Microbial quality control (QC) testing has made strides over the last several years. And as technologies such as the Growth DirectTM System advance, the easier it becomes to quantify and justify the economic benefits. The automated system, which utilizes rapid microbial methods (RMM), analyzes user-prepared samples—just as the traditional method would—and is designed to optimize microbial test performance and ease of use.
Get to know the Growth DirectTM System. Check out our video or check out the information below. In less than five minutes, you’ll understand the difference one investment in rapid automation can make for your QC efforts.
The Growth DirectTM System expands the reach of automated rapid microbial detection. Providing positive results in hours and final results in half the time of current methods without the use of additional reagents and/or without destroying the sample.
The Growth DirectTM System lets you gain valuable production days and improve production efficiency, while minimizing production costs. Built on proven methods, the Growth DirectTM System supports all your microbial testing needs. For environmental monitoring, the system can automate your air, surface and personnel testing. The sample prep mirrors your current processes, using the same media type and popular air monitors.
For sterility testing, sample preparation mimics the existing method, and can take place in an isolator or biological safety cabinet using existing pumps and drains. The method ensures closed-loop sampling using three cassettes, two aerobic and one anaerobic to mimic the conditions of the compendial test. The application handles samples from vials, ampoules, syringes or IV bags.
For bioburden testing, sample preparation is identical to the compendial method, samples are filtered and the membrane is placed on a growth cassette containing nutrient media such as R2A, TSA or SDA. There are no additional enrichment or preparation steps.
The device is designed for high throughput and includes two incubators that simultaneously hold up to 700 samples. The technology can be configured for multiple protocols, each with specific incubation times, temperatures, alert and action limits. Loading samples into the Growth DirectTM System is easy and flexible. Prepared samples can be delivered as full carousels, stacks or individual cassettes, and they are efficiently loaded into the incubators within minutes.
The unique cassette ID number interfaces with facility laboratory information management systems (LIMS) to automatically handle the cassette according to the selected application protocol and paperlessly report results both on the system and remotely. Advanced robotics allow for simultaneous scheduling, loading, unloading and imaging for fast, efficient operation. Samples are examined with the next generation optical imager, which detects all types of growing microbes, just like the traditional visual method.
Inside the imaging chamber, without the addition of any chemicals, blue light causes microbial colonies to autofluoresce, and the system counts the fluorescent colonies. Growth DirectTM System can detect as little as one colony forming unit (CFU), and each CFU can be detected as a micro colony containing as few as 100 cells. The detection technology is effective with a variety of microbes, stressed organisms and difficult samples.
In hours, the Growth DirectTM System can detect microbial contamination, but, unlike other methods, is non-destructive. Once the test is complete, samples can be discarded or cassettes with colonies can be returned to the incubator until the colonies are visible. Then, the cassettes can be retrieved to conduct microbial identification analysis.
Alerts can be sent immediately and automatically to QC and manufacturing for early intervention. Results can be downloaded directly to any LIMS. Early detection with the Growth DirectTM System improves production efficiency, gaining valuable production days while minimizing production costs.
The Growth DirectTM System is the only rapid enumeration device that accelerates and automates detection. With no changes in test preparation, it's the only rapid system that automates microbial QC tests and preserves colonies for identification.
Ready to start quantifying the economic benefits of the Growth DirectTM System? This free guide offers important considerations—get it today.