Environmental Monitoring For Cleanrooms And Controlled Environments

Author: Anne Marie Dixon
Editor: CRC Press
ISBN: 9781420014853
Size: 14,35 MB
Format: PDF, Mobi
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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: 18,75 MB
Format: PDF, Mobi
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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: 19,38 MB
Format: PDF, ePub
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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

Sterile Drug Products

Author: Michael J. Akers
Editor: CRC Press
ISBN: 1420020560
Size: 12,56 MB
Format: PDF, ePub, Docs
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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Disinfection Sterilization And Preservation

Author: Seymour Stanton Block
Editor: Lippincott Williams & Wilkins
ISBN: 9780683307405
Size: 20,64 MB
Format: PDF, ePub
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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).

Polymorphism In Pharmaceutical Solids Second Edition

Author: H. G. Brittain
Editor: CRC Press
ISBN:
Size: 11,46 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

Endotoxins

Author: Williams Kevin
Editor: Informa Health Care
ISBN: 9780824793623
Size: 14,37 MB
Format: PDF, ePub
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"Describes the environmental presence, detection, properties, and biological structure and function of endotoxins in parenteral manufacturing. Includes assay development, automation, depyrogenation, and regulation of testing by Limulus amebocyte lysate (LAL) methods. Provides expanded coverage of the emergence of nonmicrobial host active bacterial products."

Endotoxins

Author: Kevin L. Williams
Editor: CRC Press
ISBN: 9781420020595
Size: 15,98 MB
Format: PDF, Docs
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This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and expanded, this Third Edition contains the knowledge necessary to apply endotoxin testing in the increasingly complex pharmaceutical environment, featuring sections detailing the latest information regarding clinical advances, regulation standards, and validation procedures for computerized kinetic tests.

Handbook Of Drug Screening Second Edition

Author: Ramakrishna Seethala
Editor: CRC Press
ISBN:
Size: 15,61 MB
Format: PDF, Kindle
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A presentation of screening techniques, modern technologies, and high-capacity instrumentation for increased productivity in the development and discovery of new drugs, chemical compounds, and targeted delivery of pharmaceuticals. It contains practical applications and examples of strategies in cell-based and cell-free screens as well as homogeneous, fluorescence, chemiluminescence, and radioactive-based technologies.

Guide To Microbiological Control In Pharmaceuticals

Author: S. P. Denyer
Editor: Ellis Horwood Limited
ISBN:
Size: 20,47 MB
Format: PDF, ePub, Mobi
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A handbook to the micro-organism as a contaminant and as a potential growth medium, focusing on the problems of microbiological control in pharmaceutical product design and manufacture. Topics include the relative susceptibilities of product types and ingredients and factory hygiene.