Quantitative determination of microbial contamination for pharmaceutical drug products, medical devices, and raw materials. We design enumeration programs that recover organisms reliably, satisfy method suitability requirements, and generate data that holds up under regulatory scrutiny.
Microbial enumeration and specified organism testing is foundational to product safety and release, but the methods don’t always cooperate. Inhibitory formulations, antimicrobial preservatives, complex matrices, and low sample volumes can all compromise recovery and produce results that are technically compliant but scientifically questionable.
We approach bioburden enumeration as a method design problem, not just a testing service. Before any sample is plated, we evaluate the product matrix, assess potential for inhibition, and select or develop an approach that actually recovers organisms under realistic conditions. That groundwork is what makes the data defensible.
