Rapid microbiological methods (RMM) are becoming more common in the pharmaceutical industry, replacing the time-tested yet inefficient traditional method. Still, concerns regarding validation, resources and new methods have left many businesses wary of the technology.
However, the benefits of rapid methods far outweigh the concerns and most can be easily addressed. The following are responses to five common objections to RMM technologies:
- Method Varies Too Much from the Traditional Test
Some RMM technologies require new processes for the lab. In certain cases, these new processes involve the use of reagents that can destroy the samples, making identification more complicated. However, not all rapid solutions are the same. While many technologies require significant changes to the current sample process, other methods simply automate the existing assay while preserving growing colonies for identification. Growth-based systems, such as Growth DirectTM use familiar growth media and sample preparation techniques and require minimal training for employees already familiar with traditional methods.
- Validation Concerns
A common concern of rapid methods is the complexity to validate or the perception that regulatory agencies are not open to the use of rapid methods. Manufacturers have been using the compendial method for more than 100 years and regulators have experience with the technique. The perception is that the validation struggles outweigh the benefits.
While validation is never a simple process, it is clear through the successful validation of several methods that regulatory authorities are open to the new methods. With the recent update to the TR33 document, methods that are considered “automated compendial” require a less stringent set of activities for validation, which can streamline the process.
- Time and Money
Businesses often have concerns around the financial and human resources needed to install and validate a new technology in the lab. However, given the long-term savings and increases in efficiency that automated, growth-based RMMs can offer, companies can hardly afford not to take advantage of the technology. The ability to automate the incubation, enumeration and reporting of samples not only frees resources in the lab but positions the lab to handle increases in test volumes without increasing resources. The faster time to results allows manufacturers to produce larger volumes, ship faster and potentially reduce warehousing needs.
- Even Faster Results
Companies that compare different RMM systems will discover that each method offers a different time to results. The company must find a balance between the rapid time to result versus the effort that may be required in sample preparation or the additional steps associated with a positive result. With automated growth-based RMMs such as Growth DirectTM, results are available in about half the time of the compendial method. In addition, Growth DirectTM performs multiple sample reads, allowing for the detection of positives in hours. Moreover, because the test is non-destructive, the sample is available for identification.
- Vendor Support
Finally, a standard concern with any new technology is vendor support. Questions of concern often include: “Can the vendor provide documents and resources to help streamline the validation?” and “Will the vendor be available for any issues that arise?”
For companies considering the Growth DirectTM System, the dedicated Rapid Micro Biosystems team provides extensive support before, during and after the validation. From building the business case for the investment, to installation and validation, to ongoing support, the team at Rapid Micro Biosystems is here to support.
To learn more about the benefits of growth-based RMM, download this free guide today.