In addition to rapid results, growth-based RMM technology provides a key benefit for microbiologists seeking more accurate and reliable colony counts: a far larger dynamic range. When using the compendial method, most quality control labs dilute their samples to achieve colony counts of 100 or fewer, with 300 being the standard upper range for manual detection. Even at those numbers, however, overgrown colonies of different sizes can make it extremely difficult for technicians to achieve consistent counts.
Technological advances like the Growth Direct™ System's charged-coupled device (CCD) imaging technology allows for far greater dynamic range and linearity. By detecting CFUs through autofluorescence – rather than manual, visual counting – the system can detect microcolonies at as few as 100 cells. It can also achieve accurate CFU counts of well over 1,000, providing users with a range ten-fold or greater than they can achieve with the traditional method. The following are just a few of the benefits of this critical capability.
With the ability to detect extremely low and extremely high numbers of CFUs, microbiologists can perform far fewer dilutions on highly concentrated samples – or even avoid them altogether. They can then devote this extra time to investigations, interventions and other important tasks.
- Removing Human Errors: As simple as dilutions can be, each one increases the potential for error and incorrect colony counts. By reducing or eliminating dilutions, microbiologists can improve the accuracy of results and ensure that out-of-specification investigations they perform are truly necessary.
- More Reliable Results: Dilution errors aside, the imaging technology produces more accurate and reliable results than the naked eye. While linearity becomes difficult to achieve after roughly 300 CFUs with the manual method, the Growth DirectTM System maintains its linearity well into the thousands of microcolonies.
- Automated Reporting: In the instances where a dilution is still needed, Growth DirectTM System users need only perform manual work during sample preparation. To obtain an accurate count, the system allows for entry of extra information to perform all necessary calculations to find the microbial content of the original samples.
Far-Reaching Benefits of Automated Enumeration and Reporting
The Growth DirectTM System's greater range and rapid results don't just benefit quality control personnel; they have far-reaching benefits for all stakeholders within pharmaceutical companies. These benefits include:
- Greater Resource Efficiency: Through the reduction of dilution steps, incubation transfers, colony counting and reporting, manufacturers can realize greater resource efficiency in their QC departments. These highly trained, highly educated workers can then spend their time on higher value activities.
- Fewer Investigations: Through faster enumeration and reporting, companies can avoid most of the costly and unnecessary out-of-specification investigations that might otherwise result from improper dilutions, miscounts and erroneous reporting.
- More Buy-in From Manufacturing Personnel: The Growth DirectTMSystem is unique in that it doesn't have to be placed in the typical QC laboratory setting; it can reside close to manufacturing lines themselves.
- Faster Times to Market: Ultimately, faster testing and the elimination of repetitive tasks allows manufacturers to ship their products to retailers sooner. Faster shipping also allows companies to potentially operate with less warehousing or to take greater advantage of the space they've already built.
Are you ready to learn more about the benefits growth-based RMM holds for your QC department? If so, watch this video on the application of the Growth DirectTM System to sterility testing and environmental monitoring.