Seamless Implementation Powered by RMB Application Services

Implementing a new rapid microbial detection system doesn’t have to be complex. At Rapid Micro Biosystems, we make it seamless.

Our Application Services specialists provide the microbiology expertise and scientific support you need to move confidently from evaluation to implementation of the Growth Direct^® System. Whatever your application, our team delivers methods and documentation that informs your buying decisions and allows you to seamlessly implement the Growth Direct® System.

Whether you need to confirm product compatibility or develop a new method from the ground up, our Application Services team partners with you to ensure your testing needs are met and fully aligned with the relevant GMP and pharmacopeial frameworks—including those recognized by the FDA and EMA. This additional layer of support helps to make your Growth Direct implementation efficient and backed by data you can trust.

Read on to discover how our application services combine decades of industry expertise and close collaboration to simplify rapid microbial detection implementation and ensure full compliance.

Simplifying implementation through proven expertise 

Our Application Services are designed to make your Growth Direct implementation straightforward from the start. They combine two core offerings: Feasibility Studies and Method Development, to help you confirm product compatibility, optimize methods, and generate data that’s ready for validation.

Rather than leaving you to navigate complex technical and documentation requirements alone, our microbiologists act as an extension of your team. They perform detailed compatibility and method suitability work—assessing how your products, rinse types, and any required challenge microorganisms interact within the Growth Direct System—and translate those findings into clear, actionable data packages to support validation.

This partnership-driven approach reduces implementation risks, increases adoption rate, and ensures every parameter is tested and documented by experts who understand both the science and the standards.

And because every lab is different, our services extend across all Growth Direct® applications—environmental monitoring, bioburden, water, and rapid sterility testing—so you can rely on consistent, compliant performance wherever you apply the system.

Feasibility Studies 

Before purchasing or implementing the Growth Direct System, it’s natural to want evidence that Growth Direct can reliably analyze your products, rinse fluids, and sample types without interference—and produce accurate, reproducible results. That’s exactly what a feasibility study provides.

As the first stage of our Application Services, feasibility studies are short, pre-purchase evaluations designed to confirm product compatibility, growth promotion, and method suitability.

Simply send us your samples, and we’ll perform the feasibility analysis on them in one of our state-of-the-art microbiology laboratories based in Lexington, MA, and Freising, Germany — giving you the convenience of regional access and the assurance of consistent, expert-led results.

Each study includes:

• Product compatibility testing – to check for potential interference with the Growth Direct System.
• Growth Promotion – if you have unique microorganisms, we will perform growth promotion on our media to ensure we have the right incubation temperature and durations.
• Method suitability – to verify that microorganisms recovered and enumerated accurately in the presence of your product.

A typical study runs for four to six weeks and concludes with a detailed final report containing results and recommendations. These findings can be used to support validation activities later on—reducing your internal workload, strengthening documentation that regulatory bodies recognize, and giving you data-backed confidence to move forward.

Method development 

Our Method Development services are designed for situations where no established method exists—or where feasibility testing reveals that your current approach would benefit from optimization.

Working with your product samples, our microbiologists adjust and refine test parameters to establish a reliable, compliant procedure for use on the Growth Direct System. This includes defining challenge microorganisms, optimizing incubation conditions, and confirming accurate recovery and time-to detection (TTD) or time-to-result (TTR) performance. The process ensures that even complex matrices, such as cosmetics, cell-based therapies, or radiopharmaceuticals, can be tested on the Growth Direct System.

Typical projects take about three months from protocol approval to final report. The deliverables includes a complete, method development protocol and documented data you can use as the foundation for your internal validation activities, giving you a proven method from day one.

Explore our approach to sterility testing validation in our blog “Sterility Validation Without the Headache”

Beyond testing: partnership you can trust 

Implementing new technology in a regulated environment becomes a whole lot easier when you have a partner who understands the science, the standards, and the expectations of validation reviewers. That’s why our Application Services are built with collaboration at their core.

From the first feasibility study through to full method development, you’ll work directly with RMB microbiologists who understand the challenges of bringing rapid microbial detection into GMP workflows. Our experts translate complex results into clear, defensible documentation that supports your validation and satisfies regulatory expectations, whatever your product or testing needs.

This partnership approach gives you more than a result: it gives you a roadmap for successful implementation and long-term confidence in your new testing method. By combining scientific depth with validation-ready data, RMB helps you accelerate validation, reduce implementation risks, and approach every regulatory conversation knowing your methods are backed by proven expertise and industry-leading support.

Your seamless path to implementation

Implementing a new rapid microbial detection system doesn’t have to be complicated — and with our Application Services, it isn’t. You gain direct access to RMB’s microbiology and method validation experts, giving you the scientific backing and documentation needed to move smoothly from evaluation to implementation.

Whether you’re validating a novel biologic, optimizing workflows for complex formulations, or simply looking to streamline your path to automation, our team is here to make every step clear, compliant, and defensible.

When you’re ready to implement with confidence, we’ll help you get there. Faster, smarter, and with data you can stand behind.

Looking to simplify your path to implementation? Contact us today to explore how our Validation Services could help you.