Biopharmaceutical manufacturing is advancing towards unprecedented improvements in speed and capacity. To keep pace, new strategies for Quality Control (QC) are needed.
Traditional microbial Quality Control (QC) test methods are slow to yield results, labor-intensive, prone to human error, vulnerable to tampering, and are incompatible with the need to accelerate manufacturing workflows. Delayed issue identification and resolution can slow deployment of therapeutics to patients, while issues with data integrity can severely impact the bottom line and corporate reputation.
The high-throughput, high-capacity Growth Direct Platform effectively replaces the time- and labor-intensive manual approach. Test results are available in dramatically less time, enabling faster product release, greater capacity, and enhanced data integrity and security.
This Rapid Microbial Method (RMM) employs digital imaging technology combined with sophisticated software algorithms to detect and count the autofluorescence of growing microbes to ensures accuracy and consistency, ideal for environmental monitoring, water testing, and bioburden testing.
This innovative RMM enables labs to achieve greater efficiencies with minimal human handling:
Incubation
The Growth Direct™ System software converts each sample into a digital record via a unique QR Code that tracks the sample through the full chain of custody. Robotic arms automate transfer processes.
Detection
Autofluorescence lighting, proven to provide the best detection capabilities, is able to spot contamination at the micro-colony stage of development.
Enumeration
With detection data from the autofluorescence technology, the system software uses proprietary algorithms for accurate colony counting.
Transcription
The software’s robust data integration capabilities seamlessly connect results from Incubation, detection and enumeration to allow for more rapid results.
Connectivity options can bring system performance to the next level:
Remote Monitoring and Reporting Enable Manufacturing Continuity
Remote system monitoring and data reporting capabilities can ensure manufacturing continuity at a time when QC labs must remain fully operational, despite reduced staff due to unforeseen events such as COVID-19 restrictions.
An innovative and secure web-based application, the Remote Monitoring System (RMS) relieves lab staff from retrieving and uploading data. In the event of an operational issue, Rapid Micro System’s support team can immediately access log files to pinpoint the problem for quick corrective action. Log file data also can be used to analyze machine performance, enabling predictive maintenance to maximize system uptime
Network Connectivity Delivers Seamless LIMS Integration
The Growth Direct Platform can operate as a standalone rapid microbial test or be integrated into a LIMS. Digitization of test results eliminates the possibility of manual transcription errors or data tampering. Data can be directed to different LIMS and other networked programs (e.g., environmental monitoring trending databases). System software creates a standard export file in .csv format that can be parsed by the networked program to pull relevant data.
Email Connectivity Promotes Rapid Response
Email alerts can be sent to different personnel according to the data set. The QC lab manager can be alerted for Out Of Specification (OOS) sample results, the facilities manager for incubator temperature excursions, and the Rapid Micro Biosystems service team for system service issues for quick corrective action.
Innovative Technology >
Ensures data integrity >
Increases efficiency >
Effective risk management >
Streamlines quality programs >
