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Creating the QC Lab of the Future Now

Lab Optimization Master Series

Posted by Rapid Micro Biosystems on April 8, 2020

Can Rapid Micro Methods Improve Functional and Operational Efficiencies? Yes, and many QC Directors and Managers are successfully leveraging the use of rapid microbiological methods, also called alternative microbiological methods, to drive operational efficiencies in their labs.

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Yet, a large sector of the industry is hesitant to embrace those methods. Those who still operate manually may not realize that rapid micro methods can help them reach a wide range of goals, including decreasing the risks of audit and improving their ability to attract and retain talented researchers, technicians, and engineers.

In this post, we will explore the many benefits of rapid micro methods and how QC Directors and Managers can start realizing those benefits now and not at some distant point in the future.

Why the Lag in Adoption of Rapid Micro Methods?

When labs first began exploring rapid bio methods, the big push was for rapid sterility testing due, which could significantly reduce incubation periods. This time-saving approach reduced the need for warehouse space used to house product until its release. For a time, cost-avoidance was enough to convince accountants they would see a return on investment. But in recent years, accountants have asked labs to be more specific about where those cost savings are coming from and whose budget should be reduced when the rapid method is implemented. This has made it more difficult for some companies to consistently claim a substantial ROI. 

For many companies, the pursuit of cost-reduction from rapid micro methods ended there, because they did not have sufficient evidence of other efficiencies that would justify their use. Yet, the reality is that there are many ways to de-risk lab processes and drive operational efficiencies through the use of rapid methods.

Following are several examples of how today’s rapid micro methods can provide significant and demonstrable value to your QC lab, enabling you and your team to stay on the leading-edge of research and discovery.

1) Automation of Sample Handling Can Reduce Risks, Time and/or Sample Waste

Manual processes create more variables than automated processes, and these variables can lead to errors and waste. For instance, when using viability-based air samplers or in-line water samplers, it takes time for microbiologists to physically carry media to the areas where they collect the samples and then return them to the laboratory for testing. Other growth-based systems also require that samples be taken to the sampling area, sampling performed, and the samples taken back to the laboratory for testing.

Rapid micro methods easily outperform these systems in terms of efficiency and accuracy. With an automated system, samples are scanned (logged into the system) and placed into the automated system as soon as they are received in the lab. The machine performs all of the handling until the results are recorded and the samples are either discarded or taken for additional investigative testing. In this scenario, it is highly unlikely that the samples will be mishandled, misidentified, or lost, although manual handling is still required for additional testing or discarding of the samples.

2) Standardization of Reading Results Prevents Errors

A common concern of QC Managers is differences exist in results based on who reviewed the samples and counted the plates or reported results for tubes. If ten people count the same plates, it is likely you may have ten different results posted. To manage these discrepancies, it is useful to have control charts or other mechanisms to track and monitor the differences in results based upon who read the results. But a chart will not solve the underlying problem, which is human error.

When computer-aided vision systems count results, you can always rely on getting the same count for each sample counted. It is also possible for the automated system to assess whether the colony count is a result of colonies merging or taking over other colonies. This eliminates the stress and confusion caused by different operators delivering varying counts.

3) Consistency Reduces Data Integrity Issues

In recent years, companies have been indicating to regulatory investigators that unless two or more individuals count the plates, the numbers may not be accurate. This is a challenge for everyone, but especially microbiologists who must ensure that the counts are accurate.

An automated system that counts plates using computer-aided vision systems always counts the plates the same way within the validated discrimination parameters. This means that every count is accurate every time, so results can be consistently reported and traced. When dealing with something as important as QC, settling for anything less than this level of accuracy can be dangerous.

4) Reporting Results Are Not Subject to Human Mathematical and Transcription Errors

When monitoring results are obtained, they frequently need to be converted to account for dilutions, reporting results in standard units, or performing averages. Each of these calculations is an opportunity to make a mistake. There is both the possibility of a mathematical error during the calculation as well as errors that occur when the data is transferred to the report.

Automated systems eliminate these types of human errors and ensure that the results are always calculated correctly. Additionally, the system accurately transfers the raw data to the report without the danger of transcription errors. Hundreds of hours of labor can be saved by eliminating the need to double- or triple-check calculations and data summaries for accuracy.

5) Automation Delivers Shorter Time to Results

Shortening time to results isn’t just a matter of convenience. Compiling and verifying that all the required calculations and reports have been generated accurately can cause significant delays in product release. Getting results sooner minimizes the risk to product as it moves towards release and gets product to market faster.

As you consider the efficiency and accuracy of your current approach, you may want to weight the pros and cons of Rapid Methods, Alternative Methods, and Automated Methods. Understanding what these terms mean and how they differ will help make that process easier.

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Have a technical question on rapid, alternative or automated micro methods? Contact David Jones, Director of Technical Marketing and Government Affairs here.

How can Rapid Micro Biosystems support your lab optimization needs? Contact us here

Article in collaboration with Jeanne Moldenhauer, Excellent Pharma Consulting, Inc.