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.

"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.

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)

"Fourth Edition features four case histories of production and marketing problems caused by quality and communications gaps, a new perspective on the importance of bar coades, an updated and enlarged chapter on performance testing of unit loads and shipping regulations, new information on advanced flexible packaging, and more."

Presents a comprehensive background on the development of packages and packaging systems for foods, examining the aspects of packaging technology that are relevant to the processing, preservation, distribution, and marketing of a particular food and the areas of food science and technology that influence the packaging process.;This book is designed to be of interest to food scientists and technologists, packaging engineers, designers, and technologists, quality assurance personnel and upper-level undergraduate and graduate students in these disciplines.

Identifies the cost sensitive areas for each activity in the logistical system. Illustrates how packaging in addition to protecting and preserving contents can affect total system cost efficiency if designed to adapt well to unitized shipping methods and equipment: efficiently utilize warehouse stor

Abundant, detailed information on how plastics are used in modern food distribution and the qualitative and quantitative linkages between food requirements and plastics' fabrication and performance. Covers technical properties, fabrication methods, economics, design calculations, regulations, use of

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.

Plastics currently form one of the most important components of the medical industry. Medical device designers and engineers increasingly prefer plastics to conventional packaging materials such as metals owing to superior flexibility offered by plastics in fabrication process. Advancements in sterilization techniques shift towards disposable devices, development of enhanced plastic materials, and technological innovations are factors driving the overall market growth and expansion. The development of novel materials such as biocompatible polymers for use in medical implants will furthermore provide the required impetus for the global medical plastics market. Every day, plastics are involved in critical surgeries, life saving efforts, and routine medical procedures. Plastic materials can be sterilized hundreds of times without degradation. Lightweight plastics are used to form replacement joints, non surgical supports, and therapy equipment. Clear plastics provide visibility for transfusions, surgeries, and diagnostic equipment of all kinds and plastics can be machined, molded, or formed into almost any shape imaginable. The use of plastics in health care field encompasses several distinct markets. Plastic is used on a large scale as medical devices like disposable syringes, optical and dental products, heart valves, contact lenses and many more medical products. This way plastic has very importance in making medical devices. The medical plastics industry is set to expand rapidly over the next decade taking up increasing proportions of GDP, as countries provide healthcare to an ageing population, access to medicine expands in developing regions and new technology is developed. This book basically deals with significance of packaging for pharmaceuticals & medical industry, tablets & capsules liquids, creams and ointments, OPVC, OPP and oriented and non oriented pet containers, blister trays for ampoules, cartridge tubes etc., shrink packaging and stretch wrapping, conducting health based risk assessments of medical materials, performance properties of metallocene polyethylene, EVA, and flexible PVC films, polyurethane thin film welding for medical device applications, polyurethane film as an alternative to PVC and latex, opportunities for PVC replacement in medical solution containers, thermoplastic silicone urethane copolymers : a new class of biomedical elastomers, selecting materials for medical products : from PVC to metallocene polyolefins, injection molding engineering plastics, assessing the performance and suitability of parylene coating etc. The present book contains the important information of plastics in medical field and their uses in various ways. This is very useful book for entrepreneurs, researchers, technocrats and technical institutions. 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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.