INSIGHTS ON QUALITY CONTROL
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Webinar On-Demand: Substitution Of Hazardous Substances
Substitution is the essential starting point in every risk assessment. Learn how to conduct a legally compliant substitution check using real substances as examples.
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Mitigate Human Error And Improve Performance In Pharma QC
Gain insight into how the Quality Control team at Almac Sciences developed processes and strategies to help ensure a high quality of safe and effective products while also maximizing efficiency.
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Key Strategies For MES Software Integrations
To stay competitive in an increasingly dynamic field, pharma and biotech manufacturers are implementing numerous beneficial technologies to automate and streamline production. Explore the power of MES integration.
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Host Cell Impurities, Bioassays, Micro-Flow Imaging
Ensuring the safety and efficacy of cutting-edge biopharmaceuticals hinges on meticulous quality control measures. Explore the role of qPCR and MFI in safeguarding drugs from potential contamination.
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Understanding The Hidden Value Of Quality6/26/2023
Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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DSC Characterization Of Crystalline Structure: Apparent Melting5/5/2023
Here, we compare theory and results for thermodynamic and apparent melting and explain why it is important to distinguish between them when interpreting results from DSC.
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2023 Pharmaceutical Quality Trends1/11/2023
The world has changed dramatically in recent years, exposing vulnerabilities in supply chains, quality assurance, and other concerns. Explore how quality leaders are tackling pharma disruptions and more.
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Characterization Of Amorphous Pharmaceuticals By DSC Analysis4/11/2023
Here, we will explore how to quantify the glass transition temperature of an amorphous pharmaceutical solid through the use of Differential Scanning Calorimetry (DSC) and Modulated DSC.
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The Roles Of Operational Readiness, Capital Projects In Drug Manufacturing8/31/2022
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
QUALITY CONTROL SOLUTIONS
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Performing endotoxin testing? Trust your data with a Monocyte Activation Test that mimics the human immune reaction and detects both endotoxins and non-endotoxin pyrogens.
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Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So, it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.
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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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Three media, Friis, Frey, and Hayflick, are used to detect different ranges of mycoplasmas. MilliporeSigma offers all three as ready-to-use, with longer shelf-life broth and plates for compendial testing.
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The Integra uses the same proven three spinning roller sealing head design as the standard PW Westcapper®. Now, a servo driven actuator will bring the sealing head to the vial and utilize a load cell to accurately provide proper sealing pressure. This functionality provides a quality seal despite variations in vial height.