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Optimizing the Mixing ProcessImproved products and processes that are cleaner, less expensive, more manageable and take up less space are benefits that you would expect to be snapped up by any industry. But not so in pharmaceutical manufacturing, where traditional methods prevail.
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Viral filtration of plasma-derived human IgGHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.
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Outsourcing Beyond the Comfort ZonePharmaceutical companies can evaluate the opportunities of global outsourcing by considering the strategic approaches of other industries and of the pharmaceutical companies already outsourcing outside the United States and Europe.
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Optimising High-Potency ManufactureEffective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.
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Effect of raw materials on the formulation of norfloxacin tabletsAlthough physicochemical preformulation screening is practised universally within the pharmaceutical industry, physicomechanical screening is applied to a lesser extent and often only where a problem exists.
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Hyperthermophilic Microorganisms and USP Hot Water SystemsThe author discusses why two of the industry's common practices for preventing microorganism contamination in USP hot-ware and purified-water systems may have no scientific basis.
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Transforming Development Productivity Using Integrated AutomationThe FDA initiative —Process Analytical Technologies (PAT) — is slowly gaining momentum, creating a revolution in manufacturing and testing processes that aims to ensure product quality. Its growth will encourage faster testing techniques to bring analytical testing closer to on- and at-line testing during the product manufacturing process.
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Using remote monitoring to boost performanceThe evolution of sophisticated monitoring systems has been accelerated because of stringent EU legislation surrounding the pharmaceutical industry and the escalating demand for preventative maintenance techniques. This article gives an overview of the benefits of implementing these systems in pharmaceutical manufacturing.
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The shape of things to comeParticle shape is an important parameter to monitor in the pharmaceutical sector, but has, historically, been too complicated to measure and be utilized on a routine basis. A newly developed digital technique could change this.
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Characterization with Atomic Force Microscopy, Topographic, and 3D RamanThe authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.
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Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug DevelopmentThe author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.
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Advances in Pharmaceutical Process AnalysersProcess analysers have evolved from basic analogue devices with adjustable potentiometers, analogue current outputs and alarm relays into smart, powerful, two-way digital transmitters with advanced features, such as automatic calibration and self-diagnostics, that can transmit more information, more accurately. This article will discuss advances in process analytical devices and how they can be applied to both new and existing pharmaceutical facilities.
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Solubility, Polymorphism, Crystallinity, and Crystal Habit of Acetaminophen and Ibuprofen by Initial Solvent ScreeningSolubility, polymorphism, crystallinity, and crystal habit of acetaminophen and racemic (+/-)-ibuprofen were determined by initial screening of 23 solvents for scale-up. Solubility curves were constructed, and solubility at 25 degrees Celsius was plotted against the dielectric constants of various solvent as a fingerprint for solute identification. The total "form space" for acetaminophen and racemic (+/-)-ibuprofen were calculated to be 222 and 257, respectively. Various crystal habits and sizes for ibuprofen and acetaminophen were observed.
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USP Initiatives for the Safe Use of Medical GasesUSP monographs, if they are consistently observed and applied, can help reduce medical gas errors.
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The packaging connectionCreating better pharmaceutical and medical products with packaging partnerships.
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Outsourcing Beyond the Comfort ZonePharmaceutical companies can evaluate the opportunities of global outsourcing by considering the strategic approaches of other industries and of the pharmaceutical companies already outsourcing outside the United States and Europe.
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Not to be sniffed atThe attraction of nasal administered therapeutic agents is obvious, including faster onset of action, increased compliance and avoiding degradation during first pass metabolism.
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Trends and Innovations in Continuous CoatingThe technique of continuous coating has undergone great change since it was introduced to the pharmaceutical industry more than a decade ago, and its benefits have multiplied.
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Cocktail-Solvent Screening to Enhance Solubility, Increase Crystal Yield, and Induce PolymorphsThe authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.
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Removal of Particles by Ultrafiltration SystemsPure water is a raw material of particular importance to the pharmaceutical industry. Drinking water is the basis for the treatment of water for pharmaceutical applications; it is the starting point for the production of the various pharmaceutical water qualities, such as purified water, highly purified water and water for injection.
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Predicted Contamination Levels in Cleanrooms When Cleanroom-Dressed People Are the Contamination SourceCalculations show the predicted contamination levels in cleanrooms with turbulent mixing air and with vertical unidirectional airflow when people are dressed in modern cleanroom clothing systems. Comparisons are made between operation theatres and cleanrooms.
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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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Viral filtration of plasma-derived human IgGHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.
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In-Process Control Methods for the Manufacture of APIsIn-process methods are key components of quality control in a chemical manufacturing plant. These methods ensure that a production reaction step conducted by trained operators within the entire validated process will produce a quality chemical entity in the expected yields. The presence of impurities and related compounds (derived from the reaction or secondary reactions) is a critical parameter that determines a synthetic material's quality.
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Aseptic Production, Gowning Systems, and Airborne ContaminantsStudy results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.
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Low-Temperature Thermal Analysis are Key to Formulation DesignElectrical resistance, low temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of a lyophilization cycle.
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Predicting Long-Term Storage Stability of Therapeutic ProteinsPredicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.
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Raman as a PAT ToolThe first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.
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Freeze-Drying with Closed VialsThe authors present an aseptic-filling process for freeze-dried liquids using the closed-vial technology.
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Analysing Raw Materials and Formulations Using High Resolution Ultrasonic SpectroscopyHR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.
