INSIGHTS ON QUALITY CONTROL
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![Milliflex Oasis Filtration System Funnel Open]( "Comparative Study On Secondary Contamination Risk")
Comparative Study On Secondary Contamination RiskAccurate testing results are crucial for product safety. Explore the findings of a comparative study evaluating two different platforms for the membrane filtration of microorganisms in quality control.
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![Thermo - 7-16 webinar]( "Tackling Residual DNA Testing In Biotherapy Manufacturing")
Tackling Residual DNA Testing In Biotherapy ManufacturingControlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
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![iStock-941351188-lab-cleanroom-sterile]( "Advancing Cell Therapy Manufacturing: Rapid Sterility Testing")
Advancing Cell Therapy Manufacturing: Rapid Sterility TestingThe 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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![GettyImages-1392303980-chromatography-LC]( "HPLC Autosampler Performance I: Challenging USP Methods")
HPLC Autosampler Performance I: Challenging USP MethodsIn this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.
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Essential Insights Into Pharmaceutical Product Release, Part 1 Of 212/27/2024
Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.
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Building Control Strategies: It's Time To Go Digital1/24/2025
Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.
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Accelerate Your R&D And QC With These 3 Key Analysis Methods5/4/2024
Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.
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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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Water Activity And Primary Packaging For Oral Solid Dose Products7/10/2024
The draft of the general chapter USP<922> says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.
QUALITY CONTROL SOLUTIONS
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![Vented Balance Safety Enclosure]( "Vented Balance Safety Enclosure")
For use in pharmaceutical, chemical, biological, and toxicological laboratory settings. Specifically designed to provide maximum containment for balance applications. The opening of the enclosure has uniquely designed acrylic airfoils that allow a smooth turbulence-free airflow that prevents balance fluctuation. Weigh down to 5 places without fluctuations or loss of product. The work surface is black for easy powder detection, constructed of tough, chemically resistant phenolic resin, and has a dished bottom for containing spills. Enclosures feature an ergonomic, energy efficient design with angled front for worker comfort.
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![Corporate Brochure visual 8]( "Trusted End-To-End CDMO Partner For Your Journey")
In an increasingly competitive environment, working with the right CDMO is vital for successful drug lifecycle management. We now serve more than half of the world’s leading biopharmaceutical companies, sharing their mission to expedite patient access to life-saving biologics.
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![Pall]( "Palltronic® Flowstar V Integrity Test Instrument")
Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.
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![Data Analytics Strategy]( "Feasibility Studies For Container Closure Integrity Testing Applications")
PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
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![Milliflex System Feature]( "Rapid System For The Early Detection Of Microbial Contamination")
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.
