New Release Automates Microbial QC Process for Pharmaceutical Manufacturers

Rapid Micro Biosystems, a company developing innovative products for faster and automated detection of microbial contamination, have announced the availability of Service Pack 2 software for the Growth Direct™ System.

The new release includes both user and industry driven product features that enable Quality Control labs to improve their performance by optimizing workflow and eliminating waste. These capabilities will drive the transformation from manual quality control to an automated, paperless laboratory.

Increased Manufacturing Efficiency and Throughput
New alerting features let the business respond faster to key quality events, such as the early warning of contaminated product samples, improving efficiency, speeding corrective actions and preventing product loss. Other alerts ensure testing compliance, such as indicating when samples have not been properly handled. Escalation emails trigger samples that exceed an action or alert limit. Device alarms sound when quality anomalies occur.
Early notification of contamination allows the QC lab to take action earlier and prevent further product corruption. For example, taking a fermentor offline before its material is combined with other product in-process enables more productive use of plant resources and capacity. Continuous readout of microbial results prior to completion allows users to get an early view of any developing contamination issues and consult proactively with their manufacturing partners to resolve it.

Electronic access to testing results through a company's Laboratory Information Management System (LIMS) allows key stakeholders beyond the QC lab to view testing results as they are completed, eliminating unnecessary emails, meetings, phone calls and paper. These stakeholders can then take faster remediation based upon sample results, improving their efficiency and focusing on process improvements.

Automating the Quality Control Laboratory
Service Pack 2 focuses on features to streamline workflow and eliminate waste in the QC lab. These new Growth Direct™ System capabilities allow pharmaceutical companies to efficiently manage their labor resources and changes in workload. For instance, users can increase laboratory testing efficiency through batch loading of samples while providing flexibility to accommodate random access sample loading.

The paperless QC lab is enabled through seamless LIMS connectivity that automates results recording, data management and reporting, a common source of errors. The system automatically archives results and history, integral to regulatory compliance and critical for traceability and audit-ability.

Custom reporting allows users to tailor reports specific to their needs. Users can easily and efficiently adjust reports to match the laboratory convention and business needs. The time saved allows the quality lab to improve efficiency, reduce errors and focus on value-added activities, critical to any Lean Laboratory program.

Rapid Micro Biosystems CEO, Steve Delity says, 'Poor productivity in the Pharmaceutical industry is a significant problem. This is costing organizations millions of dollars a year that, when fixed, drop straight to the bottom line. Our enhancements to the Growth Direct™ System help companies compete in a tough global market by automating and modernizing their quality processes and detecting microbes in half the time of traditional methods. This improves manufacturing cycle-time, increases production capacity and productivity to drive quantifiable results.'