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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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Application of the Weisberg t-test for OutliersDetermining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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Pharmaceutical Dust Extraction and Vacuum CleaningDust extraction and centralized vacuum cleaning systems vary in their design, performance and costs. Different companies have different approaches to their design, however, there are some basic rules that must be followed if these systems are going to be immediately effective and avoid future problems.
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Is your IT infrastructure qualified?A new Good Automated Manufacturing Practice (GAMP) guide on IT Infrastructure Control & Compliance was launched in Chicago (IL, USA) 23 August 2005.1 The guide is intended to support pharmaceutical companies in their effort to establish a well-defined and compliant infrastructure. This article discusses different aspects of the guide that may support your organization in getting — and keeping — your infrastructure under control.
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Sugar spheres: a versatile excipient for oral pellet medications with modified release kineticsPellets are a multiparticle, solid form of medication. The individual pellets are almost spherical with diameters usually between 100 and 2000 ?m.
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Talking Point: The patent problem with metabolitesFDA data indicate expenditure by pharmaceutical companies on R&D has doubled since 1996. Why is intensive research yielding so few patented inventions and so few new drugs?
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A Mass Transfer of KnowledgeA comprehensive book about mass transfer benefits from the author's personal touch.
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Ultrasonic calorimetry of membranesCan high-resolution sound velocity measurements be used as an analytical tool?
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Glass Reactor Vessel — Value Sealing InnovationActive pharmaceutical ingredients (APIs) have become more potent, therefore the requirements of good manufacturing practice (GMP) are making ever more stringent demands on valve design and sealing. An absence of dead space, ease of cleaning and flushing is the norm for valves where cross contamination must be avoided at all costs. Sealing valves to glass reaction vessels has lagged behind valve sealing for steel vessels.
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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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Successfully Outsourcing Formulation DevelopmentConsiderations for Emerging Biopharmaceutical CompaniesSuccessfully taking a new chemical entity from proof-of-concept to commercialization requires the biopharmaceutical company to carefully evaluate a contract services provider's formulation department and ability to become a fully integrated supplier.
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Sieve Use in the Pharmaceutical IndustryAsieve or screener is an essential part of every pharmaceutical production process, particularly as product quality and integrity are so important. The use of a sieve gets rid of oversized contamination to ensure that ingredients and finished products are quality assured during production and before use or despatch.
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Documentary EvidenceA look at the role of document management in the product life-cycle and how this can lead to the effective use of CTDs and e-CTDs when compiling compulsory regulatory submissions...
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The Next Generation of Aseptic Processing EquipmentThe industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.
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Steps Towards Demystifying Risk-Based Decision MakingIt is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
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Creating a compelling business case for your LIMS implementationThis article examines the development of a business case to secure coveted funding for a LIMS implementation. Information on hard cost savings and soft benefits of implementing a LIMS system, and managing the compilation of the cost justification are covered.
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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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Why It Pays To Be CleanProcess industries are faced with increasing demands for product safety, improved quality, efficiency and profitability. The chemical, pharma and cosmetic industries are no exception.
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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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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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Computer system validation ? increasing supplier valueAll sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.
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Reducing Time to Market with A Science-Based Product Management StrategyTo progress compounds from candidacy to IND rapidly, manufacturers can adopt a strategy that involves front-loading as many studies as possible to reduce the number of potential problems, finding the best solid form for manufacture through a polymorph study or screen, developing a manufacturing process and formulation that preserves this form, and adopting process analytical technology and quality-by-design principles.
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Discrete Element Simulation for Fundamental Process UnderstandingThe pharmaceutical industry handles large volumes of granular materials such as powder blends for tablet production and filled capsules everyday (1, 2). Slight changes in ingredient properties or process operation conditions can have a major effect on a finished product's quality. Given the market and regulatory uncertainties that are commonly associated with drug product development, pharmaceutical companies typically have several drugs in various developmental stages at the same time. Because of this volume, the industry must have computer-based rapid-prototyping tools that can efficiently capture and resolve the technical aspects of drug product development so that companies can confidently make decisions about drug portfolio management and planning (3, 4).
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Pharmaceutical clean rooms: specialty hygiene coatingsClean rooms are areas in which it is essential that microorganisms are not allowed to proliferate because they could contaminate pharmaceuticals and directly affect human health.
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Lean Manufacturing practice in a cGMP environmentDeveloped in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.
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The Clarification of Bioreactor Cell Cultures for BiopharmaceuticalsClarification processes are critical steps in production of biological products because they directly affect yield, product consistency, and reproducibility.
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Discrete Element Simulation for Fundamental Process UnderstandingThe pharmaceutical industry handles large volumes of granular materials such as powder blends for tablet production and filled capsules everyday (1, 2). Slight changes in ingredient properties or process operation conditions can have a major effect on a finished product's quality. Given the market and regulatory uncertainties that are commonly associated with drug product development, pharmaceutical companies typically have several drugs in various developmental stages at the same time. Because of this volume, the industry must have computer-based rapid-prototyping tools that can efficiently capture and resolve the technical aspects of drug product development so that companies can confidently make decisions about drug portfolio management and planning (3, 4).
Latest:
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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Rapid Results for life Science ApplicationsEssentially, RAD is a set of tools…that allows for rapid prototyping and reiterative testing that enable faster development and implementation of new applications.
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High-Resolution Ultrasonic Spectroscopy: Analysis of MicroemulsionsThis article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.
