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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.

Solutions

  • BIOBALL® Custom Services

    BIOBALL® Custom Services help you simplify the implementation of microbial strains within your routine microbiological quality control process.

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  • BIOFIRE® Mycoplasma

    1-Hour Mycoplasma Testing by Anyone, Anywhere, Anytime

    BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.

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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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  • ENDONEXT™ Automated with Tecan

    Unlocking Lab Efficiency with Automated Endotoxin Testing

    ENDONEXT rFC-based endotoxin testing solutions are now fully automated on the Tecan Fluent® platform to optimize manufacturing processes.

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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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  • 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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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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