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SMARTER QUALITY MONITORING

Traditional Sterile Pharma

Choosing the right microbiology diagnostic solution can simplify workflows and boost efficiency for routine testing. Adding automation can increase standardization, reduce human error, and increase data integrity. Implementing rapid and simple at-line testing of key parameters provides certainty that your manufacturing process is secure.

Rapid and Simple At-Line Testing

Rapid quality control release testing can help you get therapies to patients who need them quickly and safely, and with the most comprehensive portfolio of efficient solutions for microbial quality control of sterile drugs, we can help.

Product List

  • ENDONEXT™ Automated with Tecan

    We have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform. 

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  • ENDOXPERTS™ Services

    Comprehensive Endotoxin Services with a Special Focus on Low Endotoxin Recovery (LER)

    ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER. Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. 

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  • ENDOZYME® II GO STRIPS

    Flexible Endotoxin Testing

    Laboratories don’t always need to test all 20 samples to fill a full plate—that’s why ENDOZYME® II GO STRIPS are designed with flexibility in mind: the flexibility to use only what you need, when you need it.

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  • Instrument Service Plans and Support

    Maximize the Uptime of your Instruments. Ensure Continuous Operations.

    Regular maintenance means more reliable and stable systems that reduce downtime, increase efficiency, and improve the performance of your equipment. Our goal is to provide the service you need, when you need it. In order to achieve this, we’ve developed a range of service packages tailored to laboratories of all sizes.
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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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  • PREVI® COLOR GRAM

    Automated Gram Staining

    PREVI® COLOR GRAM is a fully automated stain process from fixation to drying that uses our patented spray technology to provide rapid, standardized results for all specimen types.
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  • Pharmaceutical Culture Media

    Comprehensive Control

    Reliable culture media solutions safeguard pharmaceutical products from contamination, making them an integral part of microbiology QC testing. Production of our culture media follows rigorous quality control procedures, from formula development to validated performance.
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  • VILINK® Instrument Management System        

    Instrument Management System

    VILINK® software is our real-time support system that keeps the instruments in your laboratory running via remote monitoring.

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  • VITEK EXPRESS Identification Services

    ID Services Powered by Microbiology Experts

    As microbiologists, we know fast and reliable results are of the utmost importance. Get the accurate identifications you need quickly and easily.
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  • VITEK® 2 COMPACT

    Your Solution for Automated Microbial Identification

    The VITEK® 2 Compact system offers quality control testing solutions for fast and accurate microbial identification. With technology that includes an extensive and robust identification database, rapid results, and minimal training time, it will streamline laboratory workflow for increased productivity.
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Resources

ENVIRONMENTAL MONITORING FOR PHARMACEUTICALS

In microbiology and pharmaceutical development, environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection. Data comes from samples of air, surfaces, and personnel in a clean space.

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IDENTIFYING MICROBIAL CONTAMINATION IN PHARMACEUTICAL MANUFACTURING

Sterile and non-sterile pharmaceutical products should be free of harmful microbial species. The financial impact of microbial contamination during the manufacturing process can be significant, from large volume product loss to product recalls.

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NON-GROWTH BASED ALTERNATIVE STERILITY TESTING

This technical brief 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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