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Continued process verification for a cleaning validation program begins once the validation study is complete.

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The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.

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Pure 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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The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.

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How to avoid invisible and airborne contamination.

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There is a rapidly growing ageing population that requires sophisticated medical devices and newer drugs. This is likely to result in an increase in the use of robotics to improve manufacturing efficiency. This article looks at the role of SCARA robots in pharmaceutical plants and laboratories.

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Recent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.

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More than 6 years have elapsed since the US Food and Drug Administration's (FDA's) 21 CFR Part 11 regulations regarding the use of electronic records and electronic signatures came into effect.1 In February 2003, FDA issued new draft guidance concerning the scope and application of Part 11, which describes how the agency intends to interpret and enforce the requirements during its ongoing re-examination of the regulations.2 Many people in the pharmaceutical industry have welcomed this new guidance and see it as a positive development that will lead to a simplified FDA approach to Part 11 and a significant reduction in the industry's compliance burden.

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A training program at Rutgers University combines the disciplines of engineering and pharmaceutics to provide a thorough educational experience in drug manufacturing.

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While single-use technologies can be used for filtration, storage and at connection points in egg-based vaccine production, their use multiplies in cell-based applications.

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The 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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Bioadhesive 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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Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

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The 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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Nanotechnology is believed to hold enormous promise for the future of medicine and healthcare...

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The construction of a new oral solid form (OSF) plant is an important decision and a real challenge. The team in charge of the basic conceptual design has to ensure that the new plant will be up-to-date and efficient not only at start-up, but for the next 15–20 years. This means that the project must be able to adjust to capacity changes, product changes and technology changes. It sometimes seems like an impossible challenge.

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The creation in the Paris Region of a multidisciplinary Institute of Technology will bring together the best researchers in world, innovative SMEs and the research centres of large industrial groups.

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When planning the installation of a new stainless steel process pipeline, it is important to understand the significance of using the best possible materials and techniques to ensure it is clean when installed. This article examines the factors that must be considered when planning and constructing a new process line.

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The collection, investigation and monitoring of suspected adverse drug reactions (SADRs), and associated product use and complaint information, is a regulatory requirement for all manufacturers of pharmaceuticals for human use.1 This process, called pharmacovigilance or drug safety, appears to be fairly standardized between different pharmaceutical companies and usually contains the elements outlined in Figure 1.

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IAdvances in pressurized metered-dose inhalers (pMDIs) in terms of formulation capability and the performance of the container closure system enable products to be developed faster and with less technical risk. Despite new delivery devices for new molecules breaking into the pMDI market, pMDIs have the ability to gain regulatory approval significantly faster than a novel device, which could save a company many hundreds of millions of pounds.

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Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.

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The worldwide market for biopharmaceuticals was estimated to be $50 billion in 2005. North America accounts for 60% in terms of revenue and R&D. Europe accounts for 20% and Japan 10%. It is also estimated that 400–500 biotech drugs are under clinical development for various disease conditions. Biopharmaceuticals are being developed to fight cancer, viral infections, diabetes, hepatitis and multiple sclerosis. The distinct families of biopharmaceuticals include

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Closed and disposable sterility testing devices reduce the risk of false positive results during sterility testing. To further prevent such results, some pharmaceutical manufacturers use the device inside a sterility testing isolator, which is decontaminated using sterilant gases or vapours. In this study, closed, disposable sterility test devices were exposed to two 90 minute vaporous phase hydrogen peroxide (VPHP) decontamination cycles within a sterility testing isolator and tested for device integrity, bacteriostasis/fungistasis and non-volatile residue content. The results showed that the VPHP used to decontaminate the isolator before sterility testing did not affect the device.

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Fundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.

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In this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2

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A newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and technologies under one platform.

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Sterile 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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Process analytical technology paved the way for continuous manufacturing.

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Why do the biotech ventures mange to have such promising drug candidates while pharmaceutical R&D is facing a drug deficit?