The first two steps in our validation series have looked at the differences between validation for alternative and growth-based RMM technologies, as well as the specific requirements for the installation and operational qualification of the Growth DirectTM System. Continuing the series, the next steps in the validation of the Growth Direct™ System is Performance Qualification (PQ), Time to Results Qualification and Method Suitability. Rapid Micro Biosystems' Technical Services team and documentation support help make the process run as smoothly and efficiently as possible.
While the IOQ verifies that equipment is installed correctly and that all components are operating according to specification, the performance qualification (PQ) process validates the Growth DirectTM System against accuracy and precision according to guidelines in USP<16> and USP<1227>, with USP defined test organisms and organisms of interest using the Growth Direct™ System and the control (traditional) method. During this time, automated tests are run on the Growth Direct™ System in tandem with traditional tests. It is recommended that three different operators perform counts to assure accuracy in the comparison to the Growth DirectTM System results. Finally, the results are statistically compared for equivalence.
Time to Results Qualification
Once performance qualification is completed, the testing lab next determines the optimal time to detection specific to their application. An analysis of microorganism detection times on the Growth Direct™ System will yield a point where organism counts plateau. Using this data, the time to result is identified and is typically about half the time of the traditional method.
At the conclusion of IOQ and PQ, method suitability testing is performed using the new time to results. Whereas PQ tests accuracy and precision for a variety of standard microorganisms, this phase tests the specific product matrices to verify that there are no inherent characteristics that will affect detection. In the case of the Growth Direct™ System, these would be characteristics that affect the ability of the system to see a clear image such as a fluorescent background.
Spike and recovery testing is performed according to USP Chapter <61>, USP Chapter <1227>, and EP Chapter 2.6.12, as per the traditional culture test with three lots of product and using <100 CFU of the Pharmacopoeial specified microorganisms and any environmental isolates that may be relevant. Most manufacturers will test several “families” of samples to minimize the overall testing volume but achieve applicable results.
Standardization, Repeatability and Ongoing Support
Companies that successfully navigate the validation process have found the following guidelines to be of value:
- Creating a center of excellence for RMM operations
- Developing centralized validation protocols
- Creating a knowledge and technology transfer process from one facility to the next
- Standardizing as many processes as possible
- Including technology literature such as peer-reviewed documents, customer testimonials, etc. along with validation documents in the technology dossier
- Taking advantage of vendor expertise
Timeframes and Training
While many variables can impact the timeline for validation, the PQ process can typically start a few weeks after installation. The Rapid Micro Biosystems Technical Services team has years of validation experience and readily available validation documents that can be leveraged to streamline the validation process.
Because of its similarity to the traditional culture method, the validation of growth-based RMM equipment can be less complicated, and can be accomplished more rapidly than validation of some other technologies. With the Growth DirectTM System, users also gain the support of experienced personnel for installation, training, documentation and even ongoing assistance once implementation is complete.
Discover how the Growth DirectTM System can streamline your microbiological tests by simply downloading this comprehensive guide, which outlines the benefits of automated microbial enumeration.