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RAPID, COMPLIANT WATER TESTING

Ease Your Load in QC Water Programs

Accurate CFU results in ~36 hours instead of 3–5 days — with positives detected as early as 16 hours.
Same compendial method. Less manual work. Faster trending and response.

 

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Ask Rapid: Validating Water Testing
MODERNIZING MICROBIAL QC

What Is Automated Water Testing?

Automated microbial water testing with Growth Direct® digitizes membrane filtration workflows: early microcolony detection via autofluorescence, robotic incubation, and image-driven enumeration without changing your R2A-based compendial process.

QC microbiology automation platform improving data integrity and reducing manual errors
WHY IT WORKS

Key Benefits

Automated water testing with Growth Direct® gives QC labs faster, more reliable results without changing the compendial membrane-filtration method. By combining early microcolony detection, robotic incubation, and fully digitized records, the system reduces manual effort, strengthens compliance, and ensures confident trending across Purified Water (PW), Water for Injection (WFI) systems.

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Faster, accurate results

Sensitive imaging detects microcolonies early, delivering results in ~96 h vs ~7 days.

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Non-destructive and traceable

Positive samples remain intact, enabling extended incubation or downstream microbial ID.

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Reduced manual labor

Automates incubation, colony enumeration, and data entry, freeing analysts from repetitive tasks.

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Data integrity built-in

Barcode tracking, audit trails, and 21 CFR Part 11 compliant software eliminate transcription risk.

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Validated equivalence

Demonstrated equivalence and reproducibility vs manual methods, simplifying validation and regulatory acceptance.

PERFORMANCE AT A GLANCE

Manual vs. Automated Bioburden Testing

Traditional water testing workflows are slow, labor-intensive, and prone to variability. By automating the same compendial process, Growth Direct® delivers faster, more reliable results — giving teams the data they need sooner to make confident release decisions.

QC microbiology automation platform improving data integrity and reducing manual errors
AUTOMATION WITHOUT DISRUPTION

Seamless Integration with Your Existing Water Workflow

Follows your compendial setup

R2A membrane filtration at 30–35 °C remains the same. Growth Direct® replaces reading and handling steps without changing your core QC method.

Fits your lab footprint

R2A cassettes and filters integrate seamlessly, minimizing revalidation rework.

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ONE SYSTEM FOR ALL WATER TYPES

Media & Cassette Technology

Growth Direct® supports QC microbial testing across Purified Water (PW), Water for Injection (WFI), clean steam condensate, and rinse waters.

  • Pharmacopeial media — R2A agar cassettes for water testing, aligned with compendial methods.

  • Cassette technology — Automated format designed for robotic handling, early microcolony imaging, and secure barcoded sample traceability.

  • GMP consumables — Media-filled cassettes produced in controlled cleanroom environments and irradiated for sterility and long shelf life.

  • Digital trending & reporting — Electronic data capture with LIMS integration supports loop and POU trending, while Growth Direct® delivers real-time insight for early alert and action level detection.

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COMPLIANCE & INTEGRATION MADE CLEAR

Frequently Asked Questions

Get answers to the most common regulatory, validation, and integration questions about Growth Direct®.
Is the method recognized?

Yes. Growth Direct® automates the same compendial membrane-filtration, growth-based method used for PW and WFI water testing. It is not an “alternative method.” Validation follows PDA TR-33, USP <1223>, and Ph. Eur. 5.1.6 guidance to demonstrate equivalence.

What types of water can be tested?

Growth Direct® supports Purified Water (PW), Water for Injection (WFI), clean steam condensate, and rinse waters, aligned to your site’s sampling plans and regulatory requirements.

Can positives be sent for identification?

Yes. The method is non-destructive. Positive cassettes can continue incubating or be removed and routed to microbial identification systems without losing sample integrity.

Is the software compliant and compatible?

Yes. Growth Direct® is 21 CFR Part 11–ready, with secure audit trails, role-based access, and barcode-enabled sample traceability. The platform integrates directly with LIMS, eliminating transcription errors and enabling digital trending by loop or point of use.

GET EXPERT SUPPORT

Faster, validated water testing starts here

Digitally transform your routine water testing with the same compendial confidence, now delivered faster, accurately, and completely traceable.

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BEYOND WATER TESTING

Explore Other Applications

Extend Growth Direct® automation across your core QC microbiology program.

Environmental Monitoring

Environmental Monitoring
Bioburden Testing

Bioburden Testing
Sterility Testing

Sterility Testing