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Automated EM Excellence

The Gold Standard in Automated Environmental Monitoring

Digitize your EM program with the trusted system that accelerates microbial QC, cuts TTR, optimizes labor, and ensures GMP-compliant data integrity at scale.
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WHITEPAPER
EXAMPLE
QC microbiology automation platform improving data integrity and reducing manual errors
PROVEN BY TOP PHARMA

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.
 
 
GLOBAL-SCALE RESULTS
Lonza
5-2
 <72-Hour TTR
First end-to-end digital EM workflow deployed across global sites - dramatically reducing TTR. 
4-2
2-Minute Sample to Approval
Automated system enables digital result review and approval in under 2 minutes.
7-2
Up to 20% FTE Cost Savings
Staff redeployment and efficiency gains reduced labor costs across EM operations.
View Lonza’s End-to-End EM Case Study
OLD WAY VS. NEW WAY

Manual vs. Automated Environmental Monitoring

End-to-end automated environmental monitoring workflow with Growth Direct®
COMPLIANCE & INTEGRATION MADE CLEAR

Frequently Asked Questions

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

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
How is Growth Direct® validated for automated environmental monitoring?

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.

Does Growth Direct® integrate with LIMS and informatics 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

talk to our Experts

See Growth Direct® in Action

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

Request a Demo
THE CASE FOR CHANGE

Why Modernize Your Environmental Monitoring Program?

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

9-1
Manual methods increase compliance risk
Transcription errors, paper records, and inconsistent reviews create audit vulnerabilities and deviation investigations.
10-1
Slow TTR delays critical decisions
Waiting 5–8 days for results stalls root cause analysis and product release — impacting throughput and responsiveness.
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Growth Direct® offers a smarter path forward
Fully automated and digitized, it delivers real-time data, site standardization, and greater efficiency in GMP environments.
View Lonza’s End-to-End EM Webinar
AUTOMATION WITHOUT DISRUPTION

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.

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.

Growth Direct® system automating incubation and colony detection for EM samples
ONE SYSTEM FOR ALL EM SAMPLES

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.

YOUR SAVINGS IN NUMBERS

Estimate Your ROI with Growth Direct®

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

Get Your Estimate
BEYOND ENVIRONMENTAL MONITORING

Explore Other Applications

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

Water Testing

Water Testing
Bioburden Testing

Bioburden Testing
Sterility Testing

Sterility Testing