Environmental Monitoring For Cleanrooms And Controlled Environments

Author: Anne Marie Dixon
Editor: CRC Press
ISBN: 9781420014853
Size: 19,20 MB
Format: PDF, ePub
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A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.

Buildings For Advanced Technology

Author: Ahmad Soueid
Editor: Springer
ISBN: 3319248928
Size: 16,67 MB
Format: PDF, Docs
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This book deals with the design and construction of buildings for nanoscale science and engineering research. The information provided in this book is useful for designing and constructing buildings for such advanced technologies as nanotechnology, nanoelectronics and biotechnology. The book outlines the technology challenges unique to each of the building environmental challenges outlined below and provides best practices and examples of engineering approaches to address them: • Establishing and maintaining critical environments: temperature, humidity, and pressure • Structural vibration isolation • Airborne vibration isolation (acoustic noise) • Isolation of mechanical equipment-generated vibration/acoustic noise • Cost-effective power conditioning • Grounding facilities for low electrical interference • Electromagnetic interference (EMI)/Radio frequency interference (RFI) isolation • Airborne particulate contamination • Airborne organic and chemical contamination • Environment, safety and health (ESH) considerations • Flexibility strategies for nanotechnology facilities The authors are specialists and experts with knowledge and experience in the control of environmental disturbances to buildings and experimental apparatus.

Biocontamination Control For Pharmaceuticals And Healthcare

Author: Tim Sandle
Editor: Academic Press
ISBN: 0128149124
Size: 19,65 MB
Format: PDF, Docs
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Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Disinfection Sterilization And Preservation

Author: Seymour Stanton Block
Editor: Lippincott Williams & Wilkins
ISBN: 9780683307405
Size: 19,84 MB
Format: PDF, Kindle
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This new edition is a comprehensive, practical reference on contemporary methods of disinfection, sterlization, and preservation and their medical, surgical, and public health applications. New topics covered include recently identified pathogens, microbial biofilms, use of antibiotics as antiseptics, synergism between chemical microbicides, pulsed-light sterilization of pharmaceuticals, and new methods for medical waste management. (Midwest).

Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition

Author: Stephen P. Denyer
Editor: CRC Press
ISBN: 9781420021622
Size: 13,54 MB
Format: PDF, Kindle
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Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.

Advances In Data Mining

Author: Petra Perner
Editor: Springer Science & Business Media
ISBN: 9783540240549
Size: 19,57 MB
Format: PDF
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The Industrial Conference on Data Mining ICDM-Leipzig was the fourth meeting in a series of annual events which started in 2000, organized by the Institute of Computer Vision and Applied Computer Sciences (IBaI) in Leipzig. The mission of the conference is to bring together researchers and people from industry in order to discuss together new trends and applications in data mining. This year a broad spectrum of work of different applications was presented ranging from image mining, medicine and biotechnology, management and environmental control, to telecommunications. Besides that an industrial exhibition showed the successful application of data mining methods by industries in different areas such as medical devices, mass data management systems, data mining tools, etc. During the discussion many projects were inspired leading to new and joint work. The fruitful discussions, the exchange of ideas and the spirit of the conference made it a remarkable event for both sides, industry and research. We would like to express our appreciation to the reviewers for their precise and highly professional work. We appreciate the help and understanding of the editorial staff at Springer and in particular Alfred Hofmann, who supported the publication of these proceedings in the LNAI series. Last, but not least, we wish to thank all speakers, participants and industrial exhibitors who contributed to the success of the conference. We are looking forward to welcoming you to ICDM 2005 (www.data-mini- forum.de) and to the new work you will present there.

Particle Adhesion And Removal

Author: K. L. Mittal
Editor: John Wiley & Sons
ISBN: 1118831543
Size: 18,31 MB
Format: PDF, ePub, Docs
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The book provides a comprehensive and easily accessiblereference source covering all important aspects of particleadhesion and removal. The core objective is to cover bothfundamental and applied aspects of particle adhesion and removalwith emphasis on recent developments. Among the topics to be covered include: 1. Fundamentals of surface forces in particle adhesion andremoval. 2. Mechanisms of particle adhesion and removal. 3. Experimental methods (e.g. AFM, SFA,SFM,IFM, etc.) tounderstand particle-particle and particle-substrateinteractions. 4. Mechanics of adhesion of micro- and nanoscaleparticles. 5. Various factors affecting particle adhesion to a variety ofsubstrates. 6. Surface modification techniques to modulate particleadhesion. 7. Various cleaning methods (both wet & dry) for particleremoval. 8. Relevance of particle adhesion in a host of technologies rangingfrom simple to ultra-sophisticated.

Remington S Pharmaceutical Sciences

Author: Joseph Price Remington
Editor:
ISBN:
Size: 13,90 MB
Format: PDF
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Intrathecal Drug Delivery For Pain And Spasticity E Book

Author: Asokumar Buvanendran
Editor: Elsevier Health Sciences
ISBN: 1455733989
Size: 13,74 MB
Format: PDF, ePub, Docs
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Intrathecal Drug Delivery for Pain and Spasticity - a volume in the new Interventional and Neuromodulatory Techniques for Pain Management series - presents state-of-the-art guidance on the full range of intrathecal drug delivery techniques performed today. Asokumar Buvanendran, MD and Sudhir Diwan, MD, offer expert advice on a variety of procedures to treat chronic non-malignant pain, cancer pain, and spasticity. Comprehensive, evidence-based coverage on selecting and performing these techniques - as well as weighing relative risks and complications - helps you ensure optimum outcomes. Understand the rationale and scientific evidence behind intrathecal drug delivery techniques and master their execution. Optimize outcomes, reduce complications, and minimize risks by adhering to current, evidence-based practice guidelines. Apply the newest techniques in intrathecal pump placement, cancer pain management, use of baclofen pumps, and compounding drugs. Quickly find the information you need in a user-friendly format with strictly templated chapters supplemented with illustrative line drawings, images, and treatment algorithms.

Polymorphism In Pharmaceutical Solids Second Edition

Author: H. G. Brittain
Editor: CRC Press
ISBN:
Size: 12,73 MB
Format: PDF, ePub, Mobi
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Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism and solvatomorphism, while systematically explaining their thermodynamic and structural origins. Topics include: Computational methodologies High-throughput screening methods Pharmaceutical cocrystals Thermally-induced and solution-mediated phase transformations Amorphous solids Crystallography preparation and characterization The amorphous state