Sterility Validation Without the Headache

How RMB supports you through every step of your validation journey

For many pharma and biotech manufacturers, the decision to switch to rapid sterility testing is a no-brainer—until the word “validation” enters the conversation.

The benefits of switching to rapid sterility testing are clear:

• Faster result turnaround.
• Reduced batch release times.
• Streamlined workflows.

But for some, the roadblock isn’t the technology itself—it’s the validation process.

Validation can feel daunting, especially when it appears to demand significant internal resources, specialist expertise, extensive documentation, and a deep understanding of regulatory expectations. The prospect of hiring an army of third-party consultants or stretching in-house teams just to get started can make the transition feel overwhelming.

But you don’t have to go it alone. At Rapid Micro Biosystems (RMB), we have designed our validation approach to take the hard work out of the process, providing everything you need—from expert guidance and skilled validation personnel to resourcing and fully compliant documentation—to facilitate a smooth and successful validation journey.

Read on to explore RMB’s approach to validation, and how we work alongside our customers to achieve a successful validation.

Explore the economic case for adopting rapid sterility testing

How we support you with your validation journey

When it comes to implementing a new sterility testing system, validation is often the most resource-intensive part of the process. That’s why we have built a comprehensive, hands-on sterility validation support model around the Growth Direct® Rapid Sterility System (GDRS).

End-to-end validation support that works like an extension of your team:

• Stepwise validation pathway – RMB’s experts guide you through a structured, step-by-step validation process tailored specifically for sterility testing.
• Dedicated validation personnel – Skilled RMB team members work alongside your internal teams to execute validation activities efficiently.
• Complete regulatory documentation – RMB provides all necessary validation documentation, ready for regulatory submission and inspection.

Our sterility validation approach exceeds industry standards, enabling your sterility testing processes to meet the highest level of compliance and performance. Unlike generic validation templates or “one-size-fits-all” services, the RMB validation approach is fully customized to your product types, workflows and resource capacity. Our support model reflects the real-world challenges faced by QC labs—and is rooted in our collective team’s decades of microbiological and regulatory expertise.

Additionally, RMB brings an extensive library of primary validation data. This helps minimize the amount of redundant testing required at your site, saving time and resources while still maintaining confidence in the method's performance.

By combining expert guidance, pre-developed materials and embedded technical support, we empower labs to adopt rapid sterility testing while minimizing disruption and added burden—turning a typically daunting process into a smooth and highly supported experience.

A sterility validation process built for confident regulatory submissions

When transitioning to a new sterility testing method, regulatory compliance is a top concern. Our validation framework is designed to align with global regulations, enabling your lab to meet the necessary requirements for submission without the guesswork.

GDRS validation follows the standards outlined in:

• USP <1223> – Validation of Alternative Microbiological Methods: Provides a scientific and risk-based framework for validating new technologies to replace or supplement compendial methods.
• EP 5.1.6 – Alternative Methods for Control of Microbiological Quality: Offers guidance for assessing equivalency and suitability of rapid or alternative methods in the European context.
• PDA Technical Report 33 – Evaluation, Validation, and Implementation of New Microbiological Testing Methods: A detailed roadmap for designing and executing validation studies, including acceptance criteria and risk management approaches.

RMB bases every stage of its validation process on these standards to enable your sterility testing system to pass regulatory review—whether you're preparing for an FDA submission or aligning with EU GMP expectations. The validation documentation provided eliminates the need to reverse-engineer protocols or justify study designs retroactively.

You don’t need to interpret the regulatory language or worry about what’s “good enough”—we’ve already done the heavy lifting, so you can move forward knowing your validation is grounded in globally accepted best practices.

Equivalence testing performance criteria

Equivalence testing is a critical validation step to confirm that GDRS performs as well or better than the traditional compendial method. Our compliance-focused sterility validation process rigorously evaluates conformity with all critical equivalence testing parameters, including:

• Specificity – Ability to detect target microorganisms accurately.
• Time to Detection (TTD) & Time to Result (TTR) – Ensuring faster detection without compromising accuracy.
• Limit of Detection (LOD) – Sensitivity levels that match or exceed compendial sterility tests.
• Method Suitability – Validation across different sample types, including challenging or inhibitory formulations.

With pre-existing validation data and regulatory-aligned protocols, RMB reduces the need for redundant on-site testing, helping you accelerate your validation timeline.

The GDRS sterility validation roadmap

Validation doesn’t have to be complex. We’re here to support you at every stage of our validation roadmap to ensure a seamless transition to rapid sterility testing:

1. Installation & Operational Qualification (IOQ) – Verifies that the system is installed and configured correctly, and that all critical hardware and software components operate according to specification.

2. Performance Qualification (PQ) – Demonstrates that the system reliably detects a broad panel of microorganisms, including USP- and EP-specified challenge organisms and relevant environmental isolates, confirming consistent and repeatable detection across the three-cassette media format.

3. Method Validation – Confirms that the GDRS rapid sterility method is suitable for detecting microbial growth within a 7-day assay window. This includes establishing the system's Time to Detection (TTD) and Time to Result (TTR) for slow-growing organisms

4. Equivalency & Limit of Detection (LOD) Testing – Validates that the GDRS method performs equivalently to the compendial sterility test by comparing detection rates at low inoculum levels (e.g. 1–10 CFU) and confirming acceptable LOD thresholds through statistical analysis.

5. Method Suitability Testing – Evaluates the interaction between your specific sample matrices and the GDRS method, ensuring that any product interference is mitigated and that the system performs reliably across real-world formulations.

This structured approach to sterility testing validation is both efficient and fully compliant in order to minimize the risk of delays or regulatory hurdles.

RMB does the heavy lifting—so you don’t have to

If you’ve been holding off on switching to rapid sterility testing because validation seems too complicated, RMB is here to help. With a proven validation framework, hands-on expert support, and pre-developed validation data, we provide everything you need to move forward with confidence.

Ready to see how validation could look at your facility? Contact us today to start the conversation and simplify your transition to rapid sterility testing.