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503A Compounding, 503B Outsourcing, and Hospital Pharmacies

Microbiological quality control is a critical step in developing and releasing compounded or customized medications. Every step in the process helps ensure treatments are safe for patients. While essential, it can be labor-intensive and time-consuming, sometimes requiring days to receive results.

That’s where our solutions come in. From sterility results in as little as four hours to MALDI-TOF identification and smarter, more sustainable endotoxin testing, we offer a comprehensive portfolio of rapid microbiology solutions designed to improve efficiency—enabling faster batch releases and a more reliable supply.

Microbiological Quality Control Solutions for Compounding Pharmacies and Hospital Pharmacy Operations

With demand for customized medications continuing to grow, compounding pharmacies have a unique opportunity to capitalize. A streamlined, automated quality control workflow that delivers fast, accurate results can be a key differentiator.

Whether you’re looking for increased speed, enhanced sterility assurance, greater regulatory confidence, scalability—or all of the above—bioMérieux has you covered.

Our Microbiological Quality Control Solutions

  • SCANRDI®

    Rapid Microbial Detection and Enumeration

    SCANRDI® revolutionized rapid microbial detection when it was first introduced and still today its speed and sensitivity remain unrivaled.

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  • ENDONEXT™

    The Evolution of Endotoxin Testing

    ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.

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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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  • 3P® CONNECT SOFTWARE

    Em-body Connectivity

    3P® CONNECT is designed to secure sample traceability and collection of your Environmental Monitoring (EM) data to ensure reliable decision-making and optimize process efficiency. This comprehensive system includes dedicated software and  performant pre-barcoded 3P® SMART PLATES. Skipping the traditional paper-based process for EM decreases risk of errors and saves time during the entire production process.

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Partner With bioMérieux To Increase QC Efficiency 

Want to enable compliance confidence and faster batch releases?

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 microbiological quality control testing. 

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

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Validation and Successful Implementation of SCANRDI

CASE STUDY

Validation and Successful Implementation of SCANRDI®

This case study outlines the process Atlas Analytical used to demonstrate that the SCANRDI® technology is qualified for determining the sterility of test samples.

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ARTICLE

Single vs. Dual Temperature Incubation in Environmental Monitoring

Single temperature incubation is less commonly used in environmental monitoring today — but that’s starting to change. This article explores how the right strategy and tools can help your program shift to a single temperature approach for greater efficiency, simplicity, and risk reduction.

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EBOOK

Your Quick Guide To Better Endotoxin Testing

Most new users of Limulus-based tests want to review basic knowledge around endotoxin and endotoxin detection, while more experienced users want to review the practical aspects of testing with an eye toward meeting ever-changing regulatory expectations. They also want to generate laboratory dialog as to how to apply basic principles and “best practices” to increasingly complex tasks including method development, verification, validation and the routine testing of various drug types. This material can also serve as a supplement to a user’s basic endotoxin training.
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