Environmental

Pharmaceutical Microbiology

The textbook on `Pharmaceutical Microbiology` has been adequately developed and expanded according to the AICTE- Approved Syllabus-2000 meant for the Pharmacy Degree Programme across all the Indian Universities, and others abroad offering similar curricula.

Specific attention has been duly paid to the presentation of each chapter that essentially includes: brief introduction, theoretical aspects, classification, neat and vivid diagrammatic illustrations of figures-graphics-equipments, lucid explanations, supportive classical examples, and profusely supplemented with explanatory`foot notes`-references in addition to further reading bibliography.

The text content runs over ten chapters that may prove to be of paramount interest and enormous readability not only confined to the B.Pharm., students but also to various M.Sc., academic curricula in such disciplines as: Food Microbiology, Environmental Science, Microbiology etc.

Key Features IncludeConcise and exhaustive presentation of scientific informations from several sources.A wealth of theoretical information that opens newer possibilities.Detailed classification of various microbial aspects.Pharmaceutical assays and methodologies.Comprehensive index includes significant terminologies.Well documented statement of facts.

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Air Quality, 4th Edition

Ozone-destroying chemicals, greenhouse gases, and dangerous airborne substances that were once thought to be benign are the most urgent issues facing air pollution control experts. Students need a thorough, updated reference that explores these current trends while also covering the fundamental concepts of this emerging discipline. A new revision of a bestseller, Air Quality, Fourth Edition provides a comprehensive overview air quality issues, including a better understanding of atmospheric chemistry, the effects of pollution on public health and the environment, and the technology and regulatory practices used to achieve air quality goals. New sections cover toxicological principles and risk assessment. The book also contains revised discussions on public policy concerns, with a focus on air quality standards for ozone depletion and global warming, and the health effects of particulate air pollutants. This edition continues to serve as a very readable text for advanced level undergraduate and early graduate study in environmental science, environmental management, and in programs related to the study of public health, industrial hygiene, and pollution control.

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Guidelines for Process Hazards Analysis (PHA, HAZOP), Hazards Identification, and Risk Analysis

This unique manual is a comprehensive, easy-to-read overview of hazards analysis as it applies to the process and allied industries. The book begins by building a background in the technical definition of risk, past industrial incidents and their impacts, ensuing legislation, and the language and terms of the risk field. It addresses the different types of structured analytical techniques for conducting Process Hazards Analyses (PHA), provides a "What If" checklist, and shows how to organize and set up PHA sessions. Other topics include layout and siting considerations, Failure Modes and Effect Analysis (FMEA), human factors, loss of containment, and PHA team leadership issues.

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Statistical Issues in Drug Development

Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will make it invaluable to all those working in drug development and regulation.

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Handbook of Basic Tables for Chemical Analysis, Second Edition

If you are a researcher in organic chemistry, chemical engineering, pharmaceutical science, forensics, or environmental science, you make routine use of chemical analysis. And like its best-selling predecessor was, the Handbook of Basic Tables for Chemical Analysis, Second Edition is your one-stop source for the information needed to design chemical analyses. Here's what is new in the Second Edition:"New chapters on solutions, electroanalytical methods, electrophoresis, and laboratory safety"An expanded section on gas chromatography that includes data on compounds that attack common detectors"New information on detector optimization"An updated section on high performance liquid chromatography that provides the most recent chiral stationary phases, detector information, and revised solvent tables"Updated information on the most useful "wet" chemistry methods"Enlarged section of Miscellaneous Tables Going far beyond the landmark first edition in terms of scope and applications, the second edition provides current and updated data culled from a wide range of resources and consolidated into a concise yet easy-to-use format. The book's laser-like focus on core information gives you the knowledge you need when you need it - at the decision point.

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Passive Sampling Techniques in Environmental Monitoring, Volume 48

Monitoring pollutants in air, soil and water is a routine requirement in the workplace, and in the wider environment. Passive samplers can provide a representative picture of levels of pollutants over a period of time from days to months by measuring the average concentrations to which they have been exposed. Air monitors are widely used, for instance to measure the exposure of workers to volatile compounds, but also for monitoring the fate of pollutants in the atmosphere. Passive sampling devices are now becomining increasingly used to monitor pollutants in rivers, coastal waters and ground water where contamination results from sources such as domestic and industrial discharges, and the use of agrochemicals.
Passive Sampling Techniques in Environmental Monitoring provides a timely collection of information on a set of techniques that help monitor the quality of air, surface and ground waters. Passive sampling can provide an inexpensive means of obtaining a representative picture of quality over a period of time, even where levels of pollutants fluctuate due to discontinuous discharges or seasonal application of chemicals such as pesticides. Recent changes in legislation have increased the pressure to obtain better information than that provided by classical infrequent spot sampling.
Brought together in one source, this book looks at the performance of a range of devices for the passive sampling of metals, and of non-polar and polar organic chemicals in air and in water. The strengths and weaknesses and the range of applicability of the technology are considered.

* Comprehensive review of passive sampling - covering air, water and majority of available technologies in one volume
* Chapters written by international specialist experts
* Covers theory and applications, providing background information and guidelines for use in the field

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Microbial Contamination Control in Parenteral Manufacturing

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

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Contamination and ESD Control in High Technology Manufacturing

A practical "how to" guide that effectively deals with the control of both contamination and ESD

This book offers effective strategies and techniques for contamination and electrostatic discharge (ESD) control that can be implemented in a wide range of high-technology industries, including semiconductor, disk drive, aerospace, pharmaceutical, medical device, automobile, and food production manufacturing. The authors set forth a new and innovative methodology that can manage both contamination and ESD, often considered to be mutually exclusive challenges requiring distinct strategies.

Beginning with two general chapters on the fundamentals of contamination and ESD control, the book presents a logical progression of topics that collectively build the necessary skills and knowledge:

• Analysis methods for solving contamination and ESD problems
• Building the contamination and ESD control environment, including design and construction of cleanrooms and ESD protected environments
• Cleaning processes and the equipment needed to support these processes
• Tooling design and certification
• Continuous monitoring
• Consumable supplies and packaging materials
• Controlling contamination and ESD originating from people
• Management of cleanrooms and ESD protected workplace environments

Contamination and ESD Control in High-Technology Manufacturing conveys a practical, working knowledge of contamination and ESD control strategies and techniques, and it is filled with case studies that illustrate key principles and the benefits of contamination and ESD control. Moreover, its straightforward style makes the material, which integrates many disciplines of engineering and science, clear and accessible.

Written by three leading industry experts, this book is an essential guide for engineers and designers across the many industries where contamination and ESD control is a concern.

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Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

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Controlled Environments - November 2008

BIOLOGICAL SAFETY CABINETS: CONTROLLING CONTAMINATION David Phillips 16

ACHIEVING TRUE EH&S IN CONTROLLED ENVIRONMENTS

Matt Kopecky

CLEANROOM FACILITY CONSTRUCTION OPTIONS

REGULATORY FORUM:

PREDICTING THE FUTURE

Bikash Chatterjee

CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM

THINKING OUTSIDE THE BOX (OR AT LEAST OUTSIDE THE SEM)

Barbara Kanegsberg and Ed Kanegsberg

C4: CRITICAL CLEANING FOR CONTAMINATION CONTROL

MAYBE HEISENBERG WAS WRONG, AND EINSTEIN RIGHT?

John Durkee, Ph.D., P.E 9 EDITOR’S LETTER 25 PRODUCT FOCUS:

INSTRUMENTATION

BUSINESS MARKETPLACE

PENCIL IT IN

ADVERTISER INDEX

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Environmental Risk Assessment

This book gives a broad overview of approaches and experiences on how to assess ecological and human information on health risks. The chapters are targeted to different users. As an example , industrial applications are described, also addressing the need of risk assessments for SMEs. The need of science and policy roles are described. Links to information sources, organisations, software models, EU legislation, and publications are provided.

Gives an overview of approaches and experiences on assessing ecological and human information on health risks.

Industrial applications are described, also addressing the need of risk assessments for SMEs. The needs of science and policy roles are described. Links to information sources, organisations, software models, EU legislation, and publications.

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Industrial Water Quality

The classic guide to controlling industrial water pollution–updated with the latest regulations and new technologies

Turn to the Fourth Edition of Industrial Water Quality for guidance on state-of-the-art methods for optimizing or upgrading existing wastewater treatment systems, as well as selecting the best treatment options to solve specific wastewater problems. This hands-on tool reflects today’s more stringent water-quality regulations and the new technologies developed to meet them. Filled with examples and case studies from a variety of industries, the book covers reverse osmosis or alternative membrane processes and discusses Biological Nutrient Removal (BNR) processes.

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Clean-in-Place for Biopharmaceutical Processes

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.

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Aerosols Handbook: Measurement, Dosimetry, and Health Effects

As more attention is dedicated to understanding the occupational health risks associated with the industrial manufacture and use of nanotechnology, Aerosols Handbook: Measurement, Dosimetry, and Health Effects is a timely presentation of the latest research in the field of aerosol science. The book covers a multitude of topics on indoor, outdoor, and industrial aerosols, including aerosol measurement, deposition, particle size distribution, and biokinetic processes. Where harmful exposure to ultrafine particles may occur through inhalation, dermal contact, and ingestion, this book discusses how the size, shape, and chemical properties of particles affect aerosol deposition in the lungs, possibly other organs, and the overall toxicity. The book covers all relevant aspects of aerosols, from epidemiology to molecular biology, and emphasizes the importance of accurate aerosol measurement. The authors discuss Chernobyl accident and miners' lungs in detail to illustrate the effects of radioactive aerosols. The final section focuses on the health effects of specific aerosols, such as diesel aerosols and ultrafine particles. By converging research from both radioactive and non-radioactive aerosols, the editors give the book a unique and more complete perspective of how aerosols behave in the lungs. Aerosols Handbook: Measurement, Dosimetry, and Health Effects is an essential resource for those who study exposure, dosages, and toxicity to develop treatments for exposure, reduce air pollution, and establish better safety regulations, particularly in industries using nanotechnologies.

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Industrial Water Pollution Control

Theory-to-practice guide to controlling industrial water pollution. In a thoroughly updated new edition that reflects both more stringent regulations and the new technologies developed to meet them, Industrial Water Pollution Control, Third Edition, by W.Wesley Eckenfelder, Jr., introduces you to environmentally-acceptable and cost-effective. state-of- the art methodologies. After an overview of the source and characteristics of industrial wastewaters, you learn about pre- and primary treatment processes...coagulation, precipitation and metals removal...aeration and mass transfer...aerobic biological oxidation and other biological wastewater treatment processes...adsorption...ion exchange...chemical oxidation...sludge handling and disposal...and other processes, including deep-well disposal, membrane process, and more. Specific examples and case histories from a variety of industries, including pulp and paper, chemical and pharmaceutical, textile, food products, and metal finishing, help you understand the application of these technologies to real-world industrial wastewater treatment.

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Pharmaceuticals in the Environment: Sources, Fate, Effects and Risks

The study of pharmaceuticals in the environment as an area of research has only just taken off in recent years. Since the first edition was printed, many research articles on this subject have been published. It is exceedingly difficult for the individual, in particular those not acquainted with the field to establish trends and developments. Even specialists will appreciate this book, as it provides the reader with a well-founded up dated and enlarged overview that addresses the latest findings on the new topics in research.

Following the resounding success of the first two editions, this new edition has been brought up to date and greatly extended. It includes the status of research, paying particular attention to sources and contamination of the environment, substance flows, effects, risk assessment and risk management. In line with the newest developments worldwide there are again contributions from well known and new international authors. This volume also caters for the new requirements confronting European and American researchers since publication of the second edition.

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Environmental Monitoring for Cleanrooms and Controlled Environments

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.

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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries,

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

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CleanRooms - Magazines (Jan 08 to Oct 08)

Magazine of contamination control and clean manufacturing for clean room professionals in the semiconductor, biotechnology, life sciences, and cosmetic manufacturing.

The entire package of the year 2008 from January to September.

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The Aqueous Cleaning Handbook: A Guide to Critical-Cleaning Procedures, Techniques and Validation

This book distills and presents practical information covering the history of aqueous cleaners-- what they are, how they work, and how to make best use of them in cleaning products and components in electronics, metalworking, precision manufacturing, food-and-beverage, pharmaceutical, and chemical processing; and many other industrial applications.

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