International Encyclopedia of Ergonomics and Human Factors - 3 Volume Set: Edition 2

2
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The previous edition of the International Encyclopedia of Ergonomics and Human Factors made history as the first unified source of reliable information drawn from many realms of science and technology and created specifically with ergonomics professionals in mind. It was also a winner of the Best Reference Award 2002 from the Engineering Libraries Division, American Society of Engineering Education, USA, and the Outstanding Academic Title 2002 from Choice Magazine. Not content to rest on his laurels, human factors and ergonomics expert Professor Waldemar Karwowski has overhauled his standard-setting resource, incorporating coverage of tried and true methods, fundamental principles, and major paradigm shifts in philosophy, thought, and design. Demonstrating the truly interdisciplinary nature of this field, these changes make the second edition even more comprehensive, more informative, more, in a word, encyclopedic.

Keeping the format popularized by the first edition, the new edition has been completely revised and updated. Divided into 13 sections and organized alphabetically within each section, the entries provide a clear and simple outline of the topics as well as precise and practical information. The book reviews applications, tools, and innovative concepts related to ergonomic research. Technical terms are defined (where possible) within entries as well as in a glossary. Students and professionals will find this format invaluable, whether they have ergonomics, engineering, computing, or psychology backgrounds. Experts and researchers will also find it an excellent source of information on areas beyond the range of their direct interests.
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Publisher
CRC Press
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Published on
Mar 15, 2006
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Pages
3728
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ISBN
9780849375477
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Language
English
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Genres
Business & Economics / General
Technology & Engineering / Engineering (General)
Technology & Engineering / Industrial Health & Safety
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This content is DRM protected.
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Eligible for Family Library

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Packed with illustrations and practical examples, Guide to Methodology in Ergonomics: Designing for Human Use, Second Edition provides a concise introduction to ergonomics methods in a straightforward manner that helps you conduct an ergonomics analysis of a product in development. It details the execution of 12 ergonomics methods that can be applied to the design of any type of product or interface. The authors stress the role of ergonomics in reducing device interaction time and user error while improving user satisfaction and device usability.

See What’s in the New Edition:

Four case studies Addition of another co-author Examples that reflect current technology Information on Critical Path Analysis (CPA)

The authors highlight where ergonomics methods fit in the design process and how to select a method appropriate for your purpose. They describe each method, supplying an overview, instructions on how to carry out an analysis, a mini bibliography, pros and cons, one or more examples, and a flow chart. They then rate each method for reliability/validity, resources, usability, and efficacy. The book then examines data from studies on training, reliability, and validity, and presents an equation that enables you to calculate approximately the financial benefits of using each method.

Based on research and expertise, the book gives you the freedom to be adventurous when choosing methods and the foundation to choose the method that fits the task at hand. Written by experts, it also helps you hone your skills and put the craft of ergonomics into practice.

When faced with a human error problem, you may be tempted to ask 'Why didn't they watch out better? How could they not have noticed?'. You think you can solve your human error problem by telling people to be more careful, by reprimanding the miscreants, by issuing a new rule or procedure. These are all expressions of 'The Bad Apple Theory', where you believe your system is basically safe if it were not for those few unreliable people in it. This old view of human error is increasingly outdated and will lead you nowhere. The new view, in contrast, understands that a human error problem is actually an organizational problem. Finding a 'human error' by any other name, or by any other human, is only the beginning of your journey, not a convenient conclusion. The new view recognizes that systems are inherent trade-offs between safety and other pressures (for example: production). People need to create safety through practice, at all levels of an organization. Breaking new ground beyond its successful predecessor, The Field Guide to Understanding Human Error guides you through the traps and misconceptions of the old view. It explains how to avoid the hindsight bias, to zoom out from the people closest in time and place to the mishap, and resist the temptation of counterfactual reasoning and judgmental language. But it also helps you look forward. It suggests how to apply the new view in building your safety department, handling questions about accountability, and constructing meaningful countermeasures. It even helps you in getting your organization to adopt the new view and improve its learning from failure. So if you are faced by a human error problem, abandon the fallacy of a quick fix. Read this book.
The Handbook of Environmental Health-Biological, Chemical and Physical Agents of Environmentally Related Disease, Volume 1, Fourth Edition includes twelve chapters on a variety of topics basically following a standard chapter outline where applicable with the exception of chapters 1, 2 and 12. The outline is as follows:
1. Background and status
2. Scientific, technological and general information
3. Statement of the problem
4. Potential for intervention
5. Some specific resources
6. Standards, practices, and techniques
7. Modes of surveillance and evaluation
8. Various controls
9. Summary of the chapter
10. Research needs for the future

Chapter 1, Environment and Humans discusses ecosystems, energy technologies and environmental problems, important concepts of chemistry, transport and alteration of chemicals in the environment, environmental economics, risk-benefit analysis, environmental health law, environmental impact statements, competencies for the environmental health practitioner.

Chapter 2, Environmental Problems and Human Health has a general discussion of people and disease followed by a brief discussion of physiology including the human cell, blood, lymphatic system, tissue membranes, nervous system, respiratory system, gastrointestinal system and urinary system. There is a discussion of toxicological principles including toxicokinetics and toxicodynamics. There is a discussion of carcinogenesis, mutagenesis, reproductive toxicity and teratogenesis and the role of environmental contaminants in causing disease. Medical surveillance techniques utilized to measure potential toxicity are included. Basic concepts of microbiology are discussed followed by principles of communicable diseases and emerging infectious diseases. There’s an explanation of epidemiological principles including epidemiological investigations and environmental health and environmental epidemiology. The chapter concludes with a discussion of risk assessment and risk management.

Chapter 3, Food Protection discusses food microbiology, reproduction and growth of microorganisms, environmental effects on bacteria, detergents and disinfectants, sources of foodborne disease exposure, FoodNet, various foodborne infections, bacterial food poisoning, chemical poisoning, poisonous plants and fungi, allergic reactions, parasitic infections, chronic aftereffects of foodborne disease, vessel sanitation programs, food quality protection acts, plans review, food service facilities, food storage, inspection techniques, preparation and serving of food, cleaning and sanitizing equipment and utensils, insect and rodent control, flow systems, epidemiological study techniques, Hazard Analysis and Critical Control Point Inspection, food protection controls, food service training programs, national food safety initiative.

Chapter 4, Food Technology discusses emerging or reemerging foodborne pathogens, chemistry of foods, food additives and preservatives, food spoilage, pesticides and fertilizers in food, antibiotics in food, heavy metals and the food chain, use of recycled plastics in food packaging, environmental problems in milk processing, poultry processing, egg processing, meat processing, fish and shellfish processing, produce processing, and imported foods. National standards, practices and techniques are provided for milk, ice cream, poultry, eggs, meat, produce and seafood. Current modes of surveillance and evaluation as well as appropriate control measures are provided for each of the above areas.

Chapter 5, Insect Control discusses scientific, technological, and general information about various insects of public health significance including fleas, flies, lice, mites, mosquitoes, and roaches. There is a substantial discussion of the many diseases transmitted by insects including African Bite Fever, Bubonic Plague, Chagas Disease, Colorado Tick Fever, Dengue Fever, Ehrlichioses, Encephalitis, Lyme Disease, Malaria, Rickettsial Pox, Rocky Mountain Spotted Fever, Scabies, Scrub Typhus, Tularemia, Typhus Fever, Viral Hemorrhagic Fevers, Yellow Fever. Included in the text are the national standards, practices, and techniques utilized to conduct surveys, methods of prevention and controls of the insects. Further there is a discussion of emerging and reemerging insect borne diseases including why this is occurring. Integrated pest management is a special topic.

Chapter 6, Rodent Control discusses the characteristics and behavior of murine rodents and deer mice, how they affect humans and the various diseases that they cause. National standards, practices and techniques are established for rodent poisoning and trapping, food and harborage removal, and rodent proofing. A special feature is the discussion of an actual working community rodent control program.

Chapter 7, Pesticides discusses current issues, current laws and the effects of pesticides on groundwater, surface water, land, food, air and people. The various categories of pesticides and current allowable usage of inorganic insecticides and petroleum compounds, chlorinated hydrocarbons, organophosphates, carbamates, biolarvicides, and insect growth regulators are discussed.

Chapter 8, Indoor Environment discusses indoor air pollution, housing, health and the housing environment, human illness, monitoring environmental disease, residential wood combustion, environmental tobacco smoke, carbon monoxide, radon gas, volatile organic compounds, asbestos, molds, bacteria and other biological contaminants, environmental lead hazards, noise, accidents and injuries. National standards, practices, and techniques are provided for all areas of the indoor environment, and survey techniques and housing studies are included.

Chapter 9-Institutional Environment discusses the complex environment and potential for disease in nursing and convalescent homes, old-age homes, schools, colleges, and universities, prisons and hospitals. There are in-depth discussions on the potential for spread of disease through air, water, fomites, surfaces, people, food, laundry, insects and rodents, laboratories and biohazards, and surgical suites. Within the hospital setting there are extended discussions of heating, air conditioning, and laminar flow, housekeeping, laundry, solid and hazardous waste, maintenance, plumbing, food, hazardous chemicals, insects and rodents, radioactive materials, water supply, emergency medical services, fire safety and patient safety programs. Handwashing and hospital environmental control is explained in depth including the various microorganisms that may be transmitted by hands. There is a special discussion on laboratories and bio hazards including bacterial agents, fungal agents, parasitic agents, prions, rickettsial agents, viral agents, arborviruses and related zoological viruses. There are additional discussions on human immunodeficiency virus, hepatitis B virus, hepatitis C virus, tuberculosis, resistant organisms. Emerging and reemerging infection problems are of great significance. Hospital acquired infection and routes of transmission are significant problems. Occupational health and safety problems in the hospital are analyzed. The most recent CDC guidelines for all these areas are included. A significant number of inspection and survey forms are included in order for the reader to get a better understanding of specific problems in a specific institution.

Chapter 10-Recreational Environment includes problems and solutions to problems in water quality, water supply, sewage, plumbing, shelter, food, solid waste, fish handling, stables, swimming and boating.

Chapter 11-Occupational Environment includes a discussion of the interrelated challenges of various pressures in the environment. It includes physical agents such as sound, non-ionizing radiation, ionizing radiation, hot and cold temperature extremes. It also includes discussions of chemical agents such as toxic chemicals, flammable chemicals, corrosive chemicals, reactive agents. It includes discussions of biological agents. Ergonomics is an essential part of the chapter. The occupational health controls of substitution, isolation, ventilation, personal protective equipment, housekeeping, and education for control of physical agents, chemical agents, biological agents and ergonomic factors are also discussed.

Chapter 12-Major Instrumentation for Environmental Evaluation of Occupational, Residential, and Public Indoor Settings discusses instantaneous or real-time monitoring, integrated or continuous monitoring, personal monitoring and area monitoring. Techniques and equipment are discussed for various airborne particulates and gaseous agents. Integrated or continuous monitoring of sound as well as instantaneous or real-time monitoring of sound is explained. Evaluation of air temperature factors are discussed. Evaluations of the illumination, microwave radiation, electric and magnetic fields, ionizing radiation, air pressure, velocity and flow rate are presented. Excellent graphics help the reader understand the principles of instrumentation.

A large and current bibliography by chapter is included at the end of the book. This state-of-the-art computerized graphics can be found throughout the book. A comprehensive index of both Volume I and Volume II is at the end of the book to aid the reader in easily finding necessary information. The reader is referred to the Volume II when appropriate.

The book is user-friendly to a variety of individuals including generalalist professionals as well as specialists, industrial hygiene personnel, health and medical personnel, the media, supervisors and managers of environmental health and occupational health areas, and students. Individuals can easily gain appropriate and applicable standards, rules and regulations to help the individual increase knowledge in a given area or solve actual problems. The book is utilized to help individuals also prepare for registration examinations.

The book is co-published with the National Environmental Health Association.
 The science and the art of pharmaceutical formulation keeps

evolving as new materials, methods, and machines become

readily available to produce more reliable, stable, and releasecontrolled

formulations. At the same time, globalization of

sourcing of raw and finished pharmaceuticals brings challenges

to regulatory authorities and results in more frequent

revisions to the current good manufacturing practices, regulatory

approval dossier requirements, and the growing need

for cost optimization. Since the publication of the first edition

of this book, a lot has changed in all of these areas of importance

to pharmaceutical manufacturers. The second edition

builds on the dynamic nature of the science and art of formulations

and provides an evermore useful handbook that

should be highly welcomed by the industry, the regulatory

authorities, as well as the teaching institutions.

The first edition of this book was a great success as it

brought under one umbrella the myriad of choices available

to formulators. The readers were very responsive and communicated

withmefrequently pointing out to the weaknesses

as well as the strengths of the book. The second edition totally

revised attempts to achieve these by making major changes

to the text, some of which include:

1. Complete, revised errors corrected and subject matter

reorganized for easy reference. Whereas this series has

six volumes differentiated on the basis of the type of

dosage form and a separate inclusion of the U.S. OTC

products, ideally the entire collection is needed to benefit

from the myriad of topics relating to formulations,

regulatory compliance, and dossier preparation.

2. Total number of pages is increased from 1684 to 2726.

3. Total number of formulations is expanded by about 30%

with many newly approved formulations.

4. Novel formulations are now provided for a variety of

drugs; these data are collected from the massive intellectual

property data and suggest toward the future trend

of formulations. While some of these formulations may

not have been approved in the United States or Europe,

these do provide additional choices, particularly for the

NDA preparation. As always, it is the responsibility of

the manufacturer to assure that the intellectual property

rights are not violated.

5. A significant change in this edition is the inclusion of

commercial products; while most of this information

is culled out from the open source such as the FOIA

(http://www.fda.gov/foi/default.htm), I have made attempts

to reconstruct the critical portions of it based

on what I call the generally acceptable standards. The

drug companies are advised to assure that any intellectual

property rights are not violated and this applies to

all information contained in this book. The freedom of

information act (FOIA) is an extremely useful conduit

for reliable information and manufacturers are strongly

urged to make use of this information. Whereas this information

is provided free of charge, the process of obtaining

the information may be cumbersome, in which

case, commercial sources of these databases can prove

useful, particularly for the non-U.S. companies.

6. Also included are the new Good Manufacturing Guidelines

(2007) with amendments (2008) for the United States

and similar updates for European Union and WHO; it is

strongly urged that the companies discontinue using all

old documents as there are significant changes in the revised

form, and many of them are likely to reduce the

cost of GMP compliance.

7. Details on design of clean rooms is a new entry that will

be of great use to sterile product manufacturers; whereas

the design and flow of personnel and material flow is of

critical nature, regulatory agencies view these differently

and the manufacturer is advised always to comply with

most stringent requirements.

8. Addition of a self-auditing template in each volume of

the series. While the cGMP compliance is a complex issue

and the requirements diversified across the globe, the

basic compliance remains universal. I have chosen the

European Union guidelines (as these are more in tune

with the ICH) to prepare a self-audit module that I recommend

that every manufacturer adopt as a routine to

assure GMP compliance. In most instances reading the

template by those responsible for compliance with keep

them sensitive to the needs of GMP.

9. OTC products cross-referenced in other volumes where

appropriate. This was necessary since the regulatory authorities

worldwide define this class of drug differently.

It is important to iterate that regardless of the prescription

or the OTC status of a product, the requirements for

compliance with the cGMP apply equally.

10. OTCmonograph status is anew section added to theOTC

volume and this should allow manufacturers to chose appropriate

formulations that may not require a filing with

the regulatory agencies; it is important to iterate that an

approved OTC monograph includes details of formulation

including the types and quantities of active drug and

excipients, labeling, and presentation. To qualify the exemption,

the manufacturer must comply with the monograph

in its entirety. However, subtle modifications that

are merely cosmetic in nature and where there is an evidence

that the modification will not affect the safety and

efficacy of the products can be made but require prior

approval of the regulatory agencies and generally these

approvals are granted.

11. Expanded discussion on critical factors in the manufacturing

of formulations provided; from basic shortcuts

to smart modifications now extend to all dosage forms.

Pharmaceutical compounding is one of the oldest professions

and whereas the art of formulations has been

v

vi Preface to the Series—Second Edition

relegated to more objective parameters, the art nevertheless

remains. An experienced formulator, like an artist,

would know what goes with what and why; he avoids

the pitfalls and stays with conservative choices. These

sections of the book present advice that is time tested,

although it may appear random at times; this is intended

for experienced formulators.

12. Expanded details on critical steps in the manufacturing

processes provided but to keep the size of the book manageable,

and these are included for prototype formulations.

The reader is advised to browse through similar

formulations to gain more insight. Where multiple formulations

are provided for the same drug, it intended to

show the variety of possibilities in formulating a drug

and whereas it pertains to a single drug, the basic formulation

practices can be extended to many drugs of same

class or even of diversified classes. Readers have often

requested that more details be provided in the Manufacturing

Direction sections. Whereas sufficient details are

provided, this is restricted to prototype formulations to

keep the size of the book manageable and to reduce redundancy.

13. Addition of a listing of approved excipients and the level

allowed by regulatory authorities. This new section allows

formulators a clear choice on which excipients to

choose; the excipients are reported in each volume pertaining

to the formulation type covered. The listing is

drawn from the FDA-approved entities. For the developers

of an ANDA, it is critical that the level of excipients be

kept within the range generally approved to avoid large

expense in justifying any unapproved level. The only category

for which the listing is not provided separately is

theOTCvolume since it contains many dosage forms and

the reader is referred to dosage form–specific title of the

series. The choice of excipients forms keeps increasing

with many new choices that can provide many special

release characteristics to the dosage forms. Choosing correct

excipients is thus a tedious exercise and requires sophisticated

multivariate statistical analysis. Whereas the

formulator may choose any number of novel or classical

components, it is important to know the levels of excipients

that are generally allowed in various formulations

to reduce the cost of redundant exercises; I have therefore

included, as an appendix to each volume, a list of all

excipients that are currently approved by the U.S. FDA

along their appropriate levels. I suggest that a formulator

consult this table before deciding on which level of

excipient to use; it does not mean that the excipient cannot

be used outside this range but it obviates the need

for a validation and lengthy justification studies in the

submission of NDAs.

14. Expanded section on bioequivalence submission was

required to highlight the recent changes in these requirements.

New entries include a comprehensive listing

of bioequivalence protocols in abbreviated form as approved

by the U.S. FDA; these descriptions are provided

in each volume where pertinent. To receive approval

for an ANDA, an applicant must generally demonstrate,

among other things, equivalence of the active ingredient,

dosage form, strength, route of administration and

conditions of use as the listed drug, and that the proposed

drug product is bioequivalent to the reference

listed drug [21 USC 355(j)(2)(A); 21 CFR 314.94(a)]. Bioequivalent

drug products show no significant difference in

the rate and extent of absorption of the therapeutic ingredient

[21 U.S.C. 355(j)(8); 21 CFR 320.1(e)]. BE studies are

undertaken in support of ANDA submissions with the

goal of demonstrating BE between a proposed generic

drug product and its reference listed drug. The regulations

governing BE are provided at 21 CFR in part

320. The U.S. FDA has recently begun to promulgate

individual bioequivalence requirements. To streamline

the process for making guidance available to the public

on how to design product-specific BE studies, the

U.S. FDA will be issuing product-specific BE recommendations

(www.fda.gov/cder/ogd/index.htm). To make

this vital information available, an appendix to each

volume includes a summary of all currently approved

products by the U.S. FDA where a recommendation on

conducting bioequivalence studies is made available by

the U.S. FDA. When filing an NDA or an ANDA, the

filer is faced with the choice of defending the methods

used to justify the bioavailability or bioequivalence

data. The U.S. FDA now allows application for waiver

of bioequivalence requirement; a new chapter on this

topic has been added along with details of the dissolution

tests, where applicable, approved for various

dosage forms.

15. Dissolution testing requirements are included for all

dosage forms where this testing is required by the FDA.

Surrogate testing to prove efficacy and compliance is getting

more acceptance at regulatory agencies; in my experience,

a well-designed dissolution test is the best measure

of continuous compliance. Coupled with chapters

on waivers of bioequivalence testing, this information on

dissolution testing should be great value to all manufacturers;

it is recommended that manufacturers develop

their own in-house specifications, more stringent than

those allowed in these listings and the USP.

16. Best-selling products (top 200 prescription products) are

identified with an asterisk and a brand name where applicable;

in all instances, composition of these products is

provided and formulation of generic equivalents. Despite

the vast expansion of pharmaceutical sales and shifting

of categories of blockbuster drugs, basic drugs affecting

gastrointestinal tract, vascular system, and brain remain

most widely prescribed.

17. Updated list of approved coloring agents in the United

States, Canada, European Union, and Japan is included

to allow manufactures to design products for worldwide

distribution.

18. Tablet-coating formulations that meet worldwide requirements

of color selection are included in the Volume

1 (compressed solids) and Volume 5 (OTC) because these

represent the products often coated.

19. Guidelines on preparing regulatory filings are now dispersed

throughout the series depending on where these

guidelines are more crucial. However, the reader would,

as before, need access to all volumes to benefit from the

advice and guidelines provided.

As always, comments and criticism from the readers are

welcomed and these can be sent to me at Niazi@pharmsci

.com or Niazi@niazi.com. I would try to respond to any inquiries

requiring clarification of the information enclosed in

these volumes.

I would like to express deep gratitude to Sherri R. Niziolek

and Michelle Schmitt-DeBonis at Informa, the publisher of

Preface to the Series—Second Edition vii

this work, for seeing an immediate value to the readers in

publishing the second edition of this book and allowing me

enough time to prepare this work. The diligent editing and

composing staff at Informa, particularly Joseph Stubenrauch,

Baljinder Kaur and others are highly appreciated. Regardless,

all errors and omissions remain altogether mine.

In the first edition, I had dedicated each volume to one of

my mentors; the second edition continues the dedication to

these great teachers.

Sarfaraz K. Niazi, Ph.D.

Deerfield, Illinois, U.S.A

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