Managing Key Microbial Quality Control Tests within a Single Technology

By Mark Severns. Rapid Micro Biosystems.

When speaking with microbial quality control professionals, a common list of needs to become more efficient, reduce errors and provide micro QC results faster appears. The list typically includes items such as:

• Perform the testing on a single system

• Have the system do all the colony counting

• Automatically record and send results to the laboratory information management (LIMS) system

• Get results faster

• Do serial incubation transfers automatically

• Provide a complete and comprehensive audit trail

Non-destructive, automated, rapid microbial testing through technologies such as the Growth Direct™ System address these needs. These technologies provide the unique capability of performing the three key microbial quality control tests within a single, self-contained, automated instrument. The system automates the incubation, detection and results reporting steps for bioburden, environmental monitoring and sterility testing – within a single instrument. A unique technology, the Growth Direct System provides automation, efficiency and rapid results in a single instrument.

Using automated technologies like the Growth Direct System, technicians prepare samples using familiar techniques. Sample preparation mirrors the traditional method. Once prepared, samples are loaded into the instrument for incubation, enumeration and detection of growth.

Environmental Monitoring

Air, surface, and personnel samples are prepared in the same way as the traditional method. Because of the large sample volumes and ongoing testing requirements, automation and speed are particularly helpful for environmental monitoring.

Bioburden Testing

Products are filtered through 0.45 micron filter on standard vacuum manifolds. The technology automates and manages the rest of the process, from enumeration to incubation transfers (if needed) to reporting. For a typical 7 day water test, the Growth Direct System will deliver comparable results, reporting in colony forming units (CFUs) in about half the time.

Sterility Testing

The Growth Direct System sterility test uses the pumps and drains already present in isolators. Users follow the familiar procedures of filtering their samples. Once prepared, the samples, both aerobic and anaerobic, are loaded into the instrument for incubation and detection. For the traditional 14-day sterility test, the Growth Direct System will provide positive results starting in hours, and final results in 7 days—about half the time of the traditional test.

A Self-Contained Instrument

Manual sterility tests are often conducted in separate incubation environments, but the Growth Direct System is self-contained and all cassettes (sterility, environmental monitoring, and bioburden) remain sealed during incubation and detection. Labs can opt to run multiple applications in the same instrument without concern of cross-contamination.

By automating and accelerating the familiar processes of the compendial test, automated, rapid technologies like the Growth Direct System improve production efficiency, reduce time to results and decrease production costs. Quality control personnel can focus fewer hours on repetitive tasks and investigations while reallocating time to high value projects such as test design or SOP development. The following attributes allow the system to achieve these results.

Advanced Imaging Technology

The Growth Direct System enumerates growing colonies (reported in CFUs) with a sensitive camera. The system performs the imaging process at regularly scheduled intervals, and advanced algorithms analyze the images to detect growing colonies. The technology can detect and report on growing colonies starting within hours.

Two Incubators

The system automates the incubation process. Two incubators with high density cassette hotels hold a high number of samples, making it easier for users to automate large testing volumes. In a serial incubation scenario, internal robotics will transfer cassettes from one incubator to the other at the appropriate time, eliminating the chance for transfer errors that can lead to costly investigations.

LIMS Integration

While the system can operate stand-alone, it can also integrate with a company’s existing laboratory information management system (LIMS). One-way or two-way LIMS integration allows users to further automate the testing process, potentially lessening paper, removing the need to enter final results, and eliminating the potential for manual errors that can lead to a costly investigation.

Non-Destructive Testing

Finally, the Growth Direct System does not involve the use of any destructive reagents or tags to create the fluorescent signal. Because all tests performed on the instrument are growth-based, users have the ability to take samples of interest to a microbiology identification system for follow-up identification tests on the sample, a critical component of good manufacturing practices.


An All-in-One Solution

Automated technologies like the Growth Direct System not only offer automated, non-destructive, rapid results – they can also perform all three major microbiological tests within the same instrument. Labs get bioburden, environmental monitoring, and sterility test results in about half the time of the compendial method, integrated to LIMS, all obtained with the precision and reliability of an automated, self-contained instrument.

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