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Faster QC Decisions
 
 

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

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Sterility Validation, Simplified
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Fast Track Sterility Testing
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ON-DEMAND WEBINAR
Evaluating Growth Direct® for Microorganism Detection
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5 Steps to Implement Rapid Sterility Testing
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The Benefits of Rapid Sterility Testing
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ON-DEMAND WEBINAR
Using Alternative Medium in Rapid Sterility Testing
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Pharmaceutical Sterility Testing
MODERNIZING MICROBIAL QC

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.

Growth Direct system used for rapid sterility testing in GMP facility
PERFORMANCE AT A CLANCE

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.

How Rapid Sterility Testing Compares to Compendial and Other Methods
SEE THE NUMBERS

Test Smarter. Release Faster.

See how Growth Direct® accelerates sterility testing, cuts costs, and reduces errors — all in one quick visual.

Download the Infographic
WHY IT WORKS

Key Benefits of Automated Rapid Sterility Testing with Growth Direct®

Growth Direct system used for rapid sterility testing in GMP facility
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.
Growth Direct system used for rapid sterility testing in GMP facility
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.
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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.
Growth Direct system used for rapid sterility testing in GMP facility
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.
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Reduced Human Error
Automate traditional processes to significantly reduce the risk of human error and need for hands on labor, increasing consistency and reliability across all tests.
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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.

85%

less manual labor

$900K

annual holding cost savings

$75K

lower investigation costs

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.

STEP BY STEP

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:

Step 1: Sample Preparation
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.

Step 2: Load Growth Direct® Sterility System

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.

GLOBALY RECOGNIZED 

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.

Growth Direct system used for rapid sterility testing in GMP facility
Growth Direct system used for rapid sterility testing in GMP facility

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 5 Steps to Implement Rapid Sterility Testing for best practices and implementation insights.

GET EXPERT SUPPORT

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.

BEYOND STERILITY TESTING

Explore Other Applications

Extend the benefits of automation to every stage of QC, from water testing to environmental monitoring, with the same speed and data integrity you trust.

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Water Testing
Bioburden Testing

Bioburden Testing
Environmental Monitoring

Environmental Monitoring