Burkholderia cepacia complex (BCC) is one of the most common bacterial species found in healthcare-associate products, especially in relation to contamination of aqueous inhalers and some intravenously administered products. Creative BioMart Microbe offers BCC testing service for accelerating your products development processed.
Burkholderia Cepacia Complex (BCC)
The BCC is a group of 17 bacteria species that are phylogenetically differentiated, but indistinguishable phenotypically. These bacteria species are Gram-negative, rod-shaped and capable of growth in a variety of environments including soil, water, animals, and plants. These bacteria can survive for months in harsh conditions and can be spread through skin-to-skin contact or through sweat. Importantly, several species demonstrate antibiotic and alcohol based resistances, which make it a formidable microorganism to eliminate.
The BCC organisms are typically identified as a plant and human pathogen. For plants, they are known to cause onion bulb rot. For human, they are opportunistic pathogens and can pose serious medical risks to the immune system compromised patient populations, mechanically ventilated patients, and those suffering from underlying diseases (especially cystic fibrosis).
In 2017, FDA issued a public notice, advising drug manufacturers of the health risk posed by Burkholderia cepacia contaminated products. The United States Pharmacopeia has created guidelines for BCC testing in order to ensure the absence of BCC in regulated products. USP <60> specifies the test strains for growth promotion, suitability methods and selective media needed.
Methods for BCC testing offered by Creative BioMart Microbe:
- Broth microdilution
- Agar dilution
- Gradient strip
- Disk diffusion
- USP method
The following products could be detected by BCC testing:
- Raw material and additive
- Tools and production equipment
- Production and storage environment
- Packaging material
- Final products
- Others…
Creative BioMart Microbe provides BCC testing service with following advantages:
- Multiple testing methods.
- Reliability and available analysis.
- Customized services to meet specific needs.
- Competitive price on market.
Workflow of BCC Testing Service at Creative BioMart Microbe
Creative BioMart Microbe is working to validate test methods for healthcare-associate products. We promise to work closely with customers, please feel free to contact us for more information.
References:
- Ali M. Burkholderia Cepacia in Pharmaceutical Industries. Int J Vaccines Vaccin. 2016, 3(2): 00064.
- USP <60> Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacian Complex.
- Wootton, M., et al. Evaluation of susceptibility testing methods for Burkholderia cepacia complex: a comparison of broth microdilution, agar dilution, gradient strip and EUCAST disk diffusion. Clinical Microbiology and Infection. 2020.
