INSIGHTS ON QUALITY CONTROL
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Leachables Method Development, Validation And Relevant ICH References
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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The Importance Of Having A Strong Reject Characterization Program
Discover how linking inspection results to systematic defect analysis strengthens data integrity, accelerates root cause resolution, and satisfies regulatory process knowledge requirements.
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A Decision Focused Guide To Contamination Control From Design To Opening
Stop treating contamination control as a late-stage detail. Learn how making early, intentional design choices prevents startup delays and ensures your new cleanroom is ready for inspection.
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Manufacturing Solutions
Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.
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Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint2/12/2026
Achieving sterile excellence requires more than just rigid protocols. Learn how to foster a proactive mindset across your entire organization to ensure long-term facility integrity.
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The Problem With Construction Quality10/21/2024
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
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Seamlessly Integrating An E-WorkBook With A Customer's LIMS8/12/2024
Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.
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Digitalizing Pharma Control Strategies: A Roadmap1/24/2025
Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.
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The Pain Of Change – Could Suppliers Be Part Of The Cure?10/15/2024
Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
QUALITY CONTROL SOLUTIONS
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Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.
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TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.
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Real-time environmental monitoring can streamline QC workflows. Learn how continuous particle detection and advanced microbial sampling support proactive contamination control and data-driven oversight.
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To monitor product quality effectively, it’s critical to test for microbial contamination throughout manufacturing. Discover an easy-to-use, non-destructive, fluorescent staining-based system for faster microbial detection.
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The Esco IntelliGlove Tester (EIGT) is an advanced glove integrity testing solution designed for pharmaceutical, biocontainment, and aseptic manufacturing environments where consistency, traceability, and regulatory compliance are essential.