Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook

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Author :
Publisher : Bentham Science Publishers
ISBN 13 : 1681081148
Total Pages : 504 pages
Book Rating : 4.6/5 (81 download)

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Book Synopsis Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook by : Jordi Botet

Download or read book Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook written by Jordi Botet and published by Bentham Science Publishers. This book was released on 2015-09-28 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

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Publisher : Elsevier
ISBN 13 : 1908818638
Total Pages : 370 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by : Tim Sandle

Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Hygiene in Food Processing

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Publisher : Elsevier
ISBN 13 : 0857098632
Total Pages : 643 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Hygiene in Food Processing by : H.L.M. Lelieveld

Download or read book Hygiene in Food Processing written by H.L.M. Lelieveld and published by Elsevier. This book was released on 2014-02-14 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt: The hygienic processing of food concerns both potential hazards in food products and the regulation, design, and management of food processing facilities. This second edition of Hygiene in Food Processing gives a revised overview of the practices for safe processing and incorporates additional chapters concerning pest control, microbiological environmental sampling, and the economics of food plants. Part one addresses microbial risks in foods and the corresponding regulation in the European Union. Part two discusses the hygienic design of food factory infrastructure, encompassing the design and materials for the factory itself, as well as food processing equipment. This edition includes a new chapter on the control of compressed gases used to pneumatically operate equipment. Part three focuses on cleaning and disinfection practices in food processing. The chapter on cleaning in place also considers more cost-effective systems, and complements the additional chapter on maintenance of equipment. These chapters also explore issues such as the hygiene of workers, potential infection by foreign bodies, and pest control. Further, the chapter on microbiological sampling explains how to calculate the risk of contamination depending on the product's environment. This essential second edition is useful to professionals responsible for hygiene in the food industry. It provides a comprehensive, yet concise and practical reference source for food plant managers, suppliers of food processing equipment, building contractors, and food inspectors looking for an authoritative introduction to hygiene regulation, hygienic design, and sanitation. - Provides a revised overview of the practices for safe processing - Incorporates additional chapters concerning pest control, microbiological environmental sampling, and the economics of food plants - This essential second edition is useful for professionals responsible for hygiene in the food industry

Air Conditioning – Energy Consumption and Environmental Quality

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Author :
Publisher : EOLSS Publications
ISBN 13 : 1848261691
Total Pages : 396 pages
Book Rating : 4.8/5 (482 download)

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Book Synopsis Air Conditioning – Energy Consumption and Environmental Quality by : Matheos Santamouris

Download or read book Air Conditioning – Energy Consumption and Environmental Quality written by Matheos Santamouris and published by EOLSS Publications. This book was released on 2009 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Air Conditioning - Energy Consumption and Environmental Quality theme is the component of Encyclopedia of Energy Sciences, Engineering and Technology Resources in the global Encyclopedia of Life Support Systems (EOLSS), which is an integrated compendium of twenty one Encyclopedias. The book on Air Conditioning - Energy Consumption and Environmental Quality in the Encyclopedia of Energy Sciences, Engineering and Technology Resources considers the following topics on Systems and Equipment for Space Heating, Ventilation Systems, Air conditioning and Refrigeration and Cryogenic Systems. This volume is aimed at the following five major target audiences: University and College Students, Educators, Professional Practitioners, Research Personnel and Policy Analysts, Managers, and Decision Makers and NGOs.

Handbook of Nonwovens

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Publisher : Woodhead Publishing
ISBN 13 : 0128189134
Total Pages : 650 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Handbook of Nonwovens by : S. J. Russell

Download or read book Handbook of Nonwovens written by S. J. Russell and published by Woodhead Publishing. This book was released on 2022-05-31 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Nonwovens, Second Edition updates and expands its popular interdisciplinary treatment of the properties, processing, and applications of nonwovens. Initial chapters review the development of the industry and the different classes of nonwoven material. The book then discusses methods of manufacture such as dry-laid, wet-laid, and polymer-laid web formation. Other techniques analyzed include mechanical, thermal, and chemical bonding, as well as chemical and mechanical finishing systems. The book concludes by assessing the characterization, testing, and modeling of nonwoven materials.Covering an unmatched range of materials with a variety of compositions and manufacturing routes, this remains the indispensable reference to nonwovens for designers, engineers, materials scientists, and researchers, particularly those interested in the manufacturing of automotive, aerospace, and medical products. Nonwovens are a unique class of textile material formed from fibers that are bonded together through various means to form a coherent structure. The range of properties they can embody make them an important part of a range of innovative products and solutions, which continues to attract interest from industry as well as academia. - Describes in detail the manufacturing processes of a range of nonwoven materials - Provides detailed coverage of the mechanical and thermal properties of non-woven fabrics - Includes extensive updates throughout on the characterization and testing of nonwovens - Explains how to model nonwoven structures

Perry's Chemical Engineers' Handbook, 9th Edition

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Publisher : McGraw Hill Professional
ISBN 13 : 0071834095
Total Pages : 2274 pages
Book Rating : 4.0/5 (718 download)

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Book Synopsis Perry's Chemical Engineers' Handbook, 9th Edition by : Don W. Green

Download or read book Perry's Chemical Engineers' Handbook, 9th Edition written by Don W. Green and published by McGraw Hill Professional. This book was released on 2018-07-13 with total page 2274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Up-to-Date Coverage of All Chemical Engineering Topics―from the Fundamentals to the State of the Art Now in its 85th Anniversary Edition, this industry-standard resource has equipped generations of engineers and chemists with vital information, data, and insights. Thoroughly revised to reflect the latest technological advances and processes, Perry's Chemical Engineers' Handbook, Ninth Edition, provides unsurpassed coverage of every aspect of chemical engineering. You will get comprehensive details on chemical processes, reactor modeling, biological processes, biochemical and membrane separation, process and chemical plant safety, and much more. This fully updated edition covers: Unit Conversion Factors and Symbols • Physical and Chemical Data including Prediction and Correlation of Physical Properties • Mathematics including Differential and Integral Calculus, Statistics , Optimization • Thermodynamics • Heat and Mass Transfer • Fluid and Particle Dynamics *Reaction Kinetics • Process Control and Instrumentation• Process Economics • Transport and Storage of Fluids • Heat Transfer Operations and Equipment • Psychrometry, Evaporative Cooling, and Solids Drying • Distillation • Gas Absorption and Gas-Liquid System Design • Liquid-Liquid Extraction Operations and Equipment • Adsorption and Ion Exchange • Gas-Solid Operations and Equipment • Liquid-Solid Operations and Equipment • Solid-Solid Operations and Equipment •Chemical Reactors • Bio-based Reactions and Processing • Waste Management including Air ,Wastewater and Solid Waste Management* Process Safety including Inherently Safer Design • Energy Resources, Conversion and Utilization* Materials of Construction

High Efficiency Air Filters (EPA, HEPA and ULPA). Aerosol Production, Measuring Equipment, Particle Counting Statistics

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Author :
Publisher :
ISBN 13 : 9780580617911
Total Pages : 30 pages
Book Rating : 4.6/5 (179 download)

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Book Synopsis High Efficiency Air Filters (EPA, HEPA and ULPA). Aerosol Production, Measuring Equipment, Particle Counting Statistics by : British Standards Institute Staff

Download or read book High Efficiency Air Filters (EPA, HEPA and ULPA). Aerosol Production, Measuring Equipment, Particle Counting Statistics written by British Standards Institute Staff and published by . This book was released on 1910-01-31 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: Air filters, Air cleaning equipment, Filters, Efficiency, Air-conditioning systems, Ventilation, Clean rooms, Aerosols, Dispersions (chemical), Performance testing, Particle size measurement, Measuring instruments, Test equipment, Physical property measurement, Classification systems, Specimen preparation, Error correction, Calibration, Maintenance, Inspection, Accuracy, Pressure testing, Humidity measurement, Statistical methods of analysis

High Efficiency Air Filters (HEPA and ULPA). Aerosol Production, Measuring Equipment, Particle Counting Statistics

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Author :
Publisher :
ISBN 13 : 9780580298387
Total Pages : 20 pages
Book Rating : 4.2/5 (983 download)

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Book Synopsis High Efficiency Air Filters (HEPA and ULPA). Aerosol Production, Measuring Equipment, Particle Counting Statistics by : British Standards Institute Staff

Download or read book High Efficiency Air Filters (HEPA and ULPA). Aerosol Production, Measuring Equipment, Particle Counting Statistics written by British Standards Institute Staff and published by . This book was released on 1998-11 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Air filters, Air cleaning equipment, Filters, Efficiency, Air-conditioning systems, Ventilation, Clean rooms, Aerosols, Dispersions (chemical), Performance testing, Particle size measurement, Measuring instruments, Test equipment, Density, Melting point, Viscosity, Boiling point, Vapour pressure, Refractive index, Condensation, Physical property measurement, Classification systems, Specimen preparation, Error correction, Calibration, Maintenance, Inspection, Accuracy, Pressure testing, Humidity measurement, Statistical methods of analysis, Bibliography

Aerosol Science and Technology

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Publisher : RTI Press
ISBN 13 : 1934831018
Total Pages : 584 pages
Book Rating : 4.9/5 (348 download)

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Book Synopsis Aerosol Science and Technology by : David S. Ensor

Download or read book Aerosol Science and Technology written by David S. Ensor and published by RTI Press. This book was released on 2011-10-06 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aerosol Science and Technology: History and Reviews captures an exciting slice of history in the evolution of aerosol science. It presents in-depth biographies of four leading international aerosol researchers and highlights pivotal research institutions in New York, Minnesota, and Austria. One collection of chapters reflects on the legacy of the Pasadena smog experiment, while another presents a fascinating overview of military applications and nuclear aerosols. Finally, prominent researchers offer detailed reviews of aerosol measurement, processes, experiments, and technology that changed the face of aerosol science. This volume is the third in a series and is supported by the American Association for Aerosol Research (AAAR) History Working Group, whose goal is to produce archival books from its symposiums on the history of aerosol science to ensure a lasting record. It is based on papers presented at the Third Aerosol History Symposium on September 8 and 9, 2006, in St. Paul, Minnesota, USA.

Quality Assurance of Aseptic Preparation Services

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Publisher :
ISBN 13 : 9780857113078
Total Pages : 0 pages
Book Rating : 4.1/5 (13 download)

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Book Synopsis Quality Assurance of Aseptic Preparation Services by : Alison M. Beaney

Download or read book Quality Assurance of Aseptic Preparation Services written by Alison M. Beaney and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.

Handbook of Air Conditioning and Refrigeration

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Publisher : McGraw Hill Professional
ISBN 13 :
Total Pages : 1430 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Handbook of Air Conditioning and Refrigeration by : Shan K. Wang

Download or read book Handbook of Air Conditioning and Refrigeration written by Shan K. Wang and published by McGraw Hill Professional. This book was released on 2000-11-07 with total page 1430 pages. Available in PDF, EPUB and Kindle. Book excerpt: * A broad range of disciplines--energy conservation and air quality issues, construction and design, and the manufacture of temperature-sensitive products and materials--is covered in this comprehensive handbook * Provide essential, up-to-date HVAC data, codes, standards, and guidelines, all conveniently located in one volume * A definitive reference source on the design, selection and operation of A/C and refrigeration systems

Gas Turbines for Electric Power Generation

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Publisher : Cambridge University Press
ISBN 13 : 1108416659
Total Pages : 735 pages
Book Rating : 4.1/5 (84 download)

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Book Synopsis Gas Turbines for Electric Power Generation by : S. Can Gülen

Download or read book Gas Turbines for Electric Power Generation written by S. Can Gülen and published by Cambridge University Press. This book was released on 2019-02-14 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: Everything you wanted to know about industrial gas turbines for electric power generation in one source with hard-to-find, hands-on technical information.

Fluid Filtration: Gas

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Publisher : ASTM International
ISBN 13 : 0803109458
Total Pages : 436 pages
Book Rating : 4.8/5 (31 download)

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Book Synopsis Fluid Filtration: Gas by : Robert R. Raber

Download or read book Fluid Filtration: Gas written by Robert R. Raber and published by ASTM International. This book was released on 1986 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Nonwoven Fabrics

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Publisher : John Wiley & Sons
ISBN 13 : 3527605312
Total Pages : 772 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Nonwoven Fabrics by : Wilhelm Albrecht

Download or read book Nonwoven Fabrics written by Wilhelm Albrecht and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 772 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the utilization of textile waste to the high-tech product - this is how modern nonwovens can best described. Web formation and web bonding processes have recently being enhanced. Nowadays, fibres, granulates, binder and finishing agents are used. This development entails a wider range of applications in the fields of hygiene, medicine, the garment-producing and building industries, interior design as well as further technical uses. This book provides comprehensive information about nonwovens, from the raw material fibres via the manufacturing processes to finishing and to the ready-made product. Nonwoven characteristics and the fields of application are discussed in detail as well as the processes available to test the raw materials, the intermediate and the final products. This book will be the standard reference on nonwovens in the years to come!

Aerosol Filtration

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Publisher : Elsevier
ISBN 13 : 008102116X
Total Pages : 228 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Aerosol Filtration by : Dominique Thomas

Download or read book Aerosol Filtration written by Dominique Thomas and published by Elsevier. This book was released on 2016-11-30 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Filtration of aerosols is omnipresent in our daily lives, in areas as diverse as health, the protection of people and the environment, and air treatment inside buildings. However, the collection of particles within a filter media is not, contrary to popular belief, linked to a simple screen effect. The phenomena involved are much more complex and require the consideration of aerosol interactions, filter media and process conditions to select the best fiber filter for a given application. Aerosol Filtration, book for students, hygiene or process engineers, fibrous media manufacturers, designers, and filtration system suppliers or users addresses the filtration of aerosols in six chapters. These chapters cover physics and aerosol characterization, the fibrous media, and efficiency and filter clogging by solid or liquid aerosols, with special attention to the filtration of the nanoparticles. - Analyses the behavior of fibrous media against solid and liquid aerosols - Presents models of efficiency and pressure drop - Introduces computing elements for estimating the lifetime of filters - Provides guidance for designing filters and predicting their behavior over time

Containment Technology

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Publisher : Springer Science & Business Media
ISBN 13 : 364239292X
Total Pages : 176 pages
Book Rating : 4.6/5 (423 download)

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Book Synopsis Containment Technology by : Hans-Jürgen Bässler

Download or read book Containment Technology written by Hans-Jürgen Bässler and published by Springer Science & Business Media. This book was released on 2013-10-01 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.

Indoor Air Quality Engineering

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Publisher : CRC Press
ISBN 13 : 1566706742
Total Pages : 642 pages
Book Rating : 4.5/5 (667 download)

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Book Synopsis Indoor Air Quality Engineering by : Yuanhui Zhang

Download or read book Indoor Air Quality Engineering written by Yuanhui Zhang and published by CRC Press. This book was released on 2004-08-30 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: Indoor Air Quality Engineering covers a wide range of indoor air quality engineering principles and applications, providing guidelines for identifying and analyzing indoor air quality problems as well as designing a system to mitigate these problems. Structured into three sections - properties and behavior of airborne pollutants, measurement and sampling efficiency, and air quality enhancement technologies - this book uses real-life examples, design problems, and solutions to illustrate engineering principles. Professionals and students in engineering, environmental sciences, public health, and industrial hygiene concerned with indoor air quality control will find Indoor Air Quality Engineering provides effective methods, technologies, and principles not traditionally covered in other texts.