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Case Study: Retrofitting Two New High-Purity Water SystemsThe existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
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Case Study: Retrofitting Two New High-Purity Water SystemsThe existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
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Case Study: Retrofitting Two New High-Purity Water SystemsThe existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
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Robotic Vial Filling and Capping Machine (RVFCM2) under isolatorRobotics and isolators are an increasingly popular combination in the pharmaceutical industry due to the rising number of high-value therapies, such as Cell and Gene Therapies.
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Peter Huber Kältemaschinenbau AG at Achema 2022At ACHEMA 2022, Huber Kältemaschinenbau will be showcasing high-precision temperature control solutions for the process industry. The product presentation will focus on the Unistat process circulators.
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Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug ManufacturingThe author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.
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Addressing Segregation of a Low-Dosage Direct BlendThe authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
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Stability Indicating Methods for Aluminum Adsorbed Vaccine ProductsThe authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
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Coater Modul for MINILAB XPThe MINILAB XP by DIOSNA is a well-known laboratory processor. With our new Coater Modul we offer a unit with a fluid bed processor and a horizontal coater in one.
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Veltek Associates, Inc.VAI’s manufacturing and testing operations mirror current GMP/GLP standards.
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Don’t underestimate the "small stuff"Learn about the importance of considering human factors testing beyond the initial validation phase. Through two case studies, it illustrates how seemingly minor product changes can trigger regulatory scrutiny. The message is clear: proactive testing and expert guidance are essential to navigate regulatory requirements effectively.
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Using Solar Energy for Process HeatingRenewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
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Vcaps® EntericLatest:
Considerations when Quantifying Amorphous Contents in Milled Powders with CalorimetryInterpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
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Morphologically-Directed Raman Spectroscopy: Uncovering the Good, the Bad, and the Ugly in Drug FormulationsMDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
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Gluing Pills Technology for the Production of Multi-Layer TabletsThis novel technology was developed in response to challenges involved in conventional manufacturing of multilayer tablets, including in-line control of the tablet weight, the tendency to delamination, direct contact between the two tablet layers, and cross contamination.
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Gluing Pills Technology for the Production of Multi-Layer TabletsThis novel technology was developed in response to challenges involved in conventional manufacturing of multilayer tablets, including in-line control of the tablet weight, the tendency to delamination, direct contact between the two tablet layers, and cross contamination.
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Improving the Dissolution of Poorly Soluble APIs with Inorganic Solid DispersionsSolid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.
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Improving the Dissolution of Poorly Soluble APIs with Inorganic Solid DispersionsSolid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.
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Real-Time Measurement of Coating Film ThicknessOptical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
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Exploring a Modern Control Strategy for Wurster CoatingA process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.
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Self-Guided Control of a Fluid Bed Granulation ProcessAdvanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.
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Self-Guided Control of a Fluid Bed Granulation ProcessAdvanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.
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Exploring a Modern Control Strategy for Wurster CoatingA process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.
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New Nexera Prep Better Prep!Shimadzu has introduced its new Nexera Prep Series Preparative Purification Liquid Chromatograph (LC). “Preparative HPLC” is a process in which specific substances are separated and purified from samples.
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Wet Granulation Resolves Tablet Reformulation ChallengesA case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.
