INSIGHTS ON QUALITY CONTROL
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Detection And Quantification Of Amorphous Content In Materials
Complementary analytical techniques like DSC, MDSC, cRHp, DVS, and SolCal accurately quantify amorphous content in pharmaceuticals to ensure stability, compatibility, and efficiency.
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CDMO Audit Coverage: Key Focus Areas And Compliance Objectives
CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.
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Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance
Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.
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Building A Connected Quality And Manufacturing Ecosystem In Life Sciences
Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.
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A Powerful Non-Destructive Tool For Tablet Characterization10/6/2025
Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.
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Deploying A Modern HPLC For Biopharma Analysis In QC Environments4/16/2024
Explore findings from a study evaluating the performance of a modern HPLC system in comparison to a legacy system in a routine QC testing environment for biopharmaceuticals.
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Data Integrity In The Quality Control Lab: No Pen, No Pain12/10/2024
Data integrity in pharmaceutical QC labs is critical for product safety. This webinar explores digital solutions to improve traceability, reduce paperwork, and enhance workflows.
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Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification11/24/2025
Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.
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Leveraging A Modern HPLC System For Peptide Drug Substances Analysis8/22/2024
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
QUALITY CONTROL SOLUTIONS
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A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).
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Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
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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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The Milliflex® Rapid System 2.0 brings together membrane filtration and ATP bioluminescence to detect, image and quantify microcolonies of bacteria, molds and yeasts up to 4 times faster than compendial bioburden or sterility testing methods.
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Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and regulatory compliance with contemporaneous, automatic, and complete recording of QC testing data.