INSIGHTS ON QUALITY CONTROL
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Advancing Cell Therapy Manufacturing: Rapid Sterility Testing
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>.
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Effect Of X-Ray Inspection On Pharmaceutical Products
Explore the use of X-ray inspection systems for the internal examination of pharmaceutical products, particularly non-transparent packaged drugs.
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Accelerate Biologics Product Release With Seamless Viral Testing
Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.
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Data Intelligence Requires An Intelligent, Data-Driven Approach To Digital Transformation
An intelligent and data-driven digital transformation is the key to data intelligence. Discover how in 5 simple steps.
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China11/11/2024
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Strategic CMC Planning Through A Phase-Appropriate Quality Approach5/28/2024
A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.
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Building A Connected Quality And Manufacturing Ecosystem In Life Sciences12/27/2024
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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The Role Of Quality By Design In Pharmaceutical Tablet Development7/30/2024
Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.
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Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres12/30/2024
Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.
QUALITY CONTROL SOLUTIONS
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Advantech Sonic Sifter Powder Weighing and Transfer Enclosure designed to provide personnel protection during compacting and coating operations involving Highly Potent Active Pharmaceutical Ingredients (HPAPI).
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This intuitive and reliable HPLC system supports First Time Quality (FTQ) by reducing the risk of common errors and improving the accuracy of analytical measurements.
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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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The X2 and X6 Packaged X-ray Inspection Series enhance safety by detecting contaminants and improving product quality with advanced technologies, supporting productivity, compliance, and brand protection.
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Discover a 21 CFR Part 11-compliant digital validation platform designed for conducting IQ & OQ on your microbial QC testing systems dedicated to bioburden testing, sterility testing, and air monitoring.