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GROWTH DIRECT BROCHURE

Learn about the important advantages Growth Direct offers your facility

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    The Gold Standard in Automated Environmental Monitoring

    Digitize your EM program with the system trusted by leading pharmaceutical manufacturers to accelerate microbial QC, reduce TTR, optimize labor, and ensure GMP-compliant data integrity at scale.

    Trusted by Leading GMP Manufacturers 

    Top pharmaceutical and advanced therapy producers trust Growth Direct® to automate environmental monitoring, reduce time-to-result, and enhance data integrity — all while maintaining compliance and cutting operational costs.
     
    See how industry leaders are putting Growth Direct® into action — from reducing turnaround times to enabling fully digital, end-to-end QC workflows.

    Lonza

    Global implementation at scale

     <72-Hour TTR

     First end-to-end digital EM workflow deployed across global sites — dramatically reducing time-to-result. 

    2-Minute Sample to Approval

    Automated system enables digital result review and approval in under 2 minutes.

    Up to 20% FTE Cost Savings

    Staff redeployment and efficiency gains reduced labor costs across EM operations.

    Manual vs. Automated Environmental Monitoring

    End-to-end automated environmental monitoring workflow with Growth Direct®

    Watch Growth Direct® in Action

    Frequently Asked Questions

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

    Yes. Growth Direct® supports global GMP and data integrity requirements, including:

    • The system has been successfully inspected in FDA- and EMA-regulated facilities.
    • FDA 21 CFR Part 11
    • EU Annex 1
    • EMA and MHRA guidance
    • ALCOA+ principles for data integrity

    The Growth Direct® System is validated through a risk-based, regulatory-aligned approach tailored to environmental monitoring in GMP-compliant facilities. Most customers complete validation in approximately four months, supported by expert guidance and documentation.

    Proven validation experience

    Validated at leading pharmaceutical and biotech sites worldwide, Growth Direct® supports both standard qualification packages and site-specific PQ protocols.

    Complete validation lifecycle

    Our validation support includes:

    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • 21 CFR Part 11 compliance
    • Method Qualification / Suitability (MQ/MS)
    • Bi-directional LIMS integration

    Expert-led, high-touch support

    Validation begins prior to system purchase, with early consultation from a dedicated expert. Our team provides direct support throughout implementation—without triage delays.

    Seamless LIMS and data integration

    The system’s universal communication platform enables reliable .csv exports and integration with LIMS, trending databases, and quality systems.

    Yes. Growth Direct® integrates with leading informatics platforms, including:

    • LIMS systems used across QC and QA labs
    • Middleware solutions for seamless data exchange and automated result reporting

    This integration enables real-time data transfer, digital audit trails, and enhanced traceability across your quality control network.

    Read full article: RMB - Lims - White Paper-V3.pdf

    Why Modernize Your Environmental Monitoring Program?

    Manual EM processes were never designed for today’s speed, compliance, and global QC demands.

    Manual methods increase compliance risk

    Transcription errors, paper records, and inconsistent reviews create audit vulnerabilities and deviation investigations.

    Slow TTR delays critical decisions

    Waiting 5–8 days for results stalls root cause analysis and product release — impacting throughput and responsiveness.

    Growth Direct® offers a smarter path forward

    Fully automated and digitized, it enables real-time data access, standardization across sites, and greater operational efficiency in GMP environments.

    See Growth Direct® in Action

    Discover how automated EM can streamline compliance and reduce manual effort.

    Seamless Integration with Your Existing Workflow

    Follows Your EM Process. From sample collection to cassette loading, incubation, and digital result review — Growth Direct® automates your QC lab’s standard environmental monitoring workflow.


    Uses Your Validated Tools. Fully compatible with common active air samplers — no need to change or revalidate equipment.

    Maintains Sampling Protocols. Supports existing GMP-compliant EM procedures and layouts, ensuring a smooth transition to lab automation.


    Enhances Safety with a Closed System. Reduces contamination risk and operator exposure by eliminating manual plate handling.

    Cassette & Sample Compatibility

    Growth Direct® is designed to support a full range of environmental monitoring needs in GMP-regulated environments. It is compatible with all key EM sample types, including air, surface, personnel gowning, and water samples—covering major contamination control points.

    The system uses standard media formats such as TSA (LP80 and LP80HT) and R2A plates with neutralizers, eliminating the need for specialized or proprietary media.

    Each 55 mm cassette includes a barcode for automated sample identification and traceability, enabling seamless data capture and ensuring audit readiness.

    Built for GMP-compliant workflows, Growth Direct® supports automated incubation and colony detection, reducing manual handling and improving consistency across QC operations.

    Estimate Your ROI with Growth Direct®

    Get a personalized look at efficiency gains and cost savings for your site.

    Get Your Estimate
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