Building the Business Case for the Growth Direct® Rapid Sterility System
Making the case for rapid sterility testing can feel like an uphill battle. While many sterility labs may already understand the benefits of rapid microbiological methods (RMMs)—from faster results, to improved workflow efficiency—navigating the initial investment and internal buy-in required to implement even the most compelling system can seem like a big step.
That’s where this blog—and your team at Rapid Micro Biosystems—comes in.
We’re here to help you build a clear business case for the Growth Direct® Rapid Sterility System (GDRS), focusing on where the return on investment (ROI) really comes from: tangible savings like faster batch release, lower labor costs and fewer investigations.
At the heart of this shift are two performance metrics that matter most to manufacturing timelines:
| Performance Criteria | Description |
| Time-to-Detect (TTD) | The time it takes to first detect microbial growth, the first indication of contamination. |
| Time-to-Result (TTR) | The time it takes to confirm that no additional microbial growth will occur, indicating a final sterility test result. |
In this blog, we’ll show you how to turn those performance gains into savings—we’ll walk you through the key drivers of ROI and give you the tools to convince stakeholders that now is the time to make the switch.
Explore the regulatory implications of adopting RMM sterility testing
Faster batch release = More batches, more revenue
Challenge: Compendial sterility testing methods are reliable, but their lengthy incubation times—sometimes taking up to 14 days—can slow down batch release and create inefficiencies in production.
Solution: Rapid sterility testing with GDRS significantly reduces the Time-to-Detection (TTD) and TTR, delivering sterility test outcomes in as little as 1–3 days.
Impact: With faster results, manufacturers can release batches sooner, allowing for greater annual production capacity and higher throughput. Shorter batch hold times also bring lower storage costs, faster revenue recognition, and most importantly, reduced patient wait times.
Reduced labor costs and optimized workflow
Challenge: Manual sterility testing demands significant technician hands-on time. These labor-intensive processes not only introduce variability and potential errors but also limit the ability to scale production efficiently.
Solution: GDRS automates the entire workflow, eliminating unnecessary manual intervention and allowing microbiology teams to focus on higher-value activities.
Impact: With the system capable of handling up to 126 tests simultaneously, labs can process more samples without increasing staff numbers. This lowers direct labor costs while improving employee productivity.
Learn how Rapid Micro Biosystems helps you implement and validate GDRS in 5 simple steps!
Faster investigations and reduced downtime
Challenge: Sterility failures can halt production, triggering lengthy investigations that keep batches in quarantine and delay market release. Every day spent resolving an investigation translates to mounting storage costs and revenue losses.
Solution: With GDRS, the TTD is as fast as 12 hours, enabling teams to identify potential contamination events far earlier than with traditional methods.
Impact: By accelerating root cause analysis, GDRS helps manufacturers resolve sterility investigations faster, keeping production schedules on track and preventing unnecessary quarantines.
Lower investigation risk and build greater confidence in test results
Challenge: Investigations into sterility failures can be costly and complex, especially when secondary contamination or false positives contribute to inconclusive findings. Traditional methods leave room for environmental exposure, increasing the chance of false results that require further testing.
Solution: GDRS mitigates this risk with its fully automated, closed-loop system, ensuring minimal handling and precise detection.
Impact: By reducing contamination risks, manufacturers can trust that their rapid sterility test results reflect real microbial presence rather than external interference. This enhanced reliability prevents unnecessary investigations, saving time, reducing costs and maintaining production momentum.
How to calculate your ROI with GDRS
Investing in GDRS isn’t just about upgrading technology, it’s about unlocking measurable financial and operational benefits.
Here’s how to calculate your potential savings:
1.Compare direct operational costs
3. Account for investigation savings
GDRS delivers a faster, more efficient and cost-effective approach to sterility testing—helping manufacturers reduce costs, optimize workflows and increase revenue potential. If you’re considering the switch to rapid sterility testing, Rapid Micro Biosystems can support you every step of the way. Our team works directly with customers using a dedicated ROI calculation tool to help quantify the value GDRS can deliver in your specific sterile manufacturing space.
From identifying savings to building a clear, data-driven business case, we’ll help you demonstrate your potential ROI and gain the internal support you need to move forward with confidence.
Contact us today to calculate your ROI and see how GDRS can transform your sterility testing process