Download or read book Packaging for Terminally Sterilized Medical Devices written by and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: BS EN ISO 11607-2:2020 specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
Download or read book Packaging for Terminally Sterilized Medical Devices Validation Requirements for Forming Sealing and Assembly Processes written by British Standards Institute Staff and published by . This book was released on 1918-05-15 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sealing processes, Packaging, Packaging processes, Acceptance (approval), Sterile equipment, Performance testing, Seals, Verification, Packaging materials, Sterilization (hygiene), Packages, Medical equipment, Medical instruments, Wrapping, Performance, Quality assurance systems, Quality
Download or read book The Wiley Encyclopedia of Packaging Technology written by Kit L. Yam and published by John Wiley & Sons. This book was released on 2010-01-05 with total page 1368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by William Andrew. This book was released on 2021-11-24 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Block s Disinfection Sterilization and Preservation written by Gerald McDonnell and published by Lippincott Williams & Wilkins. This book was released on 2020-06-26 with total page 2941 pages. Available in PDF, EPUB and Kindle. Book excerpt: With more international contributors than ever before, Block’s Disinfection, Sterilization, and Preservation, 6th Edition, is the first new edition in nearly 20 years of the definitive technical manual for anyone involved in physical and chemical disinfection and sterilization methods. The book focuses on disease prevention—rather than eradication—and has been thoroughly updated with new information based on recent advances in the field and understanding of the risks, the technologies available, and the regulatory environments.
Download or read book ISO 13485 2016 written by Itay Abuhav and published by CRC Press. This book was released on 2018-05-11 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Download or read book Handbook of Nonwovens written by S. J. Russell and published by Woodhead Publishing. This book was released on 2022-05-31 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Nonwovens, Second Edition updates and expands its popular interdisciplinary treatment of the properties, processing, and applications of nonwovens. Initial chapters review the development of the industry and the different classes of nonwoven material. The book then discusses methods of manufacture such as dry-laid, wet-laid, and polymer-laid web formation. Other techniques analyzed include mechanical, thermal, and chemical bonding, as well as chemical and mechanical finishing systems. The book concludes by assessing the characterization, testing, and modeling of nonwoven materials.Covering an unmatched range of materials with a variety of compositions and manufacturing routes, this remains the indispensable reference to nonwovens for designers, engineers, materials scientists, and researchers, particularly those interested in the manufacturing of automotive, aerospace, and medical products. Nonwovens are a unique class of textile material formed from fibers that are bonded together through various means to form a coherent structure. The range of properties they can embody make them an important part of a range of innovative products and solutions, which continues to attract interest from industry as well as academia. - Describes in detail the manufacturing processes of a range of nonwoven materials - Provides detailed coverage of the mechanical and thermal properties of non-woven fabrics - Includes extensive updates throughout on the characterization and testing of nonwovens - Explains how to model nonwoven structures
Download or read book Decontamination in Hospitals and Healthcare written by James T. Walker and published by Woodhead Publishing. This book was released on 2014-02-13 with total page 719 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decontamination in Hospitals and Healthcare brings an understanding of decontamination practices and the development of technologies for cleaning and control of infection to a wide audience interested in public health, including healthcare specialists, scientists, students or patients. Part one highlights the importance and history of decontamination in hospitals and healthcare before exploring the role of standards in decontamination, infection control in Europe, and future trends in the area. Part two focuses on decontamination practices in hospitals and healthcare. It considers the role of the nurse in decontamination, the issues of microbial biofilm in waterlines, control of waterborne microorganisms, and the use of gaseous decontamination technologies. Further chapters explore decontamination of prions, the use of protective clothing, no-touch automated room disinfection systems, and controlling the presence of microorganisms in hospitals. Part three discusses practices for decontamination and sterilization of surgical instruments and endoscopes. These chapters examine a range of guidance documents, including the choice framework for local policy and procedures for decontamination of surgical instruments, as well as novel technologies for cleaning and detection of contamination. Decontamination in Hospitals and Healthcare provides a reference source on decontamination for public health professionals and students concerned with healthcare. It is particularly useful for scientists in microbiology and disinfection/decontamination laboratories, healthcare workers who use disinfectants, students in microbiology, clinicians, members of the Institute of Decontamination Sciences/Central Sterilising Club, and those employed in the Central Sterile Services departments of healthcare facilities. - Discusses decontamination processes in Europe - Provides an in-depth understanding into decontamination in healthcare settings, specifically hospitals and dental practices - Examines the decontamination of surgical equipment and endoscopes
Download or read book Assurance of Sterility for Sensitive Combination Products and Materials written by Byron J. Lambert and published by Academic Press. This book was released on 2019-11-30 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design.
Download or read book Medical Device Guidelines and Regulations Handbook written by Prakash Srinivasan Timiri Shanmugam and published by Springer Nature. This book was released on 2022-04-22 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
Download or read book The Effect of Sterilization on Plastics and Elastomers written by Laurence W. McKeen and published by William Andrew. This book was released on 2018-02-22 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Effect of Sterilization Methods on Plastics and Elastomers, Fourth Edition brings together a wide range of essential data on the sterilization of plastics and elastomers, thus enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials and sterilization method for a given product or application. The book is a unique and essential reference for anybody working with plastic materials that are likely to be exposed to sterilization methods, be it in medical device or packaging development, food packaging or other applications. - Presents essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment - Updated edition removes obsolete data, updates manufacturers, verifies data accuracy, and adds new plastics materials for comparison - Provides essential information and guidance for FDA submissions required for new medical devices
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Download or read book Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sterility Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Download or read book Characterisation and Design of Tissue Scaffolds written by Paul Tomlins and published by Elsevier. This book was released on 2015-10-30 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Characterisation and Design of Tissue Scaffolds offers scientists a useful guide on the characterization of tissue scaffolds, detailing what needs to be measured and why, how such measurements can be made, and addressing industrially important issues. Part one provides readers with information on the fundamental considerations in the characterization of tissue scaffolds, while other sections detail how to prepare tissue scaffolds, discuss techniques in characterization, and present practical considerations for manufacturers. - Summarizes concepts and current practice in the characterization and design of tissue scaffolds - Discusses design and preparation of scaffolds - Details how to prepare tissue scaffolds, discusses techniques in characterization, and presents practical considerations for manufacturers
Download or read book Developing an ISO 13485 Certified Quality Management System written by Ilkka Juuso and published by CRC Press. This book was released on 2022-03-20 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects. In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.
