Download or read book Pharmaceutical Packaging Handbook written by Edward Bauer and published by CRC Press. This book was released on 2009-03-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices. Supplying a thorough examination of the industry in size and scope, the book covers drug dosage forms, vaccines, biologically produced products, and medical foods. Features: Discusses how packaging is designed and integrated into the product development cycle Provides an overview of the regulatory environment procedures Describes the materials used to package pharmaceuticals, including glass, metal, plastics, flexible films, rubber, and elastomers Examines new hybrids used for packaging Explores the processing techniques used with the materials to produce pharmaceutical containers Discusses some of the strengths and weaknesses of the processes used for container fabrication Explains retort, aseptic, gas, and radiation sterilization of product Reviews labeling and design for pharmaceuticals, including how labels are produced, materials used, and production techniques Complete and straightforward, the book lists information in an easy to follow fashion, making it a complete standalone reference for anyone working in the pharmaceutical industry.
Download or read book Packaging of Pharmaceuticals and Healthcare Products written by Frank A. Paine and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: As was the case with Charles Ross's Packaging of Pharmaceuticals published by the UK Institute of Packaging in 1975 it is assumed that the reader of this book already has a broad understanding of the basics of packaging. If not the Packaging Users Handbook and the Handbook of Food Packaging are recommended. The packaging needs of pharmaceuticals are different in degree only from those of other perishable products such as processed foods. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods for example. Functional efficiency is therefore of prime importance. Conversely the need for the packaging to 'sell' the medication is much less, hence the graphics required need only provide the right 'image' for the product when presented for use in hospital or surgery. Even when on sale at the pharmacy the 'appeal' required is that of providing hygiene and confidence more than anything else. Thus, the textual requirements are paramount including traceability (batch numbers, date-coding etc) in case of recall; while striking appearance to attract customer attention is in lower key. And with the increase in malicious tampering nowadays recall is more frequent.
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Download or read book Pharmaceutical Packaging Technology written by D. A. Dean and published by CRC Press. This book was released on 2005-07-12 with total page 459 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.
Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Download or read book Medical Device Packaging Handbook Revised and Expanded written by Max Sherman and published by CRC Press. This book was released on 1998-08-25 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclave sytems, international standards, customer needs, regulatory aspects, and more.
Download or read book Plastic Packaging written by Otto G. Piringer and published by John Wiley & Sons. This book was released on 2008-06-25 with total page 632 pages. Available in PDF, EPUB and Kindle. Book excerpt: Plastics are the most important class of packaging materials. This successful handbook, now in its second edition, covers all important aspects of plastic packaging and the interdisciplinary knowledge needed by food chemists, pharmaceutical chemists, food technologists, materials scientists, process engineers, and product developers alike. This is an indispensable resource in the search for the optimal plastic packaging. Materials characteristics, additives and their effects, mass transport phenomena, quality assurance, and recent regulatory requirements from FDA and European Commission are covered in detail with ample data.
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Download or read book Handbook of Validation in Pharmaceutical Processes Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Download or read book Illustrated Glossary of Packaging Terminology written by Walter Soroka and published by DEStech Publications, Inc. This book was released on 2008 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprising over 4,500 definitions, this book provides explanation of the often arcane, English-language terminology that denotes the materials and manufacturing processes used in different phases of the packaging industry. It is suitable for those who use packaging technology.
Download or read book Compliance Handbook for Pharmaceuticals Medical Devices and Biologics written by Carmen Medina and published by CRC Press. This book was released on 2003-12-09 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
Download or read book Handbook of Package Engineering written by Joseph F. Hanlon and published by McGraw-Hill Companies. This book was released on 1984 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Magnesium Stearate Handbook written by Patrick C. Okoye and published by iUniverse. This book was released on 2016-11-18 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: Magnesium stearate (MgSt) is widely used in cosmetic, food, and pharmaceutical formulations as lubricant in capsule and tablet manufacture at concentrations between 0.25% and 5%. A recent review of the top two hundred prescription drugs showed over 50% contained magnesium stearate. This book covered a broad spectrum of concentration from 1% to 10% for the purpose of presenting their unique properties during powder rheology, tableting, and effect on drug dissolution. MgSt also has both scientifi c and economic signifi cance, given its wide application in global pharmaceutical manufacturing. An understanding of polymorphism (or pseudopolymorphism) in magnesium stearate and the impact on tablet lubrication process and drug dissolution would provide a valuable tool to pharmaceutical scientists during excipient selection process for new product development and even during reformulation of existing products. Preformulation scientists spend a great deal of time reviewing excipients for new product development both in silico and on the bench. As a result, accurate selection of excipients, such as lubricants, could avoid potential issues with clinical batches, product scale-up, and product transfer during commercialization.
Download or read book Validating Medical Packaging written by Ronald Pilchik and published by CRC Press. This book was released on 2002-09-27 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2004-04-27 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
