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Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments
by Sam A. HoutDescribes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.
Sterile Product Development
by Parag Kolhe Mrinal Shah Nitin RathoreThis comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: * Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines * Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures * Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
STESSA 2000: Proceedings of the Third International Conference STESSA 2000, Montreal, Canada, 21-24 August 2000
by Federico M. Mazzolani; Robert TremblayThis is a review of developments in the behaviour and design of steel structures in seismic areas. The proceedings look at the analytical and experimental research on the seismic response of steel structures, and cover topics such as global behaviour and codification, design and application.
STESSA 2003 - Behaviour of Steel Structures in Seismic Areas: Proceedings of the 4th International Specialty Conference, Naples, Italy, 9-12 June 2003
by Federico M. MazzolaniPresenting a comprehensive overview of recent developments in the field of seismic resistant steel structures, this volume reports upon the latest progress in theoretical and experimental research into the area, and groups findings in the following key sections:· performance-based design of structures· structural integrity under exceptional loading· material and member behaviour· connections· global behaviour· moment resisting frames· passive and active control· strengthening and repairing· codification· design and application
Steuerbares Reibverhalten trockenlaufender Tribosysteme (Mechanics and Adaptronics)
by Zhenwei MiaoDie vorliegende Arbeit untersucht einen neuen Freiheitsgrad zur Beeinflussung der Reibung, indem ein adaptiver Reibbelag entwickelt wird, dessen Reibung aktiv durch den Einsatz von den Piezoaktoren beeinflusst wird, und zwar primär durch Änderung bzw. Kombination verschiedener Materialpaarungen im Betrieb. Ein tribologisch gezielt beeinflussbares Reibsystem ermöglicht für einen breiteren Anwendungsbereich einen Betrieb mit geringer Reibleistung und geringem Verschleiß, indem die tribologischen Eigenschaften bzw. die Reibung bei Veränderungen der Betriebsbedingungen (z.B. Gleitgeschwindigkeit, Temperatur) durch eine Regelung angepasst werden. Bei trockenlaufenden Tribosystemen tritt für einige Reibmaterialien bei konstanter Normalkraft mit zunehmender Gleitgeschwindigkeit ein Abfall des Reibwertes auf. Dieser Abfall ist häufig unerwünscht, weil er beispielweise zu Reibschwingungen des Gesamtsystems oder zur Verringerung der Effektivität in Bremsen oder Kupplungen führen kann. Ein wesentliches Motiv dieses Vorhabens ist das Bestreben, den Reibwert des trockenlaufenden Reibbelages mit zunehmender Gleitgeschwindigkeit konstant zu halten oder ansteigen zu lassen, indem verschiedene unterschiedliche Reibmaterialien einzeln oder zusammen in Kontakt mit dem Gegenkörper gebracht werden. Reibbeläge mit adaptiven Komponenten, deren Eigenschaften gezielt verändert werden können, eröffnen ein breites Anwendungsspektrum in diversen Bereichen des Maschinenbaus.
Steuerungstechnik für Ingenieure: Ein Überblick (essentials)
by Bernd SchröderFür selbstarbeitende und automatisierte (Produktions-) Prozesse werden Steuerungstechniken genutzt. Die hierzu eingesetzten Elemente arbeiten mechanisch, pneumatisch, hydraulisch, elektrisch oder elektronisch. Ausführende Organe sind unter anderem Ventile, Pumpen, Motore, Schalter, Sensoren und Relais. Die hierfür gängigen Symbole werden vorgestellt und können in Schemata eingesetzt werden. Gelegentlich ist die Erstellung sequenzieller Schaltungen hilfreich. Für eine hohe Flexibilität bietet sich die speicherprogrammierbare Steuerung (SPS) an.
Steve Jobs
by Walter IsaacsonLa biografía definitiva de Steve Jobs, el fundador de Apple, escrita con su colaboración. La muerte de Steve Jobs ha conmocionado al mundo. Tras entrevistarlo en más de cuarenta ocasiones en los últimos dos años, además de a un centenar de personas de su entorno, familiares, amigos, adversarios y colegas, Walter Isaacson nos presenta la única biografía escrita con la colaboración de Jobs, el retrato definitivo de uno de los iconos indiscutibles de nuestro tiempo, la crónica de la agitada vida y abrasiva personalidad del genio cuya creatividad, energía y afán de perfeccionismo revolucionaron seis industrias: la informática, el cine de animación, la música, la telefonía, las tabletas y la edición digital. Consciente de que la mejor manera de crear valor en el siglo XXI es conectar la creatividad con la tecnología, Jobs fundó una empresa en la que impresionantes saltos de la imaginación van de la mano de asombrosos logros tecnológicos. Aunque Jobs colaboró en el libro, no pidió ningún control sobre el contenido, ni siquiera ejerció el derecho a leerlo antes de su publicación. No rehuyó ningún tema y animó a la gente que conocía a hablar con franqueza. «He hecho muchas cosas de las que no me siento orgulloso, como dejar a mi novia embarazada a los veintitrés años y cómo me comporté entonces, pero no hay ningún cadáver en mi armario que no pueda salir a la luz». Jobs habla con una sinceridad a veces brutal sobre la gente con la que ha trabajado y contra la que ha competido. De igual modo, sus amigos, rivales y colegas ofrecen una visión sin edulcorar de las pasiones, los demonios, el perfeccionismo, los deseos, el talento, los trucos y la obsesión por controlarlo todo que modelaron su visión empresarial y los innovadores productos que logró crear. Su historia, por tanto, está llena de enseñanzas sobre innovación, carácter, liderazgo y valores. La vida de un genio capaz de enfurecer y seducir a partes iguales. Reseña:«El fallecimiento de Steve Jobs ha precipitado un alud de libros sobre su figura. De todos ellos, la aproximación más completa e interesante al personaje es la de Isaacson.»La Vanguardia
Steve Jobs: Edicion en Español
by Walter IsaacsonLa muerte de Steve Jobs ha conmocionado al mundo. Tras entrevistarlo en más de cuarenta ocasiones en los últimos dos años, además de a un centenar de personas de su entorno, familiares, amigos, adversarios y colegas, Walter Isaacson nos presenta la única biografía escrita con la colaboración de Jobs, el retrato definitivo de uno de los iconos indiscutibles de nuestro tiempo, cuya creatividad, energía y afán de perfeccionismo revolucionaron seis industrias: la informática, el cine de animación, la música, la telefonía, las tabletas y la edición digital. Consciente de que la mejor manera de crear valor en el siglo xxi es conectar la creatividad con la tecnología, fundó una empresa en la que impresionantes saltos de la imaginación van de la mano de asombrosos logros tecnológicos. Aunque Jobs colaboró con el libro, no pidió ningún control sobre el contenido, ni siquiera el derecho a leerlo antes de la publicación. No rehuyó ningún tema y animó a la gente que conocía a hablar con franqueza. Jobs habla con sinceridad a veces brutal sobre la gente con la que ha trabajado y contra la que ha competido. De igual modo, sus amigos, rivales y colegas ofrecen una visión sin edulcorar de las pasiones, los demonios, el perfeccionismo, los deseos, el talento, los trucos y la obsesión por controlarlo todo que modelaron su visión empresarial y los innovadores productos que logró crear. Su historia, por tanto, es el retrato de una fascinante vida: la de un genio capaz de enfurecer y seducir a partes iguales.
Steve Jobs
by Patricia LakinWritten especially for a young audience, a must-read biography of Steve Jobs: visionary, entrepreneur, inventor, and cofounder of Apple.Visionary. Pioneer. Little terror. Entrepreneur. Inventor. College dropout. Creative genius. These are just a few of the words used to describe the late Steve Jobs, cofounder, chairman, and chief executive officer of Apple Inc. Available in both paperback and hardcover, Patricia Lakin's biography for middle-grade readers tells the captivating and inspirational story of the 'Thomas Edison' of our time.
Steve Jobs: Thinking Differently
by Patricia LakinWritten especially for a young audience, a must-read biography of Steve Jobs: visionary, entrepreneur, inventor, and cofounder of Apple. Visionary. Pioneer. Little terror. Entrepreneur. Inventor. College dropout. Creative genius. These are just a few of the words used to describe the late Steve Jobs, cofounder, chairman, and chief executive officer of Apple Inc.
Steve Jobs: A Biographic Portrait
by Kevin LynchThis is a stunning visual guide to the life and works of entrepreneur Steve Jobs. Easily one of the most influential innovators of the twenty-first century, Steve Jobs has fundamentally shaped the way in which we communicate and, even more broadly, live our lives. In this information-packed graphic biography, Steve Jobs&’ remarkable talent and genius are explored through bold design and original graphics. Kevin Lynch explores Jobs' journey from savvy salesman, to his rivalry and market competition with Bill Gates, and his shift towards radical innovations in later life. This technological innovator led a fascinating, astounding and ultimately too short life, that irreversibly impacted how we communicate. Steve Jobs is a visual celebration and comprehensive study of &‘The Maverick&’ and his work; and a must-have for any fan of Apple products.
Steve Jobs: Leader Strategist
by Cynthia A. Montgomery David B. Yoffie"In 2009, Fortune magazine published one of its many cover stories on Steve Jobs, this time naming him the CEO of the decade. Explaining why they chose to bestow this honor on Jobs, Stephanie Mehta argued that “No business figure has crushed it the way Jobs has these past 10 years. Even as the rest of business boomed and then crashed, he resuscitated Apple, which, many forget, was in horrific shape at the dawn of the decade, and simultaneously radically reinvented the music, movie, and telecommunications industries.”
Steve Jobs (edició en català)
by Walter IsaacsonLa biografia definitiva de Steve Jobs, creador d'Apple, escrita amb la seva total col·laboració. La mort de Steve Jobs ha commogut el món. Després de tenir-hi més de quaranta entrevistes en els darrers dos anys, i amb més d'un centenar de persones del seu entorn: familiars, amics, adversaris i col·legues, Walter Isaacson ens presenta l'única biografia escrita amb la col·laboració de Jobs, el retrat definitiu d'una de les icones indiscutibles del nostre temps, la crònica de l'agitada vida i la desgastant personalitat d'un geni que, amb la seva creativitat, energia i afany de perfeccionisme, va revolucionar sis indústries: la informàtica, el cine d'animació, la música, la telefonia, les tauletes i l'edició digital. Conscient que la millor manera de crear valor al segle XXI és connectar la creativitat amb la tecnologia, Jobs va fundar una empresa en la qual els impressionants salts de la imaginació van de bracet de sorprenents fitestecnològiques. Tot i que Jobs va col·laborar en el llibre, no va voler controlar el contingut, ni tan sols exercir el dret a llegir-lo abans de la publicació. No va defugir cap tema, i va encoratjar la gent que coneixia a parlar amb franquesa. «He fet moltes coses de les quals no em sento orgullós, com deixar la meva novia embarassada als vint-i-tres anys i la manera com em vaig comportar aleshores, però no hi ha cap cadàver al meu armari que no pugui sortir a la llum.» Jobs parla amb sinceritat, de vegades brutal, sobre la gent amb la qual ha treballat i contra la que ha competit. De la mateixa manera, els seus amics, rivals i col·legues ofereixen una visió gens ensucrada de les passions, els dimonis, el perfeccionisme, els desitjos, el talent, els trucs i l'obsessió per controlar-ho tot que varen modelar la seva visió empresarial i els innovadors productes que va aconseguir crear. La seva història, per tant, està plena d'ensenyaments sobre innovació, coratge, lideratge i valors. La vida d'un geni capaç d'enfurismar i de seduir a parts iguals.
Stevia: The Genus Stevia
by A. Douglas KinghornStevia rebaudiana is a remarkable South American plant that has become widely used in certain parts of the world as a natural sweetening agent and dietary supplement. Purified extracts of S. rebaudiana have been used as sweeteners and flavor enhancers in the food industry in Japan for over a quarter of a century, and have been found to be up to 300
Stevioside: Technology, Applications and Health
by Sirshendu De Sourav Mondal Suvrajit BanerjeeStevioside is one of the naturally occurring sweeteners, belonging to the diterpene glycoside family, which can be widely applied in food, drinks, medicine and consumer chemicals. It is a good dietary supplement, being non-calorific, thermally stable, non-toxic, with a sugar-like taste profile, and suitable for diabetics, phenylketonuria patients and the obese. It is also non-fermentable, and exhibits anti-carcinogenic, antioxidant and anti-hyperglycemic properties. Stevioside tastes about 300 times sweeter than 0.4% sucrose solution. Thus, it offers a reasonably rare combination of health benefits and taste benefits, making the extraction of stevioside is an area of active research for the food industry as well as academic food scientists.With the rapid increase in the popularity of stevioside as a sugar substitute, particularly with regard to its associated health benefits, there is a need for more efficient and feasible extraction processes for stevioside in the near future. This book offers an in-depth look at perhaps the major “sugar alternative of the future”, up-to-date and in line with the latest global legislation regarding its suitability for consumption and its scope for application.
Stewarding Sustainability Transformations: An Emerging Theory and Practice of SDG Implementation
by Petra KuenkelIn the context of the world’s pressing sustainability challenges this new Report to the Club of Rome presents a novel approach to navigating collaborative change in partnerships between governments, research institutions, corporations and civil society activists. With reference to the 17 Sustainable Development Goals and the Planetary Boundaries it introduces the theory and practice of Collective Stewardship as a management tool that respects the integrity of human and natural systems. Drawing on the work of transdisciplinary scientific scholars and seasoned sustainability practitioners, it shows how transformative change can be built on life’s inherent tendency to generate patterns of vitality and resilience. This ground-breaking monograph shows workable pathways to stewarding patterns of aliveness in social and ecological systems at all levels of the global society. As a highly regarded author and expert in collective leadership, Petra Kuenkel inspires academics and practitioners alike to explore new routes towards co-creating responsible futures in the era of the Anthropocene, where the human footprint has begun to change the course of planetary evolution. She invites decision-makers, researchers, planners and social activists to become stewards of systems patterns, enhance their collaborative competencies and guide life-enhancing socio-ecological interaction at scale. The conceptual architecture the author elaborates builds transformation literacy and boils down to a practical guidance for planning and implementing interventions across all sectors of society. It helps bring about change through a deliberate combination of enlivening narratives, empowering metrics, enabling processes, multi-level governance, guiding regulations, and life-supporting innovation. This comprehensive book sets a new direction in the field of sustainability transformations and will become a foundation for planning collective action and achieving impact at scale.
Stewards of the Grasslands: Canadian Ranchers in Their Own Words
by Dana ReiterThis book offers a series of interviews with Canadian ranchers that highlight the innovative and effective ways that they manage vast swaths of grassland for two complementary goals: commercial viability and sustainable habitats. The book’s author is an academic who grew up among ranchers in the grasslands of Canada, and the expertise and viewpoints she has distilled from these interviews complement the academic literature in accessible and surprising ways . As these productive landscapes face increasingly perilous threats such as development, economic pressures, and extreme weather events, it is the ranchers who live on and manage these native grasslands who are passionate about conserving them.This book is about them, their experiences and the realities of their lives, their view of the world, sharing their knowledge to assist younger ranchers, and their contributions to Canada’s species at risk conservation goals, food security and economy. The book offers practical advice for ranchers, but also reveals the depth of attachment and dedication these ranchers have for the grasslands. They are conservationists at heart, as they not only understand that their livelihood is dependent on the health of the ecosystem they manage, but they also have a deep connection to the land, nurtured oftentimes for many generations. Academics and ranchers have much to learn here, but the book – most of which is the words of the ranchers themselves - is written to give the general public an understanding of this vocation and its role in the conservation of our last remaining grasslands.
Stewardship of Future Drylands and Climate Change in the Global South: Challenges and Opportunities for the Agenda 2030 (Springer Climate)
by Simone Lucatello Elisabeth Huber-Sannwald Ileana Espejel Natalia Martínez-TagüeñaThis volume integrates a conceptual framework with participatory methodologies to understand the complexities of dryland socio-ecological systems, and to address challenges and opportunities for stewardship of future drylands and climate change in the global south. Through several case studies, the book offers a transdisciplinary and participatory approach to understand the complexity of socio-ecological systems, to co-produce accurate resource management plans for sustained stewardship, and to drive social learning and polycentric governance. This systemic framework permits the study of human-nature interrelationships through time and in particular contexts, with a focus on achieving progress in accordance with the 2030 United Nations Agenda for Sustainable Development. The book is divided into four main sections: 1) drylands and socio-ecological systems, 2) transdisciplinarity in drylands, 3) interculturality in drylands, and 4) the governance of drylands. Expert contributors address topics such as pastoralism and the characteristics of successful agricultural lands, the sustainable development goals and drylands, dryland modernization, and arid land governance with a focus on Mexico. The volume will be of interest to dryland researchers, sustainable development practitioners and policymakers.
Stewardship of the Built Environment
by Robert A YoungWhen we think of green building, we tend to picture new construction. But Robert A. Young argues that the greenest building is often the one that has already been built. In Stewardship of the Built Environment, he shows how retrofitting existing structures holds untapped potential for achieving sustainable communities. Stewardship of the Built Environment explores the social, environmental, and economic benefits of reuse-from the societal value of reusing existing buildings to financial incentives available for refurbishment. Readers will become familiar with essential terminology; sustainability and historic preservation metrics; government oversight processes; and opportunities for smart growth afforded by rehabilitation. This knowledge is key to preserving the past while building a sustainable future.
Stick and Rudder: An Explanation of the Art of Flying
by Wolfgang LangewiescheIn the early 1940's, Wolfgang Langewiesche wrote a series of articles in Air Facts analyzing the various aspects of piloting techniques. Based on these articles, Langewiesche's classic work on the art of flying was published in 1944. This book explains precisely what pilots do when they fly, just how they do it, and why. These basics are largely unchanging. The book applies to large airplanes and small, old airplanes and new, and is of interest not only to the learner but also to the accomplished pilot and instructor. Today, several excellent manuals offer the pilot accurate and valuable technical information. But Stick and Rudder remains the leading think-book on the art of flying.
Stiffness and Damping in Mechanical Design
by Eugene RivinOffers designers and users of mechanical systems an overview of structural stiffness and damping and their critical roles in mechanical design. The text assesses the relationship between stiffness and damping parameters in mechanical systems and structural materials. An accompanying disk contains detailed analyses of stiffness- and damping-critical systems.
Still Broken
by Stephen M. DavidsonThe debate over health care policy in the U. S. did not end when President Obama signed the landmark Patient Protection and Affordable Care Act (PPACA) on March 23, 2010. Since then, half the states have sued and federal judges have issued conflicting rulings about the law's constitutionality. In addition, the new Republican-controlled House of Representatives voted to repeal it, and Republicans have pledged to bring it up again during negotiations over the 2012 federal budget. The continuing controversies over PPACA are only one reason that Still Broken: Understanding the U. S. Health Care System is a must-read for engaged citizens, policymakers, students, and scholars alike. The book takes a close look at our problems, proposes solutions to them, and explains how to navigate our political system to effect positive change. It will help readers: * Assess the arguments made by partisans on both sides of the continuing debate. * Understand why President Obama was able to get Congress to pass a comprehensive reform bill even though most of his predecessors tried and failed. * Understand why so many Americans are either confused about its value or actually oppose it. In the book's first part, Stephen M. Davidson paints a lucid picture of the way that the health system works and the forces that produced the monumental problems that we face today. Then, he makes a compelling case for overhauling our system, offering six elements for inclusion in any plan for change. Davidson devotes the last three chapters to a detailed examination of the politics of reform. This assessment will help readers to appreciate both the political achievement represented by passage of the new law and the reasons that opposition to the law remains so widespread, despite all the good it does for the public. Whatever compromises, if any, are accepted by negotiators in the end, the book makes clear why, to fully solve the system's problems, the underlying goal must be to change incentives for all players who participate in the system and, finally, why this goal cannot be achieved by relying solely on market-based solutions. Davidson's captivating and persuasive book demonstrates that only a solution with a large public-sector role can lead us to real reform.
Still Image and Video Compression with MATLAB
by K. S. ThyagarajanThis book describes the principles of image and video compression techniques and introduces current and popular compression standards, such as the MPEG series. Derivations of relevant compression algorithms are developed in an easy-to-follow fashion. Numerous examples are provided in each chapter to illustrate the concepts. The book includes complementary software written in MATLAB SIMULINK to give readers hands-on experience in using and applying various video compression methods. Readers can enhance the software by including their own algorithms.
Stimulated Brillouin Scattering: Fundamentals and Applications (Series in Optics and Optoelectronics)
by M J Damzen V Vlad Anca Mocofanescu V BabinStimulated Brillouin scattering (SBS) is the most important example of a stimulated scattering process-light scattering that occurs when the intensity of the light field itself affects the propagating medium. A phenomenon that has been known of for some 35 years in solid state laser research, it has recently become relevant in the optical fiber ind
Stimuli-Responsive Dewetting/Wetting Smart Surfaces and Interfaces (Biologically-Inspired Systems #11)
by Atsushi Hozumi Lei Jiang Haeshin Lee Masatsugu ShimomuraSuperhydrophobic surfaces, artificially mimicking lotus leaves, have captured the attention of scientists and engineers over the past few decades. Recent trends have shifted from superhydrophobicity to superominipohobicity, or superamphiphobicity. In addition, dynamic rather than static surface wetting/dewetting properties, which can be triggered by various stimuli, including temperature, pH, magnetic/electric fields, solvents, light exposure etc, have been highly sought after for commercial applications. This book will focus on recent topics related to various stimuli-responsive wetting/dewetting surfaces, and give an overview of the knowledge and concepts of how to design and establish these smart artificial surfaces, which can be used for technical developments in a wide variety research fields.