Fast-Tracking RMM Validation
When implementing a rapid microbiological method, validation testing is performed to meet regulatory requirements to ensure non-inferiority to the traditional test method. Validation, as a whole phase, can take laboratories between 6-20 months, depending on their internal resources, experience, and bandwidth. The overall time can vary dramatically from the initial estimates due to a variety of reasons, including incorrectly written procedures, the unanticipated need to include additional replicates, and repeat assays due to invalid tests based on user error.
The validation process must be planned and reviewed, and documentation, such as protocols and reports, must also be written. Many labs perceive this as an insurmountable barrier to implementation, even though solutions exist to overcome these obstacles. Ironically, these perceived barriers, preventing QC Micro labs from validating an RMM instrument, are the root cause issue that rapid microbial methods help remove.
The pharmaceutical, biotech, and medical device industries have been waiting for a solution to the burden of validation that has suppliers not only selling a rapid microbial detection platform but supporting its implementation all the way to routine use. To answer this need, Charles River has created a robust RMM validation documentation package that delivers the regulatory-required validation data along with CGMP test protocols authored by our expert staff and statisticians.
Celsis® Advantage Validation Reports & Protocols
The Celsis® Advantage Validation Support package utilizes Charles River’s expertise in microbiological validation to provide the scientific protocols, documentation, and reports to fast-track validation. We have simplified the validation process to provide a comprehensive method validation data set for equivalency, specificity, and limit of detection, along with all the necessary testing protocols to perform additional method suitability, equivalency, specificity, and limit of detection testing in presence of product.
How Does the Celsis® Advantage Validation Package Work?
Using this rapid microbiology validation support pack, Charles River Microbial Solutions will send you all of the essential validation documentation: Celsis Method Equivalency Validation Report, Celsis Robustness Verification Technical Report, Celsis Ruggedness Verification Technical Report, along with ready-to-use testing protocols for Celsis Sample Effects, and method suitability testing for equivalency, limit of detection, and specificity in presence of product.
Once received, your laboratory is ready to begin validation testing using these protocols or can adapt them to suit any special in-house sample preparation methods. In parallel, you can also begin to prepare your regulatory submission package using our validation reports, while method suitability testing is performed.
Once your method suitability testing is completed, just include your testing reports and submit your documentation package to the appropriate regulatory agencies.
Definitive Rapid Sterility Validation Data
Upon final receipt of all testing reports and documentation, the comprehensive documentation set will include:
- All test methods and tested materials used or necessary for validation testing
- Statistical analyses and explanation of methods employed
- Celsis instrument workload reports and raw data
- Definitive conclusions on non-inferiority of the Celsis method for equivalency, limit of detection, and specificity via Celsis Equivalency Report for sterility via membrane filtration
- An easy-to-use set of test protocols for method suitability and sample effects testing
Key Benefits of Celsis® Advantage Validation Support
- Decreases implementation time by eliminating the need to demonstrate method equivalency to the compendial method
- Reduces the time required to plan, author, and approve testing protocols for method suitability testing
- Speeds implementation of Celsis rapid sterility applications through its regulatory submission-ready datasets and test-ready protocols
- Enables personnel to focus on other aspects of the validation process and decreases the need for internal expertise in validation, statistics, and protocol writing
Celsis® Advantage, Sterility Reports & Protocols, Membrane Filtration
Frequently Asked Questions About the Celsis Advantage Rapid Sterility Test Validation Support Package
How is this different than the Celsis® Complete Validation Package?
The Celsis Advantage only differs from the Celsis Complete package in that this bundle provides method suitability protocols for testing in presence of product to be performed in your lab, rather than full testing services outsourced to Charles River Laboratories. Both packages include the same validation reports for equivalency, specificity, and limit of detection (not in presence of product), as well as sample effects testing protocols.
The Celsis Advantage validation package offers testing using vetted, prescribed test methods to labs that may have the experience in performing microbiology testing but not in validation planning. It also provides a lower cost alternative in initial purchase pricing.
However, it will require additional costs for personnel, resources, and materials to perform the necessary testing, and these may vary due to uncontrollable internal issues, such as retests or scheduling. In contrast, the Celsis Complete validation package provides all of the testing performed by Charles River, at a fixed cost and predetermined schedule.