Pharmaceutical Engineering Change Control

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

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Isolation Technology: A Practical Guide, Second Edition

The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: " Descriptions of and comments on new guidelines and standards " Technological advances - such as the new breed of sanitizing gas generators " Updates that reflect current thinking and new information Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.

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Applications of Hydrogen Peroxide and Derivatives: (RSC Clean Technology Monographs)

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Cleanroom Technology: Fundamentals of Design, Testing and Operation

A cleanroom is a contamination-controlled environment and is essential in the industrial manufacture of many electronic, semiconductor, optical, pharmaceutical and medical products.

The use of cleanrooms for the manufacture of a large range of products such as microprocessors, CD players, lasers, pharmaceuticals and medical devices continues to grow and many companies are using cleanrooms for the first time. At the same time, new technology products that can only be produced in cleanrooms are being developed. This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with a introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards. Readers will benifit from the author's 35 years of experience in cleanroom technology R&D, consultancy and teaching. The text is complementary to the structure and content of Whyte's own and many in-house cleanroom courses in the electronics and pharmaceutical industries.
· Complementary to the highly successful Cleanroom Design, Second Edition and the forthcoming Cleanroom Testing and Running by the same author
· Presents the fundamentals and latest standards for the design, validation, testing and running of cleanroom systems
Pitched at introductory level and tailored to fulfil the training requirements of scientists and engineers new to cleanroom technology

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Facility Validation: Theory, Practice, and Tools

Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and coverage of best practices for evaluating validation programs.

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Injectable Dispersed Systems: Formulation, Processing and Performance

This authoritative guide will serve as the most current source on the design and manufacturing of parenteral dispersed systems-showcasing the utility of dispersed systems in drug delivery, drug targeting, and pharmaceutical engineering.

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Refrigeration and Air Conditioning, Third Edition

The use of refrigeration, either directly or as part of an air-conditioning system, is essential to almost every branch of industry.

There is a need for practitioners to familiarise themselves with the general principles and methods of refrigeration and air conditioning, and the types of plant and operation currently in use.

This book provides a comprehensive introduction to the principles and practice of refrigeration and air-conditioning for the uninitiated student and a general overview of the industry for the practitioner. The fundamentals of the subject are introduced without involving the reader too deeply in theory and the content is presented in a logical order.

This fully revised and updated third edition has a new chapter on Refrigerants that deals with the many changes in this area over the last 10 years, including the phase out of CFC and HCFC refrigerants in line with Ozone depletion and Global Warming. New, replacement refrigerants are described, together with Codes of Practice introduced for maintenance and servicing of refrigeration plants. The increased use of Ammonia and Propane are included, with the relevant Health and Safety aspects, and the move towards Absorption refrigeration equipment as more environmentally friendly.

This new edition of Refrigeration and Air Conditioning is a valuable reference source for practising engineers and essential reading for students.

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Handbook of Water and Wastewater Treatment Technologies, First Edition

This Handbook is an authoritative reference for process and plant engineers, water treatment plant operators and environmental consultants. Practical information is provided for application to the treatment of drinking water and to industrial and municipal wastewater. The author presents material for those concerned with meeting government regulations, reducing or avoiding fines for violations, and making cost-effective decisions while producing a high quality of water via physical, chemical, and thermal techniques.

Included in the texts are sidebar discussions, questions for thinking and discussing, recommended resources for the reader, and a comprehensive glossary.

Two companion books by Cheremisinoff are available:
Handbook of Air Pollution Control Technologies, and Handbook of Solid Waste Management and Waste Minimization Technologies.

* Covers the treatment of drinking water as well as industrial and municipal wastewater
* Cost-efficiency considerations are incorporated in the discussion of methodologies
* Provides practical and broad-based information in one comprehensive source

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Water Quality Systems, 2nd Edition, Revised and Expanded

An excellent guide for anyone with a water system or water system problem, this book provides an A-Z reference for improving water quality, meeting new regulations, and reducing costs. Every page contains a time saving, money saving tip. The book covers water purity, renovations, design, construction, equipment, systems, cost reduction, maintenance and more. Also included is the latest information on EPA's WAVE Saver program for the hotel/motel industry, and coverage of other regulations and codes. The book is designed to make the information easy to find for the busy manager or professional who doesn't have time wade through pages and pages of textbook approaches.

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Facilities Management Handbook, Third Edition

The world of facilities management has changed dramatically in recent years. From humble beginnings it is now a fully-fledged professional discipline cover a wide range of challenging roles that go right to the heart of business success.

The Facilities Management Handbook gives a complete and comprehensive guide to the different aspects of the Facility Manager's role, from compliance with health and safety law through risk management to getting the most out of buildings and space.

The Handbook provides checklists and practical guidance that ensures that the Facilities Manager can meet the increasingly complex demands of their profession.

* Wealth of information available in an easily accessible and readable format

* Enables managers to keep abreast of all key facts required in the day-to-day running of a business

* Offers a concise encyclopaedia on all facilities management issues, combining best practice tips with proactive legal advice

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Fundamentals of Preventive Maintenance

"Plant engineers and maintenance managers know from experience: All manufacturing equipment will break down, often at the worst possible moment. To survive in today's lean-and-mean manufacturing environment, companies must head off these breakdowns with a preventive-maintenance management program that is both systematic and flexible -- and geared toward minimizing downtime and maximizing equipment life. Fundamentals of Preventive Maintenance provides readers with an easy-to-follow, economically sensible maintenance and workorder management program. This results-driven guidebook outlines a 7-step process for designing and implementing the program, describing what needs to be done -- and why. Designed to transform an often unwieldy program into one that can be effectively managed, it provides hands-on techniques for: * Establishing critical scheduling protocols * Managing the daily workorder schedule * Developing and issuing preventive maintenance workorders * Monitoring the program and making improvements"

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Pharmaceutical Experimental Design

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.


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HVAC Inspection Notes: Up to Code

Up to Code: HVAC Inspection Notes is an on-the-job “cliff notes” resource, packed with information that will save time and money while ensuring quality. To-do checklists, charts and tables with at-a-glance calculations, who’s-responsible-for-what info, and diagrams that clearly illustrate complicated information make it fast and easy for busy building professionals to do their jobs thoroughly and efficiently, and avoid costly mistakes. The books help building pros establish and meet inspection guidelines, and provide clients with schedules and specifications. Each of the Up to Code: Inspection Notes is focused on the IBC (International Building Code), the most widely adopted building code in North America. HVAC will also focus on information from the SMACNA Duct Manual. Each guide covers: Responsibility; Authority; Quality Control and Assurance; Plans and Specifications; Shop Drawings; Inspectors Daily Report; Pre-Construction Meeting; Equipment Proposal; Claims; Progress Schedules; Labor Enforcement; Storage of Materials; Contractor’s Payment; Rights-of-Way; Record Drawings; Project Turnover; Inspection Files; Recommended Equipment; Inspection; Safety.



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Indoor Air Quality Handbook

* Tackles the complex environmental issue of Indoor Air Quality (IAQ) for industrial hygienists, HVAC engineers, architects and anyone else concerned with the air quality of interiors
* Infused with charts, tables, and all the major formulas and calculations necessary to monitor and characterize a particular environment
* Includes all relevant codes, standards and guidelines

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Handbook for Critical Cleaning: Aqueous, Solvent, Advanced Processes,Surface Preparation, and Contamination Control

With all the cleaning approaches available, how do you choose which one is best for your needs? Components manufacturers wonder which will provide a competitive edge. Chemists and engineers worry about the effect of any process modification on a critical component or on the stability of an irreplaceable antique. There is no silver bullet, no magic drop-in solution. The best approach is application specific and often location specific. Handbook for Critical Cleaning provides the tools you need to select the best approach in a rapidly changing world. Rigorous in its treatment of technical issues, broad in scope, and clearly written, the book includes cleaning agent options, cleaning systems/chemical and equipment integration, contamination control, cleanliness standards, analytical testing, process selection, implementation, and maintenance, specific applications areas, and regulatory considerations and outlook. Cleaning, which was once a simple decision among a few cleaning agents and types of equipment, is now recognized as a major factor in process control and product improvement. Choosing the best process involves an understanding of chemistry, engineering, safety and regulatory requirements, as well as a realistic assessment of the strengths and limitations of the local workforce. Handbook for Critical Cleaning shows you not only what processes are available and how to evaluate them, but how to customize cleaning procedures to meet your needs.

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HVAC Systems and Components Handbook

With this authoritative reference at hand, engineers and technicians will gain full knowledge of each component in today Õs complex heating, ventilating, and air conditioning systems. Completely revised and fully updated, this second edition of a widely used working tool offers: Analyses of today Õs most efficient, most trouble-free systems ... Details on todays highly advanced components ... Ways to achieve economy and efficiency in design ... clear explanations of the environmental impact of HVAC design ... Information on meeting key codes and standards. Featuring contributions from the top companies in HVAC technology ÑYork, Allied Signal, Honeywell, and SverdrupÑthe Handbook is an ideal source of reliable and timely information and advice on HVAC systems and components.

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Laboratory Design, Construction, and Renovation: Participants, Process, and Product

Laboratory facilities are complex, technically sophisticated, and mechanically intensive structures that are expensive to build and to maintain. Hundreds of decisions must be made before and during new construction or renovation that will determine how successfully the facility will function when completed and how successfully it can be maintained once put into service.

This book provides guidance on effective approaches for building laboratory facilities in the chemical and biochemical sciences. It contains both basic and laboratory-specific information addressed to the user community-the scientists and administrators who contract with design and construction experts. The book will also be important to the design and construction communities-the architects, laboratory designers, and engineers who will design the facility and the construction personnel who will build it-to help them communicate with the scientific community for whom they build laboratory facilities.

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Analysis, Fate and Removal of Pharmaceuticals in the Water Cycle

Pharmaceutically active substances are a class of new, so-called "emerging" contaminants that have raised great concern in recent years. Human and veterinary drugs are constantly being introduced into the environment, mainly as a result of the manufacturing process. Over a period of time, this level of chemical input may lead to long-term concentrations and promote continual, but unnoticed adverse effects on aquatic and terrestrial organisms. Analysis, Fate and Removal of Pharmaceuticals in the Water Cycle discusses state-of-the-art analytical methods for trace determination of pharmaceuticals in environmental samples while reviewing the fate and occurrence of pharmaceuticals in the water cycle (elimination in wastewater and drinking water treatment). Focus is given to the newest developments in the treatment technologies, such as membrane bioreactors and advance oxidation processes.

* Well-structured overview of latest developments in trace determination
* Concise and critical compilation of literature published over the last few years
* Focuses on new treatment technologies, such as membrane bioreactors and advance oxidation processes

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Pharmaceutical Process Engineering

Summarizing fundamental engineering principles and operations critical to converting bulk pharmaceutical products into patient-ready and appropriate drug delivery dosage forms, Pharmaceutical Process Engineering facilitates comprehensive understanding of the practical aspects of drug production in an accessible, step-by-step format. It provides a pharmaceutical perspective on unit operations that improves communication among diverse professionals in the field-from pharmaceutical researchers to chemical and industrial engineers-and fully covers the relationship of pharmaceutical development to the application of key concepts and major unit operations in pharmaceutical engineering.

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Handbook of Water Analysis, Second Edition

Extensively revised and updated, Handbook of Water Analysis, Second Edition provides the most current analytical techniques for detecting compounds in water samples. Maintaining the detailed and accessible style of the original, this edition demonstrates water sampling and preservation methods by enumerating different ways to measure chemical and radiological characteristics and giving step-by-step descriptions of separation, residue determination, and clean-up techniques for a variety of fresh- and salt-water. It reveals new information regarding the analysis of endocrine disrupting compounds and residues of plastics as well as four new chapters on acrylamide, trihalomethanes, phthalates, and volatile organic compounds in water.

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