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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.
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Solubility, Polymorphism, Crystallinity, Crystal Habit, and Drying Scheme of (R, S)-(±)-Sodium Ibuprofen DihydrateThe racemic compound (R, S)-(±)-ibuprofen is a popular and well understood active pharmaceutical ingredient, but it has several disadvantageous formulation properties such as poor solubility, low melting point, and potential esterification with excipients containing an hydroxyl group. The authors investigate the use of an (R, S)-(±)-ibuprofen salt to evaluate these problems using various analytical methods to determine the polymorphism, crystallinity, and drying scheme.
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Speeding up the move to PATThe big challenge for pharmaceutical companies is to mathematically model their production processes, combining both data from the laboratory and the production process.
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Vibration Technology for Active Dry-Powder InhalersA new active dry powder inhaler has been developed using vibration frequencies to aerosolize powders.
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Hot-melt extrusion: an emerging drug delivery technologyHot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.
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A new system for the rapid transfer of sterile liquid through a containment wallSterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.
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Sustainability at Work: Solar EnergyNew Age Industries, a manufacturer of plastic molding and fittings for the pharmaceutical and biopharmaceutical industries, implements a solar-energy project at its Pennsylvania facility.
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The Benefits of Process Information Management in R&D - A Case StudyThis case study examines the benefits of introducing process information management software to a pharmaceutical pilot plant. The advantages illustrate the potential for process development and commercial manufacturing improvements that are available to the pharmaceutical industry.
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How Banning Titanium Dioxide Might Impact PharmaThe impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
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Understanding Internal Release LimitsInternal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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Planning and Designing a Pharmaceutical Facility: A Process Designer's ViewPlanning manufacturing capacity in the pharmaceutical industry is not for the faint-hearted. How can process designers help their clients to overcome some of the problems they face when planning to introduce new capacity? This article sets out to explain some of the techniques that are being employed in the early stages of project development.
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Uniformity of Bioprocessing Equipment ManufacturingThe American society of Mechanical Engineers's Council on Codes and Standards has formed 10 subcommittees to update and broaden the scope of the BPE standards.
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Excipient-Excipient Interactions in Pharmaceutical Systems Intended for Topical ApplicationBioadhesive films cast from aqueous blends of PMVE/MA have diverse uses, such as a means of establishing an electrically conducting interface for bioelectrodes and as an adhesive drug delivery matrix.
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The state of validation in the European UnionSince the formation of the European Union (EU) in 1993, each member state has brought along its own regulatory baggage, namely the standards and regulations that their companies are formally required to comply with. These standards and regulations still apply for any pharmaceutical products a native manufacturer decides to market within their homeland. When the same manufacturer markets its pharmaceutical products to consumers in other EU member states, the regulatory directives of the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA) apply as well.
