INSIGHTS ON QUALITY CONTROL
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Seamlessly Integrating An E-WorkBook With A Customer's LIMS
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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Contamination Control Strategy With QRM Principles
Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.
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Method Migration Of A Normal Phase HPLC Method For Tocopherols
The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.
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Human Performance In Pharma: Strengthening The Biotech Workforce
Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.
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Manufacturing Solutions3/4/2025
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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Effective Staffing Plans For GMP Drug Manufacturing Facilities8/12/2024
In the manufacturing industry, the proper planning and staffing of GMP facilities and production lines are crucial for efficient operations and successful outcomes.
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Aseptic Expertise And Delivery Of Services8/20/2024
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Vial Breakage During Lyophilization: Root Causes And Mitigation10/16/2024
Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing5/7/2024
The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
QUALITY CONTROL SOLUTIONS
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The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.
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Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.
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The FMS-Water Activity Analyzer is a non-destructive gas analyzer for making water activity measurements of solid dosage drug product samples.
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In the pharmaceutical industry, microbiological monitoring and testing is highly regulated and complex. Discover how to optimize your QC lab's workflow and ensure compliance with proven services.
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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.