Whereas strict protocols are helpful in providing clear guidelines and requirements for testing, they can also act as a barrier of new microbiological detection techniques.
But the barriers are weakening and the market is shifting more towards a risk based – ‘quality by design’ – approach. Miller is an expert in pharmaceutical microbiology and the design implementation and validation of (new) rapid microbial methods.
These types of studies can also be performed in the event the RMM supplier has little or no data on testing similar product or test materials.
This can be accomplished using a rental or loaner instrument, or by sending samples directly to the supplier for evaluation.
Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.
The following sections provide an overview of how to design a meaningful validation program in order to effectively demonstrate that the new RMM is equivalent to, or better than, the existing method you intend to replace.
The recent release of the newly revised PDA Technical Report 33, “Evaluation, Validation and Implementation of New Microbiological Testing Methods,” is an excellent resource for detailed guidance on preparing the business to implement and validate a rapid method.
Automated, growth-based methods such as The Growth Direct System allow users to automate the tasks they already perform by hand, streamlining their existing workflows and cutting out a great deal of hands-on work.
He is the editor of PDA's Encyclopedia of Rapid Microbiological Methods, is co-chairing the revision of PDA Technical Report No. Companies find that in-house training is the most cost-effective means to improve the skills and capabilities of their employees.
These types of methods can be classified as “automated compendial,” since they simply automate the existing method and provide results in colony forming units (CFUs).
In contrast, some alternative RMM technologies involve entirely new processes and additional steps.
From a scientific perspective, it is important to understand what technical capabilities are required, including, but not limited to, method sensitivity and specificity (e.g., detection levels and for what types of microorganisms), sample throughput, sample type, automation, data handling and archiving, report management, if the system needs to meet 21 CFR Part 11 expectations, and the required degree of operator training.
Proof-of-concept or feasibility testing can also be performed to determine if incompatibilities exist between the RMM and the intended product or test sample(s).