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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

   

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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