Complete Implementation of Rapid Microbiological Methods
Validation of rapid microbiological methods is a regulatory requirement that takes a considerable amount of time (typically 6–20 months) and internal resources to perform. This investment is often seen as a barrier to implementation for many quality control microbiology laboratories lacking the bandwidth, internal expertise, and resources to complete it on their own.
These obstacles can now be avoided by validating with an RMM instrument. Many industries, such as pharmaceuticals, biotech, and medical devices, not only want to leverage a rapid microbial detection platform, but also require support throughout the cycle, thereby entirely removing the burden of validation. To address this need, we have built a robust RMM validation service package that delivers regulatory-required validation data, along with cGMP testing performed on behalf of customers by our expert laboratories.
"During our evaluation of rapid sterility systems, we found that Charles River’s Celsis system outperformed other commercially available options for RMM. The system aligns closely with compendial expectations and —being a growth-based method— provides greater assurance of product safety. The Charles River team was instrumental in supporting us throughout every stage of qualification and implementation. Their collaborative approach ensured a smooth and effective transition to the new system.”
Vinod Patel, Sr Vice President, Troikaa Pharmaceuticals Ltd.
Explore the Celsis® Rapid Microbial Detection Brochure
Gain insight into Celsis® technologies, platform capabilities, implementation considerations, validation support, and microbial detection applications across a range of product types.
Access the Brochure
How Does the Celsis Complete Validation Package Work?
We begin the process by sending you all of the essential validation documentation, such as:
- Method Equivalency Validation Report
- Robustness Verification Technical Report
- Ruggedness Verification Technical Report
- Sample Effects Protocol
Once delivered, your organization can begin the internal documentation preparation process for final regulatory submission and provide suitable lots of sample product to be validated by our Biologics Testing Solutions laboratory. In parallel, your QC lab can perform the technology transfer, and continue to prepare its regulatory submission while awaiting the final delivered testing data.
Once testing in presence of your product is completed, a final method validation report is prepared. This report will be reviewed, finalized, and submitted to you for integration into your regulatory documentation for submission.
Product Name |
Celsis® Complete, Sterility Service & Reports |
Celsis® Complete Validation Reports & Testing Service
The Celsis Complete Validation Support package harnesses the full power of our extensive portfolio, internal expertise, and global capabilities. We have simplified the method validation process to provide a complete, ready-for-regulatory-submission validation data set in less than 120 days.
Rapid Microbial Methods for Contract Testing Laboratories
Modernize your lab with an advanced, ultra-fast automated solution that detects microbiological contamination in just 7 days for rapid sterility, and less than 2 days for microbial limits.