Rapid Implementation of Rapid Microbial 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.

Ironically, these perceived barriers to QC micro labs validating an RMM instrument are the root cause issues that rapid microbial methods help remove.

The pharmaceutical, biotech, and medical device industries have long wanted suppliers to not only sell a rapid microbial detection platform but support its implementation from purchase all the way to routine use. In other words, provide a complete solution to handle the burden of validation.

To answer this need, Charles River created 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.

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Celsis Complete Validation Reports & Testing Service

The Celsis Complete Validation Support package harnesses the full power of Charles River’s extensive portfolio, internal expertise, and global capabilities. We have simplified the validation process to provide a complete, ready for regulatory submission validation data set in less than 120 days—reducing the burden on organizations seeking to implement a rapid microbial detection platform.
 

Celsis complete chart


How Does the Celsis Complete Validation Package Work?

Using this validation service, Charles River Microbial Solutions will begin the process by sending you the following documentation:

  • Celsis Method Equivalency Validation Report
  • Celsis Robustness Verification Technical Report
  • Celsis Ruggedness Verification Technical Report
  • Celsis 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 Charles River’s 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 report will be prepared by Charles River Laboratories. This report will be reviewed, finalized, and submitted to you to be integrated into your prepared regulatory documentation for submission.

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  • Definitive Rapid Sterility Validation Data

    Using this validation service, Charles River Microbial Solutions will begin the process by sending you the following documentation:

    • Celsis Method Equivalency Validation Report
    • Celsis Robustness Verification Technical Report
    • Celsis Ruggedness Verification Technical Report
    • Celsis Sample Effects protocol
  • Key Benefits of Celsis Complete Validation Support
    • Decreases implementation time by eliminating the need to demonstrate method equivalency to the compendial method
    • Reduces the need and costs attributed to personnel, resources, and time to validation
    • Speeds implementation of Celsis rapid sterility applications through its regulatory submission-ready datasets
    • Enables personnel to focus on other aspects of the validation process
  • Product Information
    Product Name
    Product Code
    Celsis® Complete, Sterility Service & Reports, Membrane Filtration 

    VAL6000MF