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Building the Smart Laboratory of the Future
Automation, robotics, and digitalization are leading the pharmaceutical industry to evolve towards machine-driven, continuous, and real-time-monitored manufacturing, and this Pharma 4.0 transformation process is reaching microbiological quality control labs. Traditionally involving a high level of repetitive manual tasks, microbial QC is set to make big strides in productivity, data integrity, and reliability by fully automating test handling and data management.
We at Merck committed to driving this transformation process. In partnerships with specialized engineering and robotic companies we are combining the best of our technologies to jointly develop integrated lab automation solutions in several areas, including:
- Air and surface sampling in clean rooms and isolators (environmental monitoring)
- Media plate incubation with automated colony enumeration
- Fully automated bioburden testing solutions
- Automatic, real-time data capturing for applications like sterility testing
In the course of our laboratory robotics and automation partnerships we are adapting and enhancing our proven microbiology laboratory equipment to make it compatible with QC automation.
Lab Automation to Boost Reliability and Productivity
Automating repetitive, labor-intensive tasks frees up lab technician time for higher value tasks. Laboratory robotics and automation systems operate tirelessly and with precision, and their standardized motions are repeatable. This reduces handling errors and cross-contamination, thus improving the robustness of the test as the risk of false positives and subsequent deviations decreases. Investigation times and costs are lowered and fewer batches lost, ultimately boosting productivity.
Lab Digitalization as an Amplifier of Efficiency Gains
Automated data recording at each step of a test’s workflow, from selecting stored materials to sample collection, testing, incubation, and result reporting, guarantees full data integrity and traceability. On top of ensuring compliance this enhances data analytics to track trends, spot deviations, and ease investigations into out-of-specification results. Digitalization alone improves lab efficiency by optimizing scheduling and reducing manual documentation and investigations. In conjunction with QC lab automation, it delivers even greater value and cost savings.
Customer Participation in Development
To better understand customers’ specific challenges, constraints, and needs, a user advisory group (UAG) of QC professionals at leading pharmaceutical companies supports us with feedback on the laboratory automation solutions we develop. We invite them to inspect our prototypes and discuss with us where they see the need for improvements. After implementing changes, we invite them once again to review. This iterative process helps us to refine our QC automation solutions.
Microbial Quality Control Workflow
Bioburden Testing
Sterility Testing
Environmental Monitoring
Automated Data Integrity in Sterility Testing
Today, QC microbiological testing is operator-dependent and involves manual processing of samples and recording data. This process is time-consuming and can impede the test results. We offer a sustainable solution for microbial QC testing that is fully automated and digitalized – the data is captured and evaluated in real-time to ensure faster release of products and quicker corrective actions to maintain compliance.
Watch the webinar and learn from our expert the benefits of workflow automation in microbial QC testing and how M-Trace™ electronic test record software can facilitate automatic and real-time data management with full traceability and compliance for your sterility testing and other regulated processes.
Learn more about M-Trace™ electronic test record software.
Related Product Resources
- Pharmaceutical QC Lab Automation and Digitalization Partnerships
- Webinar: Robotics & Automation: Anticipating and Implementing Laboratory Transformation, with its Opportunities and Challenges
Explore optimized solutions for the automation of microbiology QC and learn more about the benefits of automating a test workflow.
- Whitepaper: Robotics & automation on the brink of transforming pharma QC
We are partnering with pharmaceutical companies to automate the microbiological QC testing processes. By enhancing lab digitalization, we aim to minimize the risk posed by human errors and lower costs.
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