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Author: Ronald Pilchik
Publisher: CRC Press
ISBN: 1040068766
Category : Medical
Languages : en
Pages : 144
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Book Description
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
Author: Ronald Pilchik
Publisher: CRC Press
ISBN: 1040068766
Category : Medical
Languages : en
Pages : 144
Get Book Here
Book Description
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
Author: Ronald Pilchik
Publisher: CRC Press
ISBN: 9781566768078
Category : Technology & Engineering
Languages : en
Pages : 160
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Book Description
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.
Author: Walter Soroka
Publisher: DEStech Publications, Inc
ISBN: 1930268270
Category : Emballage
Languages : en
Pages : 273
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Book Description
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.
Author: Max Sherman
Publisher: CRC Press
ISBN: 9780849384493
Category : Medical
Languages : en
Pages : 422
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Book Description
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.
Author: Carol V. Desain
Publisher: CRC Press
ISBN: 1040204384
Category : Medical
Languages : en
Pages : 340
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Book Description
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies
Author: Wayne A. Taylor
Publisher:
ISBN: 9780963512291
Category :
Languages : en
Pages : 0
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Book Description
Author: Vinny R. Sastri
Publisher: William Andrew
ISBN: 0323851274
Category : Technology & Engineering
Languages : en
Pages : 525
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Book Description
Plastics 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: Robert Packard
Publisher:
ISBN: 9780967311524
Category :
Languages : en
Pages : 258
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Book Description
Reference text on validation processes for manufacturing medical devices.
Author: Kit L. Yam
Publisher: John Wiley & Sons
ISBN: 0470541385
Category : Technology & Engineering
Languages : en
Pages : 1368
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Book Description
The 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: Vinny R. Sastri
Publisher: Elsevier
ISBN: 081552028X
Category : Technology & Engineering
Languages : en
Pages : 289
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Book Description
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.
