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Make Paperless Manufacturing a Reality for your Pharmaceutical FacilityRevolutionize pharmaceutical manufacturing through paperless manufacturing. By eliminating paper-based processes, you can quickly centralize your data, reduce cost and time, minimize errors, and release products faster. Even the simplest “paper on glass” digital systems enable streamlined workflows and can ensure real-time data access and seamless communication. Paperless facilities are a reality! Transform your operations today!
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Control Strategies and Method Development for Nitrosamines in APIs and Drug ProductsWebinar Date/Time: Thu, Nov 7, 2024 9:00 AM PST (12:00 PM EST)
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A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant EnvironmentAn adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.
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Nitrosamine Impurities in Medicinal ProductsIndustry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
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Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulationsTesting the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.
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Extractables and Leachables: An Overview of Emerging ChallengesExtractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.
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Troubleshooting Using Predictive MaintenanceSmart manufacturing transforms management of tablet and capsule equipment and processes.
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Guidelines for Selecting Normal Flow FiltersProper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Terminal Sterilization of Sterile Filtered ProductsTerminal sterilization of aseptically processed drug products is extremely important for patient safety. As such, it is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Overkill type sterilization cycles are not required for a drug manufacturer to make a terminal sterilization claim. Many different time and temperature combinations that are much more product friendly can be used to safely terminally sterilize drug products.
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In a Digital Gold Rush, Data Integrity is PricelessData integrity is crucial in unlocking novel data-based insights.
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Selecting a CMO Partner for Sterile Injectable Manufacturing (Nov 2023)Vetting a CMO for sterile injectable fill finish means more than capacity and equipment. This white paper from Jubilant HollisterStier discusses the range of factors to consider when outsourcing manufacturing for aseptically filled and terminally sterilized products.
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Reducing Risk With Innovative Surface Cleaning SystemsSean Imlay, FG Clean Wipes, highlights the Saturix® Surface Cleaning System during INTERPHEX 2022. Watch this video to learn more about:
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Solving the Insoluble: Webinar on the Science and Application of the Dispersome® TechnologyWebinar Date/Time: Tue, Nov 12, 2024 9:00 AM EST
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Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?Advanced manufacturing technologies are available, but challenges need to be addressed.
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Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime ProxetilThis study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
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Understanding the Benefits of Harnessing Just in Time Manufacturing as a Supply Chain Solution for Managed Access ProgramsChallenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.
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The Field Guide to Pharmaceutical Powder Characterization (July 2023)If you want to learn more about the physical characterization of your pharmaceutical powders, download this free e-book. You will find real measurement data that has been collected from a range of characterization methods, including particle, surface area and pore size analysis, powder rheology, and X-ray diffraction. Deepening your understanding of bulk particle properties is just the first step to get more predictable formulations and optimized processes.
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3D Screen Printing: Enabling A New Generation of Complex Formulations3D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.
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Navigating an Uncertain Regulatory Environment for mRNA-based ProductsRegulations for mRNA products are evolving as the market for mRNA expands.
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Raman Detects Pharma Processing FingerprintsRaman spectroscopy delivers real time, non-destructive process insights for critical process parameters to monitor pharmaceutical manufacturing.
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Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Effective and Efficient Weighing of Potent CompoundsThe advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
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Manufacturing Considerations for Sourcing GMP Fermentation ServicesThe authors describe the critical aspects of an ideal fermentation services provider.
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The Lighthouse Effect: Using Technology to Improve Life Sciences ManufacturingLighthouse manufacturing techniques utilize technology and automation to streamline production.
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Changing the Dynamic of CROsThrough its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.
