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INCREASE EFFICIENCY WITH FASTER STERILITY RESULTS

Sterility Testing

Whether you’re releasing time-sensitive personalized medicines or manufacturing products with longer production cycles, rapid sterility testing is critical in helping ensure patient safety while enabling faster product release.

We provide safe, proven, and efficient sterility testing solutions that cut traditional sterility testing time and even provide same-shift results.

Rapid Results for In-Process and Release Testing

Sterility testing is often one of the last steps in ensuring a drug product is safe to be released to patients. With traditional growth-based methods, it can be anywhere up to 14 days before these critical sterility results are ready, which can cause loss of momentum when demand is high or add unnecessary delays for life-saving medicines. 

Rapid Microbiological Methods (RMMs) can significantly reduce time required for sterility testing, while maintaining accuracy and reliability. Our SCANRDI® technology enables same-shift results in just 4 hours, while our BACT/ALERT® 3D solution automates previously manual steps and is trusted by more than 80% of CAR-T Therapies manufacturers.

Rapid microbiological testing technologies are specifically designed to speed up detection times and we provide turnkey validation services to help you implement our method. Our validation protocols comply with international pharmacopoeia standards and our support is fully customizable, providing everything from validation templates to on-site personalized solutions.

Our Sterility Testing Offering

  • BACT/ALERT® 3D

    The Method of Choice for Rapid Sterility Testing

    BACT/ALERT® 3D - used by more than 80% of the top 20 big pharma companies to release pharmaceutical products, delivering fast results through a simple, efficient sterility testing workflow.

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  • CULTURE MEDIA For Sterility Testing

    BRING RELIABILITY TO YOUR RELEASE CONTROLS

    Detecting contaminants is a critical step for the release of sterile pharmaceuticals.

    Effective and reliable culture media will allow for the detection of any possible contaminant in your products, ensuring patient safety.

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  • Media Fill Testing

    A New Version on the Media Fill Test

    We bring a new dimension to the media fill test with a Tryptic Soy Broth (TSB) containing a color indicator that changes from pink to yellow if your filled unit is contaminated so you can feel confident in your production process.

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  • SCANRDI®

    Rapid Microbial Detection and Enumeration

    SCANRDI® offers ultra-rapid microbiological detection of bacteria, yeasts, and molds in 4 hours or less with universal cell labeling and solid-phase cytometry.

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  • SCANRDI® CELL-BURST

    Same-shift sterility testing for cell & gene therapies

    Removing sterility testing as a bottleneck, the CELL-BURST Solution completes the SCANRDI® system and provides an ultra-rapid method to enable earlier release and accelerate patient access to life-saving therapies. 

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Partner With bioMérieux For Fast, Accurate Sterility Testing

Our rapid sterility testing solutions support pharmaceutical manufacturers, compounding facilities, and advanced therapy developers seeking faster microbiological results without compromising compliance.

Want more details? Complete the form below to get in touch with our team. A bioMérieux expert will be in touch using the contact information you provide. By providing your information, you agree to receive additional emails from bioMérieux about sterility testing. 

To find out more about the management of your personal data and to exercise your rights, see our privacy policy. 

Continue Your Journey

rapid sterility testing using bact alert 3D

CASE STUDY

How a Top 5 Pharma Company Enhances Production Efficiency through Rapid In-Process Testing

A top 5 pharmaceutical company incorporated automated, rapid sterlity testing using BACT/ALERT® 3D. Their approach was designed to detect any microbial contamination at the earliest possible opportunity and has been key in maintaining control over their production processes.

EXPLORE
Ultra-Rapid Microbial Detection in Cell and Gene Therapy Products

POSTER

Ultra Rapid Microbial Detection in Cell and Gene Therapy Products

In this study, the Most Probable Number (MPN) was used to demonstrate that the LoD of the SCANRDI® CELL-BURST is not significantly different from the LoD of a traditional plate counting method on 10 compendial strains. To show the equivalency, the proportion of positive results was compared between both methods for all strains and all dilutions with a non-inferiority test of Farrington-Manning, with a 20% margin.

GET THE DATA
Non-Growth Based Alternative Sterility Testing

WHITE PAPER

Non-Growth Based Alternative Sterility Testing

This white paper addresses the appropriate response to an out-of-specification sterility test when using a non-growth-based rapid microbial method such as the SCANRDI® system that utilizes solid phase cytometry.

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