The benefits of implementing rapid microbiological methods in the pharmaceutical industry are numerous and go beyond just a faster time-to-result. Rapid microbiology eliminates days from your standard assay time or follow-up investigations, delivering the critical information needed to maintain control of your production process. Some rapid microbial methods also help achieve higher data integrity by eliminating the subjectivity associated with visual methods of microbial analysis. Some technologies provide lab automation benefits by reducing the risk of human error in setup, testing, and analysis. Furthermore, the advantages of an RMM platform, such as a Celsis® instrument, can extend across a company by reducing inventory requirements and production cycle times, shrinking warehousing and working capital requirements, and improving overall profitability through lean manufacturing.
We understand there are many factors to consider when selecting an RMM and have outlined the following steps to help you.
1. Define Your Needs for a Rapid Microbial Method
Many labs mistakenly concentrate on which of the rapid microbiological methods might appear to be the most used in the industry, rather than focus their selection process on which RMM will be best for their needs and products.
When considering a rapid microbial method, labs should first identify the key drivers and requirements that are most important to their workflow and business. These requirements, such as sample compatibility, vendor expertise, and ease of implementation, can vary from company to company, and even from within a company from site to site. Armed with this knowledge, your team can evaluate which rapid microbiological methods search criteria, and ultimately, which RMM can meet your requirements.
In order to guide customers and help them identify viable options, we’ve created a document to use while determining which rapid microbiological methods will work best for them.
2. Understand the Costs of Rapid Microbiology
Many labs are intimidated by the initial capital costs of investing in a rapid method of microbial analysis by comparing it to current or traditional methods. It is not a secret that when it comes to technology, new will cost more than old or none at all. However, QC labs, along with their site management, should assess the long-term return on investment (ROI) of a rapid microbial method by considering the operational and functional benefits of a faster time to result. These include analyzing factors such as cost-per-test, inventory carrying costs, contamination rates, and resource requirements.
We can help you determine the five-year ROI of implementing an RMM using data from your current methods and production process through our Financial Impact Assessment tool.
3. Understand the Rules for Rapid Microbiological Methods in the Pharmaceutical Industry
In addition to meeting internal business, product, and user requirements, labs must identify the appropriate regulatory or government requirements that all rapid microbial methods must fulfill. Below, you will find globally recognized guidance documents for rapid microbiological methods in the pharmaceutical industry that should be understood and followed during this process.
As a global leader in quality control solutions, Charles River has implemented and supported the use of rapid microbial methods across the world and can assist you in understanding what you need to be compliant.
4. Evaluate Your Options
Often, the evaluation phase seems the most daunting when selecting a rapid microbiology solution. Many rapid microbiological method seekers do not consider evaluating rapid micro methods in terms of a total platform, but mistakenly view each technology with a focus solely on the instrument and detection method. While understanding the fundamentals of the technology are important, they do not provide much in the way of selection criteria. Current rapid microbiology technology instruments can be broken down by whether they are qualitative or quantitative and by detection technology in the following manner:
Quantitative Rapid Microbiological Methods
Qualitative Rapid Microbiological Methods
The more effective approach is to consider the microbiology equipment suppliers' options for consumables, compatibility with different media types, and additional benefits such as automation or data integrity compliance.
If you've successfully identified your rapid microbial method needs in Step 1, you should have a firm understanding of your key requirements, as these play a critical role in this phase. By evaluating a rapid microbiological method as a platform rather than an instrument, you can now evaluate an RMM as one that can meet your needs, such as compatibility with multiple samples across your manufacturing process in the future, or its ability to automate certain processes to allow scalability for increased lab throughput.
Here are a few resources that provide clear, easy-to-digest assessments of the current market for rapid microbial methods available:
To help in your evaluation and comparison of on-market alternative rapid microbiological methods, Charles River has created an editable PDF worksheet to help. It was created using common evaluation criteria, as recommended in BioPhorum’s ARMM Framework article. It has been pre-populated with information on how Celsis® compares, with open fields to input information on other rapid microbiological platforms that you may be evaluating.
5. Plan Your Rapid Microbiological Method Implementation Strategy
When selecting a rapid microbiological method in the pharmaceutical industry, implementation and validation is often considered the biggest obstacle in the path to adoption. Many prospective companies believe that the qualification and validation approach must be novel and unique to their business, requiring advanced statistics. However, as an industry, successful labs are willing to share and present on their approach, their validation method, and outcomes when it came to validating their own rapid microbiology system.
Charles River has presented the work of two industry thought leaders to help contribute and educate our customers and those looking to bring a rapid method into their lab.
Charles River Microbial Solutions also provides a unique solution for companies planning to implement a rapid microbiological method for sterility testing. In order to speed the implementation phase, reduce resource demand, and make the process more efficient, we now offer a ready-to-use report for equivalency validation via membrane filtration. This method is compliant with USP <71>, Eu.Ph 2.6.1, as well as other pharmaceutical industry guidance documents.
6. Start the Rapid Microbiological Method Buying Process
Armed with these resources and a greater understanding of how to begin selecting the right microbial method for your organization, it’s time to start the process. Begin by reaching out to selected suppliers and engage with them, ask questions, and determine the best path forward.
Our team can work with you and your team to determine the best path forward to implementing a rapid microbiological method specific to your product, your method, and your lab.