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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

    Monitoring quality in microbiology is critical and challenging for pharmaceutical companies. ​While hand transcription remains the standard procedure in use, these daily processes often rhyme with errors leading to time-consuming investigations, and not fully compliant data.​

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  • 3P® ENTERPRISE

    Environmental monitoring (EM) is the main microbiological control performed by pharmaceutical industries. While multiple hand-written and transcription operations remain the standard procedure in use for thousands of samples per month, the daily processes often result in errors leading to time-consuming investigations, low value-added tasks and data that is not fully compliant. As a result: major impacts on batch release, on process efficiency and ultimately patient safety.

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  • 3P® Environmental Monitoring Culture Media

    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

    The 3P® legacy is one of delivering proven performance when it comes to effective pharmaceutical contamination control. Now it’s going digital.

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  • AIR IDEAL® 3P®

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

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  • API® 

    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

    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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  • ENDONEXT™

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

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  • ENDOXPERTS™

    The phenomenon of Low Endotoxin Recovery (LER) has gained renewed attention in the scientific community in recent years as the FDA now requires that all new Biological License Applications are able to successfully unmask when LER occurs. ENDOXPERTS™ is our solution for unmasking LER, which helps you meet regulatory requirements.

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  • ENDOZYME® II GO STRIPS

    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

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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