Primary validation study of a new generation of solid phase cytometer for rapid sterility testing of pharmaceutical products.

Ensuring the sterility of pharmaceutical products, particularly those administered parenterally, is crucial for patient safety. Conventional sterility testing methods, while reliable, require incubation periods of up to 14 days, delaying product release. Therefore, exploring alternative rapid microbiological methods is essential for improving testing efficiency and reducing the time-to-result (TTR). This study evaluates the Red One™ system, a novel rapid method utilizing solid-phase cytometry and esterase-based activity staining, which reduces the TTR to just 96 h. Our results demonstrate the non-inferiority of the Red One™ system compared to traditional culture-based techniques by assessing key performance parameters, including limit of detection, accuracy, robustness, and ruggedness for various microorganisms, including slow-growing species such as Cutibacterium acnes. Our results indicate that this alternative system is an effective method for rapid sterility testing in the pharmaceutical industry.