An Emerging Challenge for Liquids Manufacturers
Burkholderia cepacia (pronounced burr-kuld-AIR-eeyah see-PAY-sheeyah) is not like your E. colis and Salmonellas of the world. Few people outside of healthcare settings have ever heard of this bacterium, and that’s why we’re here. We want to fill in some gaps for this emerging pathogen that is often overlooked when designing product testing protocols and specifications.
We’ll start with some recent history. There were two major multi-state outbreaks of Burkholderia cepacia complex in 2016 and 2017 that were traced back to liquid docusate, a medication used both in healthcare settings and home environments. The FDA issued product recalls following these outbreaks and this put drug manufacturers on notice: comprehensive microbiological testing is non-negotiable. While Daane Labs is not yet in the drug-testing game, we have seen increasing interest in Burkholderia cepacia testing among medical device manufacturers, personal care product manufacturers, and even some bottled water companies. Since no standard laboratory protocol existed for detecting this organism in non-drug substances, Daane Labs actually developed and validated our own, proprietary method to detect the presence of B. cepacia in customer samples. It’s something we are very proud of.
Alright, enough tooting our own horn and moving on… We can’t let a whole blogpost about Burkholderia cepacia slip by without diving into the actual bacterium itself. Science nerds, this is for you! Burkholderia cepacia is a non-fermentative Gram-negative bacilli that behaves as an opportunistic pathogen. It is multi-drug resistant, gamma-hemolytic, and mesophilic with an incubation time of 2-3 days. B. cepacia has extraordinary metabolic capabilities – it can reproduce in distilled water, for example. This bacterium was grouped with Pseudomonas species as Pseudomonas cepacia until 1981 because of their many shared morphological and biochemical characteristics. Once genomic sequencing became more widely-used, many Pseudomonas species were transferred to the novel Burkholderia genus.
We’ll preface this conclusion by saying that Daane Labs isn’t in the business of telling you how you should test your product. You know your product and manufacturing process better than we do, so you really are the best person for that job. What we want to stress here is that microbial testing often goes beyond a simple Yeast & Mold count or a E. coli screen. Sometimes your product or process is unique enough that you might have to think outside the box and test beyond the typical indicator organisms. Maybe that means you look into testing your products for B. cepacia, or maybe it means you give consideration to some other facet of your operation.