Pharmaceutical manufacturers have used Laboratory Information Management Systems (LIMS) for years to streamline workflows and share and track data through powerful but user-friendly interfaces. By integrating LIMS with a variety of automated systems in the manufacturing process, these companies have been able to save time, eliminate redundancies and reduce the potential for human error.
While the industry has been slow to apply the same innovations to quality control labs, LIMS integration is possible with automated, rapid microbiological methods (RMM) like the Growth DirectTM System. The technology can integrate with users' existing LIMS, automatically recording, and sharing test results with the rest of the organization.
Limitations of the Traditional Testing Environment
Why is integration of microbial quality control test results with LIMS beneficial? For starters, the traditional, non-automated, non-integrated testing environment requires microbiologists to perform a variety of repetitive manual tasks, and it creates the potential for errors that can create costly investigations.
- Hand written information can be illegible or mis-interpreted.
- Handling of paper documentation can create filing errors.
- Manual entry of data into non-integrated LIMS can result in data entry errors.
These manual tasks can be all but eliminated by integrating the Growth DirectTM System with a LIMS, resulting in cost and time savings. The need for corrections is greatly reduced as transcription errors are eliminated. In one study, a 57 percent time reduction with the LIMS-integrated Growth DirectTM System was realized when compared to the conventional data entry method.
Workflow with Two-Way LIMS Integration
Want to see just how the process works from test initiation to final results with the LIMS-integrated Growth DirectTM System? Below is one step-by-step process, but the system can be configured to be aligned to your use of LIMS and barcoding:
- Initiate the Process. The user submits the request file to the Growth DirectTM System and prints the LIMS barcode labels from either the existing label printer or the system's proprietary printer.
- Generate Barcodes. LIMS barcodes are generated with a special character and LIMS ID to be read by the system during enumeration.
- Collect. Samples are collected according to the company's standard operating procedures using the same techniques the compendial method requires.
- Apply Barcodes. The user applies the LIMS labels, each of which contains the LIMS ID and optional custom text, to the sample cassettes.
- Load Cassettes into Growth DirectTM System. The labeled cassettes are loaded on to the system for incubation and enumeration. Barcodes are automatically scanned for sample identification, and notifications can be sent if samples aren't loaded after a user-defined time period. Alerts can also be sent as soon as a sample's microbial load exceeds specifications.
- Results Uploaded to LIMS. The test results are immediately uploaded into the appropriate folders, which can be user-configured ahead of time.
The main requirements to implement two-way LIMS integration include the following:
- The LIMS must be able to provide a test request file, typically a text document, to the Growth DirectTM System.
- The LIMS must be able to receive a test results file, also usually a text document, from the Growth DirectTM System
Even if two-way integration isn't feasible for your lab today, you can still reap many of the same time-saving benefits without integrating to LIMS, or performing a one-way integration where initiation of the test occurs at the Growth DirectTM System, and the test results are automatically sent to the LIMS.
Want to learn more about LIMS? Discover the benefits in this short article.