INSIGHTS ON QUALITY CONTROL
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0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?
Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
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Minimizing Particulate Risk
While visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.
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Development Of Separation Methods For GLP-1 Synthetic Peptides
Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.
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Contamination Control Strategies For Innovation And Regulatory Compliance
Creating a robust contamination control strategy is essential for pharmaceutical manufacturing. Learn to align risk management and technical controls to ensure lasting regulatory compliance.
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Monitoring, Media Fills, And QC: Demonstrating Sterility Assurance At Your CDMO2/13/2026
CDMO guide on environmental monitoring, media fills, and QC to prove sterility assurance in aseptic manufacturing—key elements of the Contamination Control Strategy beyond facility design.
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Improving Bioprocess Monitoring And Control With Multivariate Data Analysis12/9/2024
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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Thermal Analysis In The Pharmaceutical Industry12/30/2024
Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.
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Delving Into Gene Expression Data Analysis And Experimental Reproducibility3/5/2026
Scientific reproducibility is essential for credible research. Learn to navigate standardized frameworks, refine normalization techniques, and ensure your data remains transparent and verifiable.
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What Pharmacies Often Miss In USP <800> Compliance5/27/2026
Master USP <800> compliance by transitioning from standalone equipment to an integrated system design. Review key protocols for a multi-layered strategy to mitigate cumulative drug risks.
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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Grow and scale up your manufacturing with the right support, and choose from 92,000+ chemicals provided through an extensive global network of 3,500+ manufacturers.
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Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.
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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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What is dissolution testing? Why is it critical? What should you consider for your method validation? Find answers to these questions and more in this quick guide to dissolution testing.