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Real-World Use Cases of Automated, Growth-Based RMM: Implementing Company-Wide RMM Validation Standards

Written by Rapid Micro Biosystems | Jul 29, 2014 11:30:00 AM

As the pharmaceutical industry embraces lean initiatives in quality control (QC), labs are finding the validation of new processes and techniques to be one of the most involved tasks in implementing new methods. The implementation of rapid microbial methods (RMM) requires validation that the new method is equivalent to the current traditional test. 

For large manufacturers, RMM validation can seem overwhelming at first, particularly when processes can vary from one facility to the next. However, the similarity between automated, growth-based RMM and the compendial method makes validation a more straightforward process compared to the validation of alternative methods. By creating company-wide implementation standards, even the largest manufacturers can streamline this process as they install automated, growth-based technologies throughout their different facilities.

Thus far we've discussed RMM use cases in streamlining microbial testing, better utilizing resources, and accelerating the cleanup process between small batch runs. Today we'll cover a few best practices in establishing company-wide standards for the implementation of automated, growth-based RMM.

The Challenge

Many multinational pharmaceutical companies face a common problem as they implement new QC processes and technologies. Multiple worldwide facilities use a variety of microbial testing methods, and inconsistencies often arise in operating procedures and reporting. It becomes difficult for disparate QC teams to compare results or implement standard operating procedures. When implementing rapid methods, these inconsistencies may lead to more complicated and costly validation projects, adding effort to implementing any new system throughout the enterprise.

The Solution

To standardize procedures and provide for more streamlined validation of new microbial methods, large manufacturers can begin by installing an automated, growth-based technology such as the Growth DirectTM System at a single flagship facility, or center of excellence,  for a specific method or methods—water and bioburden testing, environmental monitoring or the sterility testing of finished products.

With the aid of the system's vendor, the QC and QA personnel can build the validation documents as well as create the standard processes for assessing its comparability to the manual method for colony enumeration. This process also allows facilities to ensure the system's accuracy and precision are acceptable according to regulatory guidelines. Having completed the validation process, the content created can be used to establish company-wide standards for the future validation of the same technologies at different sites worldwide.

The Results

Validation time frames can vary between specific RMM systems and from one company to the next, but the use of global validation standards can streamline the process following an initial implementation. A reduction in validation time can allow other facilities to spend less time and resources on duplicate processes, and it potentially makes it easier for sites that have already installed the technology to expand its use. Overall, global implementation standards can help large, forward-thinking companies to take advantage of the benefits of automated, growth-based RMM.

To learn more about how—and why—you should consider adding rapid methods to your lab, check out other companies' successes with RMM in our most recent eBook, “Practical Applications for Automated Rapid Methods in Pharmaceutical Quality Control.”