Environmental monitoring is likely just one of many microbial tests you perform on a daily basis. It’s also likely that your quality control (QC) laboratory still uses the compendial method to conduct these tests. And though the method is time-tested, you know all too well it’s time consuming and prone to manual error.
The micro QC lab is being asked to do more and more with fewer resources. It’s becoming increasingly important to find ways to increase efficiencies in the lab, such as leveraging lean initiatives. This is where automated rapid microbial methods (RMM) for quality control (QC) testing can be valuable. Designed to improve efficiency, RMMs can deliver the results QC labs are required to provide—in less time.
As with any industry or position, microbiologists must be capable of demonstrating the value a new product or solution can add to their organization. As a result of this demand, they must be able to answer questions specific to the testing methods for which they are responsible.
Following are some of the most frequently asked questions Rapid Micro Biosystems receives regarding our Growth DirectTM System as it pertains to environmental monitoring.
Q: How does the Growth DirectTM System achieve the same results as the compendial method?
Designed upon the same methodology as the compendial method, the Growth DirectTM System simply automates the process. And rather than utilizing reagents, it analyzes the natural autofluorescence of the growing cells and tracks growth over time.
Q: Does the Growth DirectTM System need to be in my lab?
No. Because the instrument is self-contained, with built-in incubators, imaging and detection software, the system can be placed virtually anywhere. Some companies have chosen to place the instrument closer to the manufacturing area to shorten travel time, particularly in large campuses.
Q: What samples can be tested?
The equipment can test air, surface and personnel samples.
Q: What is the expected throughput?
For a three-day test at one temperature, the system can process more than 450 samples per day. For a five-day test at two temperatures, about 230 samples can be processed per day
Q: Does my sample preparation need to change?
No, sample preparation would mirror your existing processes.
Q: Would this be validated as an alternative method?
No, the method mirrors the current environmental method and simply automates it. Generally, only accuracy and precision testing are required validation criteria.
Q: What kind of services and support are available?
Rapid Micro Biosystems provides multiple levels of support including:
- On-site installation
- Instrument services
- Validation services (i.e., IQ, OQ, PQ and Method Validation, including full documentation package and on-site support)
- Regulatory compliance assistance
- Technical support throughout the Americas and Europe
- System certification training and training refreshers
Q: Is integration to LIMS available?
Yes. The Growth DirectTM System for environmental monitoring seamlessly integrates into existing laboratory information management systems (LIMS)—accelerating the availability of sample data beyond the lab and eliminating potential keying errors associated with manual processing.
Don’t miss the next edition of this series as we discuss common questions and features regarding sterility testing processes. Subscribe to our blog today to have it delivered directly to your inbox.