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The Application of Robotics to Aseptic Environmental Surface MonitoringThis article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
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Determination by Analytical Sieving: Particle-Size Distribution, Part IIIThe author discusses the use of analytical sieving to determine the size distribution of granular and course powders and describes proper sieve construction and USP General Test {786}.
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A Look at 30 Years of Change in Pharmaceutical AutomationAutomation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Qualification of a Chromotographic ColumnIn this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.
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Scotland the brave...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.
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Making light work of digital imagingIn the biological arena, new and highly useful fluorescent markers are used to stain or 'label' specific structures of interest. They have transformed the range and applicability for optical observation. These labels are excited and correspondingly emit at specific wavelengths; thus, different facets of a specimen can be 'selected' by controlling the wavelength of the delivered and captured light. For example, labels such as 4',6-diamidino-2-phenylindole (DAPI) are used to highlight the nucleus of a cell and MitoTracker Orange is used for mitochondria. Figure 1 shows an example of a multiple stained section, viewed in fluorescence. There has been an explosion in fluorescent labels for examining biological structures, in fixed and live cell preparations.
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Preparing rapid disintegrating tablets containing taste-masking microgranulesThis article describes how rapidly disintegrating tablets containing a large quantity of an intensely bitter drug were successfully developed with a suitable level of masking, tablet hardness, disintegration property, dissolution profile and mouth feel.
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The Use of Acrylic Resins for Improved Aqueous Enteric CoatingRecent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets
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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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The long awaited revisionThe closing date for comments to be received by the US Pharmacopeia (USP) for proposed revisions to Chapter <231>, which deals with analysis of heavy metals, is 15 December 2008. The USP has been working towards for approximately 4 years and the task has not been easy.
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Packing-Line Improvement Based on a Fault-Tree Analysis ApproachThis article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.
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A partially freeze-dried lyophilization technology for producing fast-melting tabletsA new economical method for producing fast-melting lamina-like dosage forms.
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A Raman spectroscopic method to monitor magnesium stearate in blends and tabletsA new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.
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Dispelling Cleaning Validation Myths: Part IIIn applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.
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Let's Collaborate on IT Best PracticesThe industry should develop a set of best practices for managing information technology systems and not wait for FDA to take the lead.
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Talking Point: Corporate procurementIf delaying the project has little consequence then you should probably not run the project in the first place.
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Applications of Raman spectroscopy in aqueous environmentsRaman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.
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Improving the stability of a suspensionAggregation or coagulation of drug particles in a parenteral suspension can pose a serious threat to product quality, particularly for products that require extended shelf life. In the worst case, aggregation can lead to the formation of a nonresuspendable sediment, known as caking. Controlling physical stability is difficult because of the complexity of this phenomenon. This article gives an overview of the factors that were found to be the most important in our search to improve the physical stability of a pharmaceutical suspension.
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Comparison of Atomization Conditions Between Different Spray Guns Used in Pharmaceutical Film CoatingConsideration of the key process variable will define the ease with which coating processes can be transferred from development to production. This study investigates those factors influencing atomization from two spray guns and examines how development-scale procedures on interchangeable drum coating equipment compare with those typically used in a production environment.
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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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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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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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Plugging the European brain drain to the USSo what is the EU to do? It must grant its younger researchers greater scientific autonomy and academic independence.
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Scaling down biopharmaceutical operations Part 1: FermentationCreation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
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Making tissue culture commercially viableThere are over 250 operations in the EU in various stages of development involving tissue engineering, regeneration and subsequent attempts at commercialization.
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Virtual screening using chemical feature-based pharmacophores and virtual molecule librariesThe discovery of suitable lead structures for new drugs from an inexhaustibly large reservoir of theoretically possible compounds is one of the biggest challenges for the pharmaceutical industry. In the last few years, combinatorial chemistry methods have been developed to synthesize a huge amount of diverse new chemical entities (NCEs), which may subsequently be tested for biological activity in vitro.
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Nature versus nurtureOnce the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.
