Rapid Sterility Testing in as little as 1-3 days with Growth Direct®

Automate your sterility testing workflow while ensuring regulatory compliance and data integrity

What Is Rapid Sterility Testing?

Traditional compendial sterility testing methods, such as USP <71>, EP 2.6.1, and JP 4.06, are manual processes that can take up to 14 days to complete, relying on subjective interpretation of microbial growth. These methods typically utilize two media types—TSB and FTM—for detection.

The Growth Direct® Rapid Sterility platform accelerates this process with digital imaging technology, detecting microbial growth in as little as 12 hours and delivering final results in just 1–3 days. Our validation approach aligns with regulatory expectations outlined in USP <1223> and Ph. Eur., ensuring robust, data-driven microbial detection. This fully automated approach reduces manual steps, enhances data integrity with electronic records, and minimizes contamination risks—ensuring faster product release and improved quality control.

Download the Growth Direct® Rapid Sterility Fact Sheet

Get all the essential details and technical specifications of the Growth Direct® Rapid Sterility System in one comprehensive document.

How Rapid Sterility Testing Compares to Compendial and Other Methods

When comparing rapid sterility testing to traditional compendial methods or semi-automated rapid solutions, Growth Direct® stands out for its speed, full automation, and a validation approach aligned with USP <1223> and Ph. Eur. 5.1.6.

The Growth Direct® Rapid Sterility System replicates all three traditional test conditions within a kit of three cassettes. Simply load the kit, and our automated closed-loop system does the rest—running as many as 126 samples at once while reducing the risk of secondary contamination. As the only fully automated, non-destructive platform for rapid sterility testing, it enables immediate investigation in the event of a positive result, with organisms accessible directly from the cassette—eliminating the need for additional subcultivation or transfer for identification.

Compendial Methods (1)

Test Smarter. Release Faster

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Key Benefits of Automated Rapid Sterility Testing with Growth Direct®

Fast, Accurate Results

Automate traditional processes to reduce hands-on labor and minimize human error—while real-time contamination alerts enable faster responses to potential risks, helping protect product quality and ensure consistent, reliable results.

Faster ID, No Transfers

Microorganisms remain viable and directly accessible within the cassette, eliminating the need for subcultivation. This enables immediate identification and faster root cause investigations in the event of a positive result.

Reduced Human Error

Automate traditional processes to significantly reduce the risk of human errorand need for hands on labor,increasing consistency and reliability across all tests.

Enhanced Data Integrity

Automates handling and data capture to minimize errors and enhance consistency. Real-time electronic records provide traceability, audit readiness, and support validation aligned with USP <1223> and Ph. Eur. 5.1.6. Seamlessly integrates with all major LIMS platforms.

Rapid Sterility Media

Use a single, optimized growth medium—Rapid Sterility Media—that supports the growth of organisms across multiple testing conditions, streamlining the testing process. No other costly reagents needed.

Closed-Loop Design for Test Integrity

A closed-loop design prevents contamination, while non-destructive detection reduces false positives for reliable, accurate results.

Learn more about The Benefits of Rapid Sterility Testing.

Business Case: Measurable Impact from Faster Sterility Testing

The Growth Direct® Rapid Sterility System delivers sterility test results in 1–3 days, compared to traditional methods that can take up to 14 days. This speed enables:

Reduced manual labor by up to 85%, lowering the workload for lab technicians and minimizing human error.
Decreased investigation costs by approximately $75,000 per year due to faster identification and resolution of sterility issues.
Lower holding costs estimated at $900,000 annually by shortening product quarantine time.
Increased throughput capacity, allowing more samples to be processed in less time without additional staffing.

These efficiencies contribute to an estimated acceleration of revenue recognition by $10M–$15M and labor cost savings of around $160,000 annually. Based on these figures, organizations can expect a return on investment within 12 to 18 months.*

For detailed data and analysis, see the Fast Track Sterility Infographic.

*Example provided for illustrative purposes only. Actual results and impact will differ depending on specific customer circumstances.

How does the Growth Direct® Rapid Sterility System work

Growth Direct® integrates into your existing aseptic isolator or biosafety cabinet (BSC), allowing labs to transition from manual sterility testing to a validated, automated workflow with minimal disruption.

Here's how it works:

Pre-Rinse

Rinse the filtration device with a sterile solution to eliminate any residual disinfectants and prepare the system for sample introduction.

Add Sample

Introduce the product sample into the filtration unit aseptically, following your standard handling procedures.

Rinse

Perform a secondary rinse to ensure complete sample delivery and remove any residuals that could impact growth detection.

Add Media

Add Growth Direct® proprietary sterility testing media into the cassette. No reagents are needed, reducing consumables and simplifying preparation.

Remove & Activate

Seal the cassette and activate it for processing. This action prepares the system for automated incubation and microbial growth detection.

Insert the sealed and activated cassette into the Growth Direct® Rapid Sterility System. From here, the system takes over—automating incubation, detection, and result reporting.
That’s it—once the cassette is loaded, the rest is fully automated. No manual intervention, no additional steps. Just fast, reliable results.

Regulatory Acceptance of the Growth Direct® Rapid Sterility System

The Growth Direct® Rapid Sterility System is engineered to align with global regulatory guidance:

USP <1223>: Supports the validation of alternative microbiological methods
Ph. Eur. 5.1.6: Endorses the use of rapid microbiological technologies
21 CFR Part 11: Enables compliant digital records and audit trails

Design verification and beta testing confirm the system’s readiness for validated GMP workflows, ensuring reliability and regulatory confidence.

Additionally, the system upholds best practices outlined in USP <1117> for microbiological laboratory operations—minimizing human error, improving aseptic handling, and enhancing documentation consistency.

Explore: Regulatory Considerations for Rapid Sterility Testing

Implementation Simplified: Growth Direct® Fits Right Into Your Workflow

Is It Difficult to Implement?

The Growth Direct® Rapid Sterility System is designed for easy integration into your current sterility testing setup. It works seamlessly within your existing isolator or biosafety cabinet (BSC) with minimal adjustments. The system automates key steps like incubation, detection, and result reporting, simplifying the process and reducing manual handling. Although there’s an initial setup and validation process, the system is user-friendly, and our team is here to guide you through each step to ensure a smooth transition.

What Support Can Clients Expect?

When adopting the Growth Direct® system, you get comprehensive support throughout the process:

Onboarding & Training: Customized training tailored to your team’s specific needs.
Validation Assistance: Guidance in developing your validation protocol and conducting parallel testing.
Ongoing Technical Support: Access to expert support for troubleshooting, maintenance, and system updates.
Regulatory Compliance: Help ensuring your system meets global standards like USP <1223> and 21 CFR Part 11.
System Integration: Seamless integration with your existing LIMS for efficient data management and reporting.

Want a deeper dive into the process? Check out our blog 5 Steps to Implement Rapid Sterility Testing for best practices and implementation insights.

Have Questions About Cost or Implementation? Let’s Talk.

Interested in how Growth Direct® Rapid Sterility fits into your lab—and your budget?
Our specialists are here to walk you through the ROI, implementation process, and answer any questions you may have.

Curious about the ROI? Discover the business case for implementing Growth Direct® Rapid Sterility.

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GROWTH DIRECT BROCHURE

Rapid Sterility Testing in as little as 1-3 days with Growth Direct®

What Is Rapid Sterility Testing?

How Rapid Sterility Testing Compares to Compendial and Other Methods

Test Smarter. Release Faster