INSIGHTS ON QUALITY CONTROL
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Evaluation Of Novel Process Indicators For Hydrogen Peroxide Decontamination
Immediate, quantifiable verification replaces seven-day incubation periods. Discover how enzyme-based indicators optimize hydrogen peroxide decontamination.
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Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation
Maintaining high-purity water is vital for pharmaceutical production. Explore key strategies for system design, risk mitigation, and rigorous process control to ensure consistent regulatory compliance.
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Audit-Ready EAM/CMMS Records
Maintenance and calibration records hold up under review only when executed work, changes, attachments, and exceptions travel together. Rehearsing retrieval shows whether an export carries the context another person needs.
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The Art And Science Of Getting Tech Transfer Right First Time
Technology transfer connects drug development to scalable manufacturing through early engagement, open knowledge sharing, and data-driven methods like Design of Experiments to safely advance therapies.
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Tackling Residual DNA Testing In Biotherapy Manufacturing7/16/2025
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
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PDA TR33 And The Case For Rapid Methods In H₂O₂ Bio-Decontamination10/14/2026
The updated 2026 PDA Technical Report No. 33 offers a framework for qualifying alternative and rapid microbiological methods against traditional standards for regulatory compliance.
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What Is LearnGxP?4/24/2026
Stop the cycle of "click-through coma" in GXP training. Discover how scenario-based learning and role-specific curricula reduce compliance risks and drive meaningful engagement.
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The Strategic Value Of In-House Delumping For Homogeneous API Production9/9/2026
API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.
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Is Your Water Undermining Your Results?10/15/2026
Water is often chosen by availability rather than application. Defining it as a controlled process parameter targets a variability source that routinely escapes root cause analysis.
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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Explore an extensive analytical chemistry and microbial testing compliant portfolio for pharmaceutical analysis and quality control (QC) from early-stage drug development to product release.
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Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.
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Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.
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Discover how Cambrex can reliably develop and manufacture a broad spectrum of HPAPIs and compounds.