What's Your RMM Validation Strategy?

As the adoption of rapid microbial detection methods continues to increase, it's more important than ever that vendors become more than just instrument suppliers. They need to become partners: an organization to work alongside you every step of the way, supporting your alternative method. Not just at the point of sale at a single location, but all the way to routine use globally.

Many labs have realized that the regulatory landscape has shifted when it comes to implementing rapid microbial methods (RMMs): organizations now have access to more guidance, resources, and support by regulatory agencies and thus no longer have to rely on their own internal staff to handle all aspects of a validation project.

Although in-house expertise forms the foundation of a strong RMM validation strategy, most labs still struggle with the planning, scheduling, and execution of implementation activities and often feel overburdened with the amount of testing and added workload.

Complete RMM Validation Solutions

Realizing the need for better knowledge of the alternative method, we have harnessed our expertise and capabilities across divisions of Charles River to address it. Using our Biologics division, and our multi-accredited testing facility in Ballina, Ireland, we have begun commissioning full Celsis® equivalency validation testing for various applications in order to provide this data for customers seeking to implement Celsis® rapid microbial detection in their labs.

  • Celsis® Sterility Equivalency (Membrane Filtration) – Report

    Finalized in collaboration with a leading pharmaceutical manufacturer, this Celsis® equivalency validation report for membrane filtration is provided in a regulatory-ready format for submission by customers seeking to implement a rapid sterility.

    This report demonstrates the equivalence of the Celsis AMPiScreen® rapid microbial method after 6 days’ incubation to the compendial sterility test method after 14 days’ incubation for the qualitative screening of a pharmaceutical product for microbial contamination, as described in USP <71>, Ph. Eur 2.6.1, and JP 4.06. As part of the equivalency study, the limit of detection (LOD) and specificity were also demonstrated.

  • Benefits of the Celsis® Equivalency Validation Report
    • Decreases implementation time by eliminating the need to demonstrate equivalency to the compendial method
       
    • Reduces the need and costs attributable to personnel, resources, and time to validation
       
    • Speeds implementation of Celsis® rapid microbial detection for sterility via its regulatory submission-ready dataset 
       
    • Enables personnel to focus on other aspects of the validation process
  • Download the Celsis® Equivalency Report Product Sheet

    To Learn More Details On:

    • Test Methods & Materials Utilized
    • Testing Location and Conditions
    • Challenge Organisms Tested
    • Number of Replicates Tested
    • Statistical Analysis Methods Employed
    • Conclusions on Equivalency, Limit of Detection, and Specificity

  • Product Details
    Product: The Celsis® Sterility Equivalency (Membrane Filtration) – Report
    Product Code: VAL4000EQ
    Format:
    • Delivered on purchase as an individually licensed PDF 
    • Hard-copy print version available upon request 
    Report Contents:
    • Test methods & materials Utilized 
    • Statistical analysis and explanation of methods employed
    • All raw data and Celsis® instrument workload reports
    • Definitive conclusion on Equivalency, Limit of Detection, and Specificity

     

The True Cost of RMM Validation

  • Method Validation Timeline

    Typically, even an experienced validation team can spend 6-12 months proving the performance and functional equivalence of the alternative method without the presence of their product. While time is most often the most visible factor to most labs validating a rapid microbial detection method, labs must also consider cost.

    While in-house testing should be performed in order to ensure working knowledge with the alternative method, the instrument supplier can provide solutions to reduce the time and cost between installation and routine use.

  • Method Validation Material Costs

    The additional costs for performing equivalency validation have a significant impact on both the overall capital expense of implementation of an RMM, but are often not fully considered. A lab should address costs concerning:

    • Technical staff and personnel resources in the project planning, authoring of protocols, execution of testing, results analysis, and report writing
       
    • Reagent and consumable costs required by the rapid microbial method system
       
    • Test materials, including growth media, commercially available organism preparations, or in-house isolates.
       
    • It is not unreasonable for a lab to consider these costs down to sterile pipette tips. Although these seem trivial since they are used so routinely, a single case of 1,000 tips can cost approximately $75 – $100. This can equate to several thousand dollars in pipette tips alone when considering how many tips can be used in preparing and executing over 500 samples in duplicate, and preparing cultures, dilutions, transfers, and controls.
       
    • Equipment allocation and usage with respect to current, routine laboratory testing.

     

    Typically, it is safe to also account for an additional 20% added cost for potential re-work. Since equivalency is typically performed first, a lab group should account for invalid tests due to inexperience with the new rapid system.