the print and packaging buying handbook

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The Print And Packaging Buying Handbook

Author : Alan Jamieson
ISBN : 1857130308
Genre : Multimedia systems
File Size : 67. 74 MB
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Buying print and packaging has become an increasingly complex and competitive business yet few people who are print and packaging buyers - often commanding large budgets - are trained in the skills needed to negotiate the right quality at the right price. The handbook sets out exactly what the buyer needs to know from text to repro to proofing, printing and finishing, matching process to product. Its practical approach includes sample specifications, estimate requests, quotations and schedules; it provides troubleshooting checklists for when things go wrong and presents each aspect in an accessible format for easy reference and understanding. An extra section on buying multimedia is included for those responsible also for purchasing hardware and software and multimedia products for their companies.

Handbook Of Paper And Paperboard Packaging Technology

Author : Mark J. Kirwan
ISBN : 9781118470923
Genre : Technology & Engineering
File Size : 81. 82 MB
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The definitive industry reference on the paper and paperboard packaging sector. Now in a fully revised and updated second edition, this book discusses all the main types of packaging based on paper and paperboard. It considers the raw materials, the manufacture of paper and paperboard, and the basic properties and features on which packaging made from these materials depends for its appearance and performance. The manufacture of twelve types of paper- and paperboard-based packaging is described, together with their end-use applications and the packaging machinery involved. The importance of pack design is stressed, as well as how these materials offer packaging designers opportunities for imaginative and innovative design solutions. Environmental factors, including resource sustainability, societal and waste management issues are addressed in a dedicated chapter. The book is directed at readers based in companies which manufacture packaging grades of paper and paperboard, companies involved in the design, printing and production of packaging, and companies which manufacture inks, coatings, adhesives and packaging machinery. It will be essential reading for students of packaging technology and technologists working in food manufacturing who are users of paper and paperboard packaging products. Praise for the First Edition ‘This book is a valuable addition to the library of any forward-looking company by providing in-depth coverage of all aspects of packaging which involve the most ecologically acceptable material, namely paper and paperboard.’—International Journal of Dairy Technology ‘...a welcome contribution to a field where coverage was previously limited to subject-specific books... or to single chapters in textbooks on broader aspects of packaging technology.’—Packaging Technology and Science

The Better World Handbook

Author : Ellis Jones
ISBN : 9781550923650
Genre : Business & Economics
File Size : 56. 16 MB
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Specifically designed to reach people who normally would not consider themselves activists, The Better World Handbook is directed toward those who care about creating a more just, sustainable, and socially responsible world but don’t know where to begin. Substantially updated, this revised bestseller now contains more recent information on global problems, more effective actions, and many new resources.

The Package Engineering Handbook

Author : Walter Stern
ISBN : UOM:39015023100244
Genre : Packaging
File Size : 88. 53 MB
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Directories In Print

Author :
ISBN : 1414465785
Genre : Business
File Size : 32. 40 MB
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Handbook Of Pharmaceutical Manafacturing Formulations 2nd Ed Sarfaraz K Niazi 2009

Author : Informa Healthcare
ISBN :
Genre : Business & Economics
File Size : 80. 31 MB
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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 [email protected] .com or [email protected] 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

Handbook Of Industrial Inkjet Printing

Author : Werner Zapka
ISBN : 9783527687176
Genre : Technology & Engineering
File Size : 89. 42 MB
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Unique in its integration of individual topics to achieve a full-system approach, this book addresses all the aspects essential for industrial inkjet printing. After an introduction listing the industrial printing techniques available, the text goes on to discuss individual topics, such as ink, printheads and substrates, followed by metrology techniques that are required for reliable systems. Three iteration cycles are then described, including the adaptation of the ink to the printhead, the optimization of the ink to the substrate and the integration of machine manufacturing, monitoring, and data handling, among others. Finally, the book summarizes a number of case studies and success stories from selected areas, including graphics, printed electronics, and 3D printing as well a list of ink suppliers, printhead manufacturers and integrators. Practical hints are included throughout for a direct hands-on experience. Invaluable for industrial users and academics, whether ink developers or mechanical engineers, and working in areas ranging from metrology to intellectual property.

Handbook Of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
ISBN : 9781420081244
Genre : Medical
File Size : 25. 77 MB
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While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Highlights from Liquid Products, Volume Three include: practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing access to what an FDA auditor would be looking for during a liquid manufacturing audit issues that may arise during a US FDA inspection the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines

Handbook Of Lean Manufacturing In The Food Industry

Author : Michael Dudbridge
ISBN : 1444393111
Genre : Technology & Engineering
File Size : 56. 1 MB
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The principles of lean manufacturing – increasing efficiency, reducing waste, lowering costs and improving control – may be applied to any industry. However, the food industry is unique, and creates unique demands. The political, social and economic importance of food is unrivalled by any other form of produce, as is the scrutiny to which the manufacture of food is subjected. For the food industry, lean manufacturing is not simply a cost-saving strategy, but is directly linked to issues of sustainability, the environment, ethics and public accountability. Handbook of Lean Manufacturing in the Food Industry is a major new source of information and ideas for those working in food manufacturing. Offering a fresh and modern perspective on best practice, it points the way to fewer breakdowns, reduced quality faults, improved teamwork and increased profits. With a focus on operations management and new process development, the book is accessible and easy to read, and is complemented by a wealth of practical examples drawn from industry. The author’s conversational style and questioning approach will be invaluable to food manufacturers who are seeking solutions to fundamental issues. The book is directed at those who are working in food manufacturing or the wider food industry, particularly factory operations managers and training teams who are looking for resources to help with lean manufacturing implementations. Others in the supply chain, from producers to retailers, will also find it invaluable. The book is a clear and timely introduction for students and lecturers in food science and technology who want to access the reality of lean manufacturing as well as the theory.

Fish Canning Handbook

Author : Les Bratt
ISBN : 1444390384
Genre : Technology & Engineering
File Size : 49. 48 MB
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Canning continues to be an extremely important form of food preservation commercially, and canned fish represents a source of relatively inexpensive, nutritious and healthy food which is stable at ambient temperatures, has long shelf life and in consequence is eminently suitable for worldwide distribution. It is vitally important that all canning operations are undertaken in keeping with the rigorous application of good manufacturing practices if the food is to be safe at the point of consumption. This demands that all personnel involved in the management and operation of cannery operations have a competent understanding of the technologies involved, including the basic requirements for container integrity and safe heat sterilisation. This book provides a source of up to date and detailed technical information for all those involved in the production of canned fish, from students thinking of entering the industry, to regulatory authorities with responsibility for official inspection, trading companies and retail organisations who purchase canned fish, as well as the manufacturers themselves. An exhaustive range of topics are covered in 15 chapters, including: the current global market; processing, packaging and storage operations; food safety and quality assurance; international legal requirements and laboratory analysis.

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