The Growth Direct^® System

Q: What is 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.

Q: Which microbiological tests can I run on Growth Direct®?

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.

Q: How fast are results compared to traditional methods?

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.

Q: Is the Growth Direct® System aligned with regulatory expectations for rapid microbiological methods (RMM)?

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

Q: Can the Growth Direct® System integrate with my LIMS or MES?

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.

Q: How does the system support data integrity and compliance?

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.

Q: What throughput and capacity does Growth Direct® offer?

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.

Q: Is Growth Direct® suitable for ATMPs, biologics, and other complex products?

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.

Experience the difference of a fully automated, growth based, rapid microbiological method (RMM) platform

Reduce TTR by days with the fully automated rapid microbial detection platform

One platform for environmental monitoring, water testing, bioburden, and sterility testing

The Growth Direct^® System is the industry's leading fully automated rapid microbiological method (RMM) platform. The system automates loading, incubation, imaging, and reporting. Simply drop off your samples and walk away, gaining significant labor savings and improved sample integrity. The Growth Direct system modernizes microbiology QC, accelerates pharmaceutical release times, and ensures high data and sample integrity across global pharmaceutical and CDMO laboratories.

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

Automated, non-destructive, growth-based rapid microbial detection (Automated RMM)

Applications	EM (Surface, Air & Water), BioBurden, Sterility
Automation	Full end-to-end automation of loading, incubation, imaging and unloading to waste or output queue
Cassette Media	55mm. TSA, TSA LP80, TSA LP80HT, SDA, R2A
Incubators	Two incubators -- for use as dual temp or for single temp at double capacity (and redundancy)
Sample Capacity	660 cassettes (plus 40 buffer locations)
Time to Detection	12 hrs*
Time to Results - EM	32 hrs*
Time to Results - Water	48 hours*
Time to Results - BioBurden	24 hours*
Time to Results - Sterility	5 days*
Input Options	1 to 120 cassettes (single or bulk load)
Output Options	Waste bin or output queue
Imaging	Fluorescence, high-resolution
Accuracy - False Positive**	<0.5%
Accuracy - False Negative **	≤0.1%
Mold Detection	Yes, with Mold Alarm
Throughput	Up to 220 cassettes/day (up to 70k per year)
LIMS Support	Yes, integration with multiple LIMS software products
21CFR11 Compliant	Yes
Weight	1,187 KG (empty)
Electrical Requirements	200-240VAC, single phase. 15A.
Air	Compressor air, 6-10bar (85-145psi)
Certification	ETL Listed, CE certification. ISO 9001

* In as few as the listed number of hours/days; denotes typical validated results
** Typical validated accuracy

Definitions
Time to Detection (TTD)	The earliest possible timepoint at which the Growth Direct can identify growth and send an alert.
Time to Results (TTR)	The earliest timepoint at which final results (count in CFU, growth or no growth) can be reported. Determined as part of validation.
False Negative (FN)	A growing colony that is not counted by the Growth Direct System, on a per colony basis.
False Positive (FP)	An incorrect identification of a growing colony by the Growth Direct System that is not associated with microbiological growth, on a per colony basis.

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