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FASTER RELEASE TO MARKET

Compounding Pharmacy

Speed and quality are paramount in the Compounding Pharmacy Market. Knowing your product is free of contamination allows for faster release to market, giving you greater flexibility to respond to changes in demand and gives you a competitive advantage in the market.

Fast, Accurate Diagnostic Solutions

With a comprehensive range of diagnostic solutions, we deliver accurate and fast results you need to protect your consumers and your brand.

Our newsletter, The Compounding Pharmacy Insider, is a valuable resource for professionals in the 503B compounding pharmacy industry. Learn more and join our growing community here.

Product List

  • 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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  • 3P® Environmental Monitoring Culture Media

    Bringing Confidence to Your Environmental Monitoring

    Accurate and reliable environmental monitoring solutions will bring you confidence when making product release decisions, allowing you to protect your product and your patients.
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  • 3P® SMART PLATES

    Em-brace Traceability

    When conducting routine microbial surveillance of pharmaceutical manufacturing facilities, accuracy can empower you to make smarter decisions, meaning products, employees, and patients remain safe, and your business operates in compliance with regulatory guidelines. When it comes to Environmental Monitoring (EM), state-of-the-art culture media is a necessity when you’re counting on traceability and definitive results.

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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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  • BIOBALL® Standardized Strains

    Microbiological Quality Control

    BIOBALL® is a small water-soluble ball containing a precise number of microorganisms that delivers accuracy and precision, batch after batch.

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  • BIOBALL® Custom Services

    BIOBALL® Custom Services helps you simplify the implementation of microbial strains of your interest in the routine microbiological quality control.

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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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  • 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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Resources

Selkirk Pharma Implements 3P® ENTERPRISE To Streamline Environmental Monitoring Processes

Selkirk Pharma is a U.S. based contract manufacturing organization specializing in the sterile fill and finish of injectable drugs, including vaccines and biological therapies. Their state-of-the-art facility in Spokane, Washington boasts cutting-edge technology and recently completed the implementation of 3P® ENTERPRISE. 

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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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VALIDATION AND SUCCESSFUL IMPLEMENTATION OF SCANRDI®

While rapid microbiological methods (RMM) have been in common use by the food, health, and beauty aid industries for decades, the more highly regulated pharmaceutical industry has been slower to adopt them. The FDA supports RMMs for drug testing, as long as these alternative methods are validated to demonstrate their equivalency to the compendial methods.

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CANDIDA ALBICANS: HOW IT AFFECTS THE PHARMACEUTICAL INDUSTRY

Candida albicans is an opportunistic pathogenic yeast1 and a common member of human gut flora. It is usually a commensal organism, but it can become pathogenic in immunocompromised individuals under certain conditions.

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