Rapid microbiological methods (RMM) have become more prevalent in the pharmaceutical industry over the last few years, and quite a few companies are now using a rapid method to achieve faster results. Typically, the method is used for a specific application, such as water testing or sterility, with few companies using a single rapid method across all key applications.
As businesses look for ways to improve throughput and efficiency, particularly in areas that may still be using manual processes, an area of opportunity is that of the microbial quality control lab, which is still dominated by the traditional, manual method. When considering a change to a rapid method, read on to learn six key aspects of automated, growth-based RMMs.
- It Mimics the Traditional Method
Although the compendial method for colony enumeration is inefficient, it is time-tested and accepted among regulatory authorities. Automated, growth-based rapid methods such as the Growth DirectTM System take the best of the traditional assay and automate the techniques microbiologists are familiar with. Users need only prepare sample cassettes using familiar procedures, and the system takes care of the rest. The system enables internal robotics to transfer samples from one incubator to the next; features a charged-coupled device (CCD) imaging system that counts colonies long before they've grown large enough to view with the naked eye; and automatically reports the data in colony-forming units.
- It Utilizes Non-Destructive Technology
Another advantage automated, growth-based rapid methods hold is their non-destructive nature. Many rapid methods require reagents to determine a result. These reagents are often destructive to the sample, requiring additional effort in the event of a positive result. With automated, growth-based methods, samples are preserved and users can immediately take a sample of interest for identification. Ultimately, this capability allows microbiologists to more quickly initiate an out-of-specification investigation and contain problem areas when necessary.
- Is Designed to Support the Bulk of Microbiological Testing
Due to similarity to the traditional method, automated, growth-based RMMs can be used for most microbiological tests including water and bioburden, environmental monitoring and sterility testing. Quality control labs have the option of replacing the manual method with a single system, and little to no training (or retraining) is required.
- Supports High-Volume Testing
An automated growth-based system, such as Growth DirectTM, can handle large volumes of tests per day and sample preparation mirrors existing preparation methods. Ultimately, the ability to support high volumes allows manufacturers to increase capacity without requiring proportional increases in quality control resources.
- It Can be Located Near Production Lines
A challenge for pharmaceutical manufacturers that have large campuses is the time and effort required to capture samples and return them to the lab for testing. On the other hand, growth-based equipment such as Growth DirectTM is self-contained and can be placed near the production lines. In fact, manufacturing personnel could even be trained to prepare and load samples--saving time.
- It Offers Results in about Half the Time
Another benefit of automated, growth-based RMMs is the rapid results users can achieve. The Growth DirectTM System for microbial enumeration can produce comparable results to the culture method in about half the time, and because it is non-destructive, it allows for identification and followup investigations.
If you're interested in speeding up your quality control operations or want to learn more about the benefits of growth-based RMM, download a free guide today.