The Future of QC is Now
Automation, robotics, and digitalization are leading the pharmaceutical industry to evolve towards machine-driven, continuous, and real-time-monitored manufacturing, and this pharma industry 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.
Main Benefits of Lab Automation & Digitalization
By integrating advanced technologies, Quality Control can achieve significant improvements in productivity, reliability, and data management.
- Productivity increase: Automation helps improve overall efficiency in processes, reducing the time required for repetitive tasks and allowing skilled personnel to focus on higher-value activities.
- Results reliability: Automated systems minimize the risk of human errors and cross-contamination, leading to more reliable test results.
- Data integrity and traceability: Automated data recording at each step of a test workflow enables data traceability, allowing reduction of the time spent on investigations, and ensures data integrity and regulatory compliance.
Our Commitment to Shaping the Future of QC
At Merck, we are committed to driving this transformation process. As a leading QC solutions provider, we leverage our expertise in microbiological QC and regulatory, and combine it with innovative technologies. In partnership with users and specialized engineering and robotic companies, we develop integrated lab automation and digitalization solutions for the main QC applications:
- Environmental Monitoring
- Bioburden Testing
- Sterility Testing
Our aim is to develop standardized solutions, which will make validation and life-cycle management easier. Also, thanks to our extensive range of services, we'll ensure customers receive the assistance needed before, during, and after the implementation process.
Lab Automation to Boost Reliability and Productivity
Environmental Monitoring Automation
Our goal is to automate the full environmental monitoring workflow to enhance efficiency and bring full data integrity. We are designing new solutions internally to meet customer needs for each step of the testing, but we also seize every opportunity to partner with leading-edge companies. We signed a global distribution and collaboration agreement with Rapid Micro Biosystems, Inc., which will allow us to sell the Growth Direct® system. This solution delivers faster automated results for improved decision making and business performance.
Mobile robot for automated air sampling and particle counting in classified rooms
Automate your air quality management with our cutting-edge autonomous mobile robot (AMR). Engineered to perform automated air sampling and particle counting in cleanroom environments, our solution ensures reliable measurements with minimized risks of contamination, full data traceability, and live data monitoring.
Automated EPR colony counter for environmental monitoring plates
The automated colony counter uses end‑point reading technology to count CFUs and sort EM plates with a throughput of 100 plates per hour, freeing staff to focus on higher‑value microbiology tasks.
Growth Direct® system for fully automated rapid microbial detection*
This real-time monitoring equipment automates and accelerates environmental and bioburden testing, eliminating error-prone manual processes while dramatically reducing process steps and waiting times.
*GROWTH DIRECT® is a registered trademark of Rapid Micro Biosystems, Inc.
Learn more about the Growth Direct® system
The automated bioburden testing solution enables:
- Handling of complex protocols while reducing contamination risk and false-positive-rates
- Safe and robust handling by robots thanks to robotic-friendly consumables
- Full data traceability
- Resources management improvement and allocation of skilled personnel to higher value tasks
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. This process not only guarantees compliance, but also enhances data analytics to track trends, identify deviations, and ease investigations into out-of-specification results. Digitalization alone improves lab efficiency by optimizing scheduling and reducing manual documentation and investigations. When combined with QC lab automation, it delivers even greater value and financial benefits.
The M-Trace® Software & Mobile App is your 21 CFR Part 11 compliant Digital QC companion for sterility testing!
Ensure full traceability and regulatory compliance from real-time, automatic, and complete recording of data for each of your sterility tests.
Learn more about the M-Trace® Electronic Test Record Software.
Related Resources
- Article - How Advanced Technologies are Transforming Microbial Quality Control in Pharma
This article highlights how automation and robotics are emerging not only as helpful tools, but also as strategic enablers of productivity gains, greater throughput flexibility and facilitated compliance.
Related Webinars
Explore the latest advancements in automation within fill & finish processes, with a special emphasis on the Ready-to-Use (RTU) Isobag® Auto solution.
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