The Growth Direct® System

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The Growth Direct® System

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The Technology of Rapid Detection

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Process Automation and Error Reduction

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Delivering Unparalleled Value

Benefits at a Glance

DATA INTEGRITY Secure critical data to ensure global quality and regulatory compliance.

OPERATIONAL EFFICIENCY Deliver faster automated results for improved decision making and business performance.

INSIGHT AND ACCURACY Eliminate human quality control errors and reduce business risks.

Labor Efficiency and Cost Savings

Simplify workflow and investigations
Optimize retention and employee engagement
Reduce PPE and departmental costs

Flexible, Fast LIMS Integration

Universal communication platform for seamless connectivity
Easy data sharing with a variety of systems and networked programs
Secure networking with remote monitoring and email connectivity for alerts and rapid response

Improved Data Integrity

Prevention of errors and contamination resulting from manual handling
Fewer out-of-specification investigations
Reduced opportunity for falsification
FDA-compliant with 21 CFR Part 11

Faster Detection, Easier Root Cause Analysis

Automated detection and counting of microbial colonies in half the time
Non-destructive testing for quicker identification of a positive result
All samples uniquely barcoded
Digitized data for a complete audit trail

Scalable for High Volumes

Faster lab response to new production lines
More time to meet production targets
Reduced product losses
Flexibility to bring new Growth Direct® units online as your needs increase

Implementing the Growth Direct®
System at Biogen

See how Biogen automated plate reading at QC microbiology labs around the globe, cutting bioburden and environmental monitoring incubation times in half while integrating seamlessly with company LIMS.

Frequently Asked Questions about the Growth Direct® System

The Growth Direct® System is an automated, non-destructive rapid microbial detection platform designed for QC microbiology. It automates incubation, imaging, and detection, removing manual plate handling and supporting a fully digital workflow for environmental monitoring, bioburden testing, water testing, and rapid sterility testing.

Growth Direct® supports multiple QC microbiology workflows, including environmental monitoring (EM), bioburden testing, water testing, and rapid sterility testing. Because the system uses familiar agar-based methods, labs can adopt automation without changing their underlying test principles.

Traditional compendial methods often require several days to weeks for results. Growth Direct® enables earlier detection by continuously monitoring plates during incubation. For certain validated rapid sterility workflows, labs can achieve actionable results in less than 72 hours, helping accelerate batch release and reduce inventory hold times.

Yes. Growth Direct® is an agar-based rapid microbiological method that can be validated following established regulatory and pharmacopeial guidance for alternative microbiological methods (e.g., USP and Ph. Eur. chapters on RMM validation). As with any RMM, users perform method validation to demonstrate equivalence or improvement relative to their current compendial method.

Yes. Growth Direct® offers connectivity options for integration with LIMS, MES, and other digital systems. This allows secure transfer of plate data, sample information, audit trails, and results—reducing manual transcription, supporting data integrity, and enabling a more automated QC workflow.

Growth Direct® provides controlled user access, secure electronic records, audit trails, and electronic signatures within its software environment. These features support data integrity principles and help facilitate 21 CFR Part 11–compliant deployments in accordance with site quality procedures.

The Growth Direct® System is designed for medium- to high-volume QC labs. It automates incubation and imaging for large plate loads across EM, bioburden, water testing, and rapid sterility applications—enabling labs to manage increasing sample volumes without adding manual workload.

Yes. Growth Direct® is used in manufacturing environments including ATMPs, biologics, sterile injectables, and other high-risk products where earlier microbial detection supports faster decision-making. Its agar-based approach and automation make it suitable for both established and emerging therapeutic modalities.

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The Growth Direct® System