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Author: Ronald Pilchik
Publisher: CRC Press
Published: 2002-09-27
Total Pages: 158
ISBN-13: 1420014943
DOWNLOAD EBOOKAccording 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
Author: Ronald Pilchik
Publisher: CRC Press
Published: 2002-09-27
Total Pages: 144
ISBN-13: 1040068766
DOWNLOAD EBOOKAccording 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
Author: Walter Soroka
Publisher: DEStech Publications, Inc
Published: 2008
Total Pages: 273
ISBN-13: 1930268270
DOWNLOAD EBOOKComprising 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.
Author: Max Sherman
Publisher: CRC Press
Published: 1998-08-25
Total Pages: 422
ISBN-13: 9780849384493
DOWNLOAD EBOOKThis 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.
Author: Edward Bauer
Publisher: CRC Press
Published: 2009-03-24
Total Pages: 608
ISBN-13: 9781587161513
DOWNLOAD EBOOKPharmaceutical 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.
Author: Vinny R. Sastri
Publisher: William Andrew
Published: 2021-11-24
Total Pages: 525
ISBN-13: 0323851274
DOWNLOAD EBOOKPlastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. - Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data - Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management - Supports the development, marketing and commercialization of medical devices and materials for use in medical devices
Author: Kit L. Yam
Publisher: John Wiley & Sons
Published: 2010-01-05
Total Pages: 1368
ISBN-13: 0470541385
DOWNLOAD EBOOKThe complete and authoritative guide to modern packaging technologies —updated and expanded From A to Z, The Wiley Encyclopedia of Packaging Technology, Third Edition covers all aspects of packaging technologies essential to the food and pharmaceutical industries, among others. This edition has been thoroughly updated and expanded to include important innovations and changes in materials, processes, and technologies that have occurred over the past decade. It is an invaluable resource for packaging technologists, scientists and engineers, students and educators, packaging material suppliers, packaging converters, packaging machinery manufacturers, processors, retailers, and regulatory agencies. In addition to updating and improving articles from the previous edition, new articles are also added to cover the recent advances and developments in packaging. Content new to this edition includes: Advanced packaging materials such as antimicrobial materials, biobased materials, nanocomposite materials, ceramic-coated films, and perforated films Advanced packaging technologies such as active and intelligent packaging, radio frequency identification (RFID), controlled release packaging, smart blending, nanotechnology, biosensor technology, and package integrity inspection Various aspects important to packaging such as sustainable packaging, migration, lipid oxidation, light protection, and intellectual property Contributions from experts in all-important aspects of packaging Extensive cross-referencing and easy-to-access information on all subjects Large, double-column format for easy reference
Author: James P. Agalloco
Publisher: CRC Press
Published: 2007-09-25
Total Pages: 762
ISBN-13: 1420019791
DOWNLOAD EBOOKCompletely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author: James Agalloco
Publisher: CRC Press
Published: 2021-10-28
Total Pages: 1062
ISBN-13: 1000436012
DOWNLOAD EBOOKRevised 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
Author: Wayne A. Taylor
Publisher:
Published: 2017
Total Pages: 0
ISBN-13: 9780963512291
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