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SMARTER QUALITY MONITORING

Traditional Sterile Pharma

Choosing the right microbiology diagnostic solution can simplify workflows and boost efficiency for routine testing. Adding automation can increase standardization, reduce human error, and increase data integrity. Implementing rapid and simple at-line testing of key parameters provides certainty that your manufacturing process is secure.

Rapid and Simple At-Line Testing

Rapid quality control release testing can help you get therapies to patients who need them quickly and safely, and with the most comprehensive portfolio of efficient solutions for microbial quality control of sterile drugs, we can help.

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® ENTERPRISE

    Em-power the Future

    Bridging the gap between standard processes and automation, 3P® ENTERPRISE transforms the future of environmental monitoring in the pharmaceutical industry. From sampling to trending, take control with an end-to-end, fully digitalized and automated workflow. Increase efficiency and ensure your products are safe and compliant with an innovative environmental monitoring system.
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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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  • 3P® Support & Services

    Your Vision, Our Mission

    As your partner, we’re committed to providing you with the assistance and services you need to make implementation easier and faster.
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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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  • 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™

    Better for your lab. Better for the planet.

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

ENVIRONMENTAL MONITORING FOR PHARMACEUTICALS

In microbiology and pharmaceutical development, environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection. Data comes from samples of air, surfaces, and personnel in a clean space.

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IDENTIFYING MICROBIAL CONTAMINATION IN PHARMACEUTICAL MANUFACTURING

Sterile and non-sterile pharmaceutical products should be free of harmful microbial species. The financial impact of microbial contamination during the manufacturing process can be significant, from large volume product loss to product recalls.

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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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