Sterility Testing: An Essential Part Of Pharmaceutical Product Validation
To effectively monitor product quality, it is critical to test for microbial contamination throughout the pharmaceutical manufacturing process. Sterility testing is a vital step to ensure products purporting to be sterile do not contain viable microorganisms prior to their distribution and administration to patients. Consequently, it is of utmost importance that the testing method employed for products, formulations, tissue materials, and medical devices is both accurate and reliable. Explore a collection of streamlined sterility testing solutions and expert guidance on sterility testing, quality control (QC), and data integrity. Optimize your sterility testing and QC procedures with world-leading tools and technologies that can help you ensure full traceability and regulatory compliance.
INDUSTRY INSIGHTS
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Explore trends and challenges in microbiology QC with Anne Weeks, a senior field marketing manager at MilliporeSigma. She discusses workflow automation in QC testing and introduces a customizable MTR solution.
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Join product and application experts Anne-Grit Klees, Carine Krebs, and Esther Welterlin to discover the benefits of using the new rapid microbial detection platform, Milliflex® Rapid System 2.0.
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Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.
SOLUTIONS
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Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and compliance with contemporaneous, automatic, and complete recording of testing data.
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Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.
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Discover the Milliflex® Rapid System 2.0, an automated solution for the rapid detection, imaging, and quantification of viable microbial contaminants in filterable samples throughout the manufacturing process.
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Read about MilliporeSigma's extensive portfolio of technologies for membrane filtration-based sterility testing in cleanrooms, laminar flow hoods, biosafety cabinets, and isolators.
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Explore a wide variety of devices, pumps, and sterile culture media and rinsing fluids that can help you to ensure compliance, whether you use membrane filtration or direct inoculation methods.