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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

  • 3P® CONNECT

    EM-body Connectivity

    3P® CONNECT is a software that secures sample traceability, reduces errors, and supervises environmental monitoring data in real time for greater process efficiency.

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  • 3P® ENTERPRISE

    EM-Power the Future

    3P® ENTERPRISE delivers a full workflow automation with real‑time oversight, data integrity, and cross‑site harmonization to boost efficiency in environmental monitoring programs.

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  • AIR IDEAL® 3P®

    Bring Confidence to your Environmental Monitoring

    AIR IDEAL® 3P® is used for the detection of viable organisms through active air sampling.

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  • API®

    Manual Microbial Identification

    API® makes microbial identification simple and reliable. Combining a standardized method with an extensive and robust digital microbial ID knowledge base, API® can easily be implemented into any microbiology laboratory.

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  • 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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  • BIOBALL® Standardized Strains

    Take Control of Your Microbiological QC

    BIOBALL® enables food manufacturers to strengthen microbiological quality control with highly accurate, ready‑to‑use reference strains simplifying workflows and saving valuable time.

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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. 

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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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