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GROWTH DIRECT BROCHURE

Learn about the important advantages Growth Direct offers your facility

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    Feasibility Studies and Method Development

    RMB Application Services provide the compatibility data, optimized methods, and documentation required to move from early evaluation to the implementation of the Growth Direct System.

    Our Application Services give you the scientific evidence and expert guidance you need to implement the Growth Direct® System with confidence.

     

    Through feasibility and method development studies performed in our Lexington, MA and Freising, Germany laboratories, we generate the compatibility data, optimized methods, and documentation that de-risk your project and accelerate your path to automation.

     

    Aligned with GMP and key pharmacopeial expectations, our support gives you clear answers, defensible data, and a smoother, faster implementation—so you can move forward with certainty.

     

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    EARLY DATA THAT SUPPORTS CONFIDENT ADOPTION OF THE GROWTH DIRECT® SYSTEM

    Feasibility Studies

    Feasibility Studies provide initial technical confirmation that products, rinse fluids, and sample matrices can be evaluated on the Growth Direct System. Testing is performed in Rapid Micro Biosystems laboratories in Lexington and Freising under controlled conditions.

     

    Rapid Micro Biosystems microbiologists examine how each sample type behaves within the automated detection process. This includes assessment of potential matrix effects, recovery characteristics, and overall method suitability.

    Feasibility Testing includes

    • Product compatibility studies to evaluate potential interference
    • Growth promotion testing for challenge microorganisms
    • Method suitability assessments to verify accurate recovery and enumeration
    • A complete study report with data, interpretation, and recommendations

    Most feasibility studies are completed within four to six weeks. The resulting data provide early technical justification and support internal planning for method validation.

    OPTIMIZED METHODS DESIGNED FOR RELIABLE VALIDATION

    Method Development

    Method Development is recommended when a method does not exist or when feasibility results indicate that refinement is necessary. The objective is to establish a reliable, compliant method for use with the Growth Direct System.

     

    Rapid Micro Biosystems microbiologists work directly with customer samples to develop method parameters that support consistent and accurate microbial recovery. This process is particularly important for complex matrices such as biologics, cosmetic formulations, radiopharmaceuticals, and advanced therapy medicinal products.

    Method Development includes

    • Optimization of incubation conditions and detection parameters
    • Selection and justification of challenge organisms
    • Confirmation of recovery characteristics and time to detection or time to result
    • A complete method development protocol
    • A final report suitable for initiating internal validation

    Most method development projects require approximately three months from protocol approval to completion. The outcome is a method that can be advanced directly into internal qualification activities.

    Frequently Asked Questions

    RMB provides a sample submission checklist that outlines the required details, including product information, expected bioburden levels, organism lists, handling instructions, and shipping guidance.


    The study begins once the required method information, product details, and challenge microorganisms are provided. 

     

    Yes. Our Application Services routinely support: cell-based therapies, radiopharmaceuticals, cosmetic formulations, advanced formulations, and other matrices that require method refinement.


    Method development can be tailored to your specific product and testing needs.
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