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ENSURE STERILITY EFFICIENTLY

Sterility Testing

Whether you’re releasing time-sensitive personalized medicines or manufacturing products with longer production cycles, rapid sterility testing is critical to ensure patient safety. We provide safe, proven, and efficient sterility testing solutions for rapid answers.

Rapid Results for In-Process and Release Testing

Our technologies are specifically designed to speed up detection times and we provide turnkey validation services to help you implement our method more quickly. Our validation protocols comply with international pharmacopoeia standards and our support is fully customizable, providing everything from validation templates to on-site personalized solutions.

Product List

  • BACT/ALERT® 3D

    The BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing.

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  • BACT/ALERT® Culture Media Bottles

    The BACT/ALERT® Culture Media Bottles, used in conjunction with the BACT/ALERT® 3D or BACT/ALERT® VIRTUO®, offer advantages across every dimension of microbial testing.

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  • CHEMUNEX® D-COUNT Rapid Microbial Detection

    The CHEMUNEX® D-COUNT system is an advanced analysis solution for the rapid detection of microorganisms.

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  • Feasibility Study

    A feasibility study is probably the single most important consideration when it comes to changing your method of application. Saving you time, resources, and energy, it’s a vital aspect of ensuring compatibility.

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  • Pharmaceutical Culture Media

    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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  • SCANRDI®

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

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  • Validation Protocols

    Managing validation plans across multiple facilities is nothing less than an art form. Whether you are implementing in-process testing solutions within your laboratory or on your production floor, you can rest assured that with ourvalidation services, all regulatory standards of local and international pharmacopeias will be fully upheld.

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Resources

BUILD OUT YOUR BIOPROCESS TESTING WORKFLOW

Bioprocessing is a type of manufacturing that uses living cells to produce a product. In pharmaceutical bioprocessing, a living cell is manipulated to manufacture the drug of interest in bioreactors and is then purified and formulated to create the end product.

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ON-DEMAND: BACT/ALERT® 3D: FROM ALTERNATIVE TO ROUTINE FOR TESTING CELL AND GENE THERAPY PRODUCTS

Listen to Lori Daane, Sr. Director of Scientific Affairs at bioMérieux, discuss rapid sterility testing within the cell and gene therapy landscape. She discusses the evolving regulations and why the BACT/ALERT® has continued to be the go-to instrument of choice for testing these products for microbial contamination.

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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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