Now that more manufacturers are looking to trim the fat in their quality control processes, microbiologists are under heavy pressure to produce faster, more accurate and more reliable results. Rapid microbial enumeration is one of the best ways to achieve these goals, but not all rapid technologies are alike. Systems that work well in some environments may not be suitable for others, and pharmaceutical organizations must choose the correct method to achieve the optimal result and ROIs. Here are seven considerations for companies that want to make the move to rapid methods.
- Testing Type: Most microbiological tests in the QC environment fall into one of four categories: water, bioburden, environmental monitoring or sterility. Depending on their exact applications, they may require different sample preparations, incubation times and reporting procedures. Manufacturers should consider whether they need to streamline one or all of these tests, and choose a system that suits their goals and requirements.
- Required Throughput: Similarly, microbiologists will need to consider the throughput necessary for currentand future tests. Most rapid systems allow for higher volumes than the traditional method, but some can handle far more samples than others. In environments with massive volumes of raw ingredients, in-process batches and final products to test, a high throughput is crucial to maintain manufacturing uptime and move inventory as quickly as possible.
- Minimum Time Savings: Rapid methods are faster than traditional colony counting, but the fastest system isn't necessarily the best. While same-day results are certainly useful in certain situations, they often bring drawbacks: sample destruction, potentially higher false positive rates or a lack of quantitative data. On the other hand, non-destructive methods can still cut times-to-results in half compared to the traditional method. Overall, stakeholders should determine the minimum time savings needed to create value and choose other attributes accordingly.
- Sample Preparation: Different rapid methods may also require different steps for sample preparation. Rapid methods that require different preparation steps than traditional methods will require additional training and SOP updates. Ideally, the rapid method should closely match the existing sample preparation steps, minimizing the impact to quality control technicians.
- Labor Efficiency: Faster times-to-results may not lead to reduced costs if they require additional labor. More paperwork, extra steps and complicated sample preparations can ultimately increase work on the part of highly trained, highly paid microbiologists. Still, other systems can drastically reduce human involvement through the automation of mundane procedures. Ultimately, QC departments that want to save both time and money will need to strike a balance between speed and efficiency.
- Error Reduction: Error reduction is one of the greatest potential benefits of rapid enumeration. While some methods require extra human intervention– and thus create greater potential for mistakes – others automate the most error-prone processes. Given the right equipment, colony counting, incubation changeovers and data entry can all become far more reliable.
- Quantitative Results: Certain tests require only a yes or no answer, but many necessitate accurate enumerations. Furthermore, large dynamic ranges (0 to 1,000 colony forming unit, for instance) can eliminate the need for sample dilutions and additional tests. The best system for any given environment will offer range and accuracy that fit all required applications.
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