By leveraging single-cell detection, Red One™ delivers faster results compared to traditional microbiology methods, enabling quicker confirmation of pharmaceutical product quality and expedited product release.
How Does It Work?
Red One™, based on cutting-edge Solid Phase Cytometry technology, utilizes advanced image processing to detect viable cells by monitoring the assimilation of staining agents through enzymatic labeling. With its 10-minute real-time fluorescence analysis, it offers highly reliable differentiation of viable cells from inert particles, achieving unmatched sensitivity and speed. Red One™ operates with a high level of automation, eliminating the need for human interpretation, thereby enhancing analysis repeatability and robustness.
Versatile Applications Across Pharmaceuticals and Healthcare
Red One™ is compatible with a broad spectrum of filtrable samples found within the pharmaceutical, biotech, and personal care industries, including raw materials, in-process water (such as purified water and WFI), sterile final products (including biological matrices, radiopharmaceuticals and traditional drugs), non-sterile final products (especially aqueous preparations), and cell-based products, including cell and gene therapies (after pre-treatment.
Bioburden testing is a pivotal quality control step for contamination detection, in accordance with Ph. Eu. 2.6.12 and USP <62> guidelines. Traditional compendial methods rely on microbial growth, which may not align with manufacturers' demands for swifter operations. Red One™ offers a rapid detection solution based on the activation of total aerobic flora, providing both speed and accuracy.
All three bioburden testing applications follow the same streamlined 3-step workflow shown in this video:
Three distinct applications are available:
BB – Bacteria Including Spores: Enumeration of aerobic total bacterial flora, Time-to-Result (TTR) = 3 hours, Quantitative result - Limit Of Quantification (LOQ) = 5 viable cells per tested sample
BB – Bacteria Fungi: Enumeration of aerobic total mesophilic flora Time-to-Result (TTR) = 4 hours Quantitative result - LOQ= 5 viable cells per tested sample
BB – 0 CFU: Presence/absence assay, with a 24-hour enrichment phase, allowing sufficient growth to detect the presence of even very low inoculum. Time-to-Result (TTR) = 24 hours Qualitative result - Limit of Detection (LOD) = 1 viable cell per tested sample Ideal for situations where 0 CFU is expected, such as for bulk drug substances release.
The three-step workflow involves:- Filtration of both sample and activation/enrichment buffer
- Activation/enrichment phase (3 to 24h incubation)
- Automated analysis on Red One™
Accelerated Sterility Release Testing in 4 Days
Compendial sterility testing takes 14 days for a final result, as per pharmaceutical industry standards (Ph. Eu. 2.6.1 and USP <71>). Red One accelerates this timeline to achieve results in just 4 days while keeping the standard sample preparation protocol (and the possibility of post-identification) thanks to its 2-step sterility testing :
Step 1. Enrichment phase in compendial liquid media (TSB & FTM)
- Filtrable products: strictly based on sample preparation in standard double-canister device
- Non-filtrable products: direct inoculation in bottles
- Incubation: 4 days for LOD= 1 CFU (Ph. Eur. 2.6.1) or 24h for LOD < 100 CFU (Ph. Eur. 2.6.27)
Step 2. Analysis performed on Red One™
- Sampling 1mL from each canister
- Dropping onto a Red Cap
- Analysis on Red One™: 10 minutes per Red Cap
- For cellular matrices, a cell separation step based on a selective lysis is applied before the analysis
No need to change your sample preparation - Red One™ offers a quicker read-out than any other method.
In Summary
Stay Compliant and Informed
Red One™ software suite complies with 21 CFR part 11 requirements, ensuring data integrity and regulatory compliance. The Redberry team provides comprehensive support for equipment roll-out in GMP environments.
Join us at the Pharmalab Congress to witness the presentation of preliminary validation results for rapid sterility testing!
Find out more , or use the green "Request Information" button below to ask for details.
