The Burkholderia cepacia complex (B. cepacia or Bcc) is a group bacterial species that are becoming an increasing concern for personal care product manufacturers. Species belonging to the Bcc are opportunistic pathogens that have caused consumer illnesses and product recalls. Regulatory bodies such as the FDA has issued numerous recalls for products that contaminated with Bcc. Water-based products that have been notably affected by Bcc-related recalls, include sanitisers, mouthwashes, skin creams, wipes, and baby products. It is critical that we expand our understanding of these microorganisms, their impact, and the importance of microbiological controls in the manufacturing process.
Bcc is especially troublesome because of its abilities to resist preservatives and grow in unfavourable environments. One Bcc species, Burkholderia multivorans, can grow well in low-nutrient environments such as distilled water and can form biofilms. Recently, the FDA found B. multivorans was detected in preserved nasal spray prior to release. Two batches of the spray were discovered to be contaminated during microbial testing. Additional lots contained Bcc as well, though they previously had tested negative. The manufacturer established that bacterial growth was initially inhibited by the preservative but then overcame it and flourished. Detailed testing identified the exact Bcc species responsible for the contamination was B. multivorans.
Species level identification allowed the manufacturer to link the batch contaminations and perform a high-quality internal investigation to find the contamination source. Ultimately, the organism was traced to the purified water system and having established root cause, the manufacturer was able to correct the plumbing and implement additional corrective and preventative actions.
Catching microbes, like B. multivorans, before they become a problem and working to implement a microbial contamination control strategy means monitoring your environment with updated technology to catch microbial contamination faster and more accurately.
