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 Medical Device Packaging Handbook written by Joseph D. O'Brien and published by . This book was released on 1990 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to help manufacturers, engineers, designers, and suppliers of medical products evaluate the design, materials, and technology of their packaging. Highlights recent developments in the field, and presents information on current industry standards and practices, and regulation. Provides details of materials and specifications, sterilization methods, distribution test cycles, labeling criteria, bar coding, autoclave systems, and other topics. Annotation(c) 2003 Book News, Inc., Portland, OR (booknews.com)

Download or read book Medical Device Packaging Handbook Second Edition Revised and Expanded written by Max Sherman and published by . This book was released on 1998 with total page 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."--Provided by publisher.

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 Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Download or read book Microelectronics Packaging Handbook written by R.R. Tummala and published by Springer Science & Business Media. This book was released on 2013-11-27 with total page 1060 pages. Available in PDF, EPUB and Kindle. Book excerpt: Electronics has become the largest industry, surpassing agriculture, auto, and heavy metal industries. It has become the industry of choice for a country to prosper, already having given rise to the phenomenal prosperity of Japan, Korea, Singapore, Hong Kong, and Ireland among others. At the current growth rate, total worldwide semiconductor sales will reach $300B by the year 2000. The key electronic technologies responsible for the growth of the industry include semiconductors, the packaging of semiconductors for systems use in auto, telecom, computer, consumer, aerospace, and medical industries, displays, magnetic, and optical storage as well as software and system technologies. There has been a paradigm shift, however, in these technologies, from mainframe and supercomputer applications at any cost, to consumer applications at approximately one-tenth the cost and size. Personal computers are a good example, going from $500IMIP when products were first introduced in 1981, to a projected $IIMIP within 10 years. Thin, light portable, user friendly and very low-cost are, therefore, the attributes of tomorrow's computing and communications systems. Electronic packaging is defined as interconnection, powering, cool ing, and protecting semiconductor chips for reliable systems. It is a key enabling technology achieving the requirements for reducing the size and cost at the system and product level.

Download or read book The Medical Device Validation Handbook written by Robert Packard and published by . This book was released on 2015-04-05 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference text on validation processes for manufacturing medical devices.

Download or read book UHMWPE Biomaterials Handbook written by Steven M. Kurtz and published by Academic Press. This book was released on 2009-04-27 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: UHMWPE Biomaterials Handbook describes the science, development, properties and application of of ultra-high molecular weight polyethylene (UHMWPE) used in artificial joints. This material is currently used in 1.4 million patients around the world every year for use in the hip, knee, upper extremities, and spine. Since the publication of the 1st edition there have been major advances in the development and clinical adoption of highly crosslinked UHMWPE for hip and knee replacement. There has also been a major international effort to introduce Vitamin E stabilized UHMWPE for patients. The accumulated knowledge on these two classes of materials are a key feature of the 2nd edition, along with an additional 19 additional chapters providing coverage of the key engineering aspects (biomechanical and materials science) and clinical/biological performance of UHMWPE, providing a more complete reference for industrial and academic materials specialists, and for surgeons and clinicians who require an understanding of the biomaterials properties of UHMWPE to work successfully on patient applications. The UHMWPE Handbook is the comprehensive reference for professionals, researchers, and clinicians working with biomaterials technologies for joint replacement New to this edition: 19 new chapters keep readers up to date with this fast moving topic, including a new section on UHMWPE biomaterials; highly crosslinked UHMWPE for hip and knee replacement; Vitamin E stabilized UHMWPE for patients; clinical performance, tribology an biologic interaction of UHMWPE State-of-the-art coverage of UHMWPE technology, orthopedic applications, biomaterial characterisation and engineering aspects from recognised leaders in the field

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 160 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 instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Download or read book Statistical Procedures for the Medical Device Industry written by Wayne A. Taylor and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Polymer Applications in Medicine and Medical Devices written by Vinny R. Sastri and published by Elsevier Inc. Chapters. This book was released on 2013-12-05 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past 2000 years, many devices have been developed and used in the mitigation and diagnosis of diseases. The materials used in these devices have ranged from stone, wood, metal, ceramics, and most recently plastics. Medical devices have also evolved in sophistication and complexity over time. With the formalization of the scientific method in the seventeenth century such devices became more prevalent [1]. Many medical devices were manufactured by doctors or small companies and sold directly to the public with no government standards or oversight. With the explosion of medical technology in the early twentieth century, several intermediaries had evolved between the medical device industry and the public. In 1879, Dr E.R. Squibb, in an address to the Medical Society of the State of New York, proposed the enactment of a national statute to regulate food and drugs [2]. It was not until 27 years later that the Food and Drug Act of 1906 was introduced into the Congress and signed into law by President Theodore Roosevelt [3]. At that time, devices that were harmful to human safety and health proliferated the market but regulation of medical devices by the Bureau of Chemistry (the precursor to the Food and Drug Administration—FDA) was limited to challenging commercial products only after they had been released into the market. Devices in the marketplace that were defective, adulterated, or misbranded were seized and the device manufacturers were prosecuted in a court of law, but only after the products were sold in the market and caused harm to the end users. Thus, there was a strong need for regulating the devices before they entered the marketplace. An FDA report [4], issued in September 1970, detailed as many as 10,000 injuries and 731 deaths from ineffective medical devices. The report recommended the formation of a regulatory system and body that would enforce the production and sale of safe and effective devices to the public. All medical devices already on the market would be inventoried and classified into a three-tiered system based on their criticality of end use. It also detailed requirements for records and reports, registration and inspection of establishments, and uniform quality assurance programs called good manufacturing practices (GMP). After much lobbying by the FDA, Senate bill SR 510, “The Medical Device Amendments of 1973” was introduced by Senator Edward M. Kennedy and was passed by the Senate in 1975. House bill HR 11124, introduced by Representative Paul Rogers, was passed by the House in 1976. These bills eventually became the Medical Device Amendments of 1976, and were signed into law by President Nixon. The Medical Device Amendments of 1976 became the basis for the medical device regulation in the United States to control and regulate the production of finished devices and thus the device manufacturers themselves.

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 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 Handbook of Biopolymers and Biodegradable Plastics written by Sina Ebnesajjad and published by William Andrew. This book was released on 2012-12-31 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopolymers and Biodegradable Plastics are a hot issue across the Plastics industry, and for many of the industry sectors that use plastic, from packaging to medical devices and from the construction indusry to the automotive sector. This book brings together a number of key biopolymer and biodegradable plastics topics in one place for a broad audience of engineers and scientists, especially those designing with biopolymers and biodegradable plastics, or evaluating the options for switching from traditional plastics to biopolymers. Topics covered include preparation, fabrication, applications and recycling (including biodegradability and compostability). Applications in key areas such as films, coatings controlled release and tissue engineering are discussed. Dr Ebnesajjad provides readers with an in-depth reference for the plastics industry – material suppliers and processors, bio-polymer producers, bio-polymer processors and fabricators – and for industry sectors utilizing biopolymers – automotive, packaging, construction, wind turbine manufacturers, film manufacturers, adhesive and coating industries, medical device manufacturers, biomedical engineers, and the recycling industry. Essential information and practical guidance for engineers and scientists working with bioplastics, or evaluating a migration to bioplastics. Includes key published material on biopolymers, updated specifically for this Handbook, and new material including coverage of PLA and Tissue Engineering Scaffolds. Coverage of materials and applications together in one handbook enables engineers and scientists to make informed design decisions.