Product Quality Testing
Manufacturing Quality Control
Accelerated Microbiological Quality Assurance
Rapid microbiological monitoring enables Quality Control laboratories to make product quality decisions based on timely microbiological data rather than waiting for extended culture incubation periods.
By providing quantitative insight into microbial contamination levels within hours, laboratories can strengthen contamination control programs, accelerate investigations, and support faster product disposition decisions. The result is a more responsive quality organization that maintains high standards of product safety and compliance while reducing delays associated with conventional microbiological testing.
Challenges in Product Quality Monitoring
Manufacturing Quality Control laboratories operate under increasing pressure to ensure product safety, maintain regulatory compliance, and improve operational efficiency. However, conventional microbiological methods remain heavily reliant on culture-based workflows that were developed primarily for detection rather than rapid decision-making.
As manufacturing processes become more complex and supply chains more demanding, the limitations of traditional microbiology can directly impact product release timelines, investigation efficiency, and overall quality performance.
- Culture-based methods require extended incubation periods, delaying microbiological quality assessments and product disposition decisions.
- Conventional testing methods may not adequately capture stressed or viable but non-culturable (VBNC) microorganisms, resulting in incomplete understanding of microbial contamination risks.
- Environmental, raw material, in-process, and finished product samples often generate large testing volumes that create bottlenecks within QC laboratories.
- Delayed microbiological feedback limits the ability to rapidly investigate contamination events, identify root causes, and implement corrective actions.
These limitations restrict the ability of QC teams to respond proactively to microbiological risks and often result in longer testing cycles, increased laboratory workload, and delayed quality decisions.
How We Help
Integrating Rapid Microbiology into Quality Control Workflows
The implementation of rapid microbiological monitoring is designed to complement existing Quality Control processes while providing earlier microbiological insight throughout the manufacturing lifecycle. By introducing rapid quantitative measurements at key control points, laboratories can strengthen contamination control strategies and improve the speed of quality-related decision-making.
1
Identification of Critical Quality Control Points
Testing points are selected across raw materials, in-process samples, environmental monitoring programs, water systems, and finished products based on product risk profiles and quality requirements.
2
Establishment of Microbiological Baselines
Rapid microbial measurements are used to characterize normal operating conditions and establish baseline contamination levels for products, processes, and manufacturing environments.
3
Integration into Existing QC Testing Programs
Rapid microbiological analysis is incorporated into routine laboratory workflows to provide earlier visibility into microbiological trends without disrupting established quality systems.
4
Risk-Based Decision Support and Investigation
Microbiological data is used to support contamination investigations, trend analysis, process monitoring, and quality decision-making, enabling faster response to deviations and potential quality events.
Benefits for Your Operation
Faster Quality Decisions Through Actionable Microbiological Data
In modern manufacturing environments, microbiological quality control must balance product safety, regulatory compliance, operational efficiency, and speed of decision-making. Rapid microbiological monitoring provides laboratories with timely and actionable information that enhances traditional microbiological workflows, enabling QC teams to detect risks earlier, investigate deviations faster, and support quality decisions with greater confidence.
Accelerated quality decision-making
Provides microbiological results significantly faster than conventional culture-based methods, supporting earlier product disposition and investigation activities.
Increased laboratory productivity
Reduces dependence on lengthy incubation periods and enables more efficient management of high testing volumes.
Enhanced contamination control
Improves the detection and monitoring of microbial contamination events, enabling faster implementation of corrective and preventive actions.
Advanced analytical capabilities
Expands the microbiological toolkit available to QC laboratories by providing rapid quantitative microbial data that complements traditional testing methods and strengthens quality risk assessment.
Solutions for This Application
Brief introduction explaining how the products support this application.
rqmicro.COUNT
A cartridge-based flow cytometer that rapidly quantifies total viable bacteria and specific pathogens using the rqmicro Test Kits. The instrument delivers actionable results in as little as 30 minutes. rqmicro.COUNT is designed for both laboratory and on-site use, enabling reliable microbiological monitoring.
Key Benefits
- Decentralized testing
- High-speed single-cell analysis
- Easy to use
Cloud Solution
The rqmicro Cloud Solution is a secure, browser-based platform for storing, analyzing, and sharing microbiological test results. With customizable dashboards, automated alerts, and reporting tools, it supports efficient monitoring, compliance, and data-driven decision-making across multiple sites.
Key Benefits
- Centralized Data Management
- Real-Time Monitoring & Alerts
- Simplified Reporting & Compliance
Test Kits
The rqmicro Test Kits are ready-to-use assay kits designed for rapid microbiological water analysis with rqmicro.COUNT. Available for Intact Cell Count (ICC), Legionella, and E. coli, they combine simple sample preparation with highly sensitive detection to deliver fast, reliable, and actionable results.
Key Benefits
- Rapid Results
- Reliable Detection
- Easy-to-Use Workflow
Frequently Asked Questions
Here are some common questions about the test method, instrumentation and user requirements.
rqmicro combines three core technologies in a single workflow:
- Microbiological Assays detection and quantification of microorganisms including immunoassays for the selective quantification of target bacteria.
- Microfluidic cartridge technology with integrated immunomagnetic separation (IMS) for automated sample processing.
- Flow Cytometry for rapid detection and quantification of bacteria, including viability assessment.
This integrated approach enables rapid microbiological testing without the need for lengthy cultivation steps.
Single-use cartridges provide several advantages:
- Ensure standardized workflows
- Reduce maintenance requirements
- Minimize the risk of cross-contamination
- Eliminate complex cleaning procedures
- Enable operation by non-specialist users
The cartridge-based design supports both laboratory and field applications.
The rqmicro platform is designed for the detection and quantification of total bioburden and also specific bacteria. Depending on the assay, users can analyze:
- Total viable bacteria (Intact Cell Count)
- Total bacteria (Total Cell Count)
- Legionella (L.p. SG 1, L.p. SG 1-15 and Legionella spp.)
- E. coli (incl. Big 6 and O157)
Traditional culture methods only detect microorganisms that grow on agar plates. Many bacteria can remain viable but fail to form colonies under cultivation conditions.
rqmicro uses cultivation-independent flow cytometry, allowing the detection of viable cells regardless of their ability to grow on culture media. This provides faster results and a more complete picture of microbial contamination.
Flow cytometry is a laser-based analytical method that measures individual cells suspended in a fluid stream.
As cells pass through the laser beam, fluorescent signals are generated and detected by the instrument. Thousands of cells can be analyzed every second, enabling rapid and highly sensitive microbiological testing.
rqmicro uses fluorescence-based flow cytometry together with viability staining. Fluorescent dyes interact differently with live and dead cells based on membrane integrity and physiological status.
The instrument analyzes these fluorescence patterns to distinguish viable cells from non-viable cells, providing rapid live/dead information within the measurement process.
Viability information helps users:
- Assess microbiological risk more accurately
- Evaluate treatment effectiveness
- Detect bacteria that may be missed by culture methods
- Monitor changes in water systems in near real time
This enables faster operational decisions and improved process control.
VBNC stands for Viable But Non-Culturable.
These bacteria are alive and may remain metabolically active, but they do not grow on standard culture media. As a result, conventional cultivation methods can underestimate the true microbial load.
Flow cytometry can detect these cells, allowing a more comprehensive assessment of water quality and microbiological risk.
qmicro.COUNT is designed for routine operation with minimal training.
Users do not need to be flow cytometry experts. The cartridge-based workflow and automated analysis reduce operator dependency and simplify routine testing.
Contact an Expert
Christophe Gutknecht
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