Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
Author: Byron Lambert
Publisher: Academic Press
Total Pages: 266
Release: 2019-06-15
Genre: Technology & Engineering
ISBN: 0128050829

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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. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
Author: Byron J. Lambert
Publisher: Academic Press
Total Pages: 268
Release: 2019-11-30
Genre: Technology & Engineering
ISBN: 0128131799

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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. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
Author: Tim Sandle
Publisher: Elsevier
Total Pages: 370
Release: 2013-10-31
Genre: Medical
ISBN: 1908818638

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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

Aseptic Processing of Health Care Products. Alternative Processes for Medical Devices and Combination Products

Aseptic Processing of Health Care Products. Alternative Processes for Medical Devices and Combination Products
Author: British Standards Institute Staff
Publisher:
Total Pages: 30
Release: 1913-02-28
Genre:
ISBN: 9780580664458

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Medical equipment, Sterile equipment, Sterilization (hygiene), Production, Clean rooms, Environment (working), Quality assurance systems, Quality management, Quality control, Containers, Verification, Personnel

Quality Assurance of Aseptic Preparation Services

Quality Assurance of Aseptic Preparation Services
Author: Alison M. Beaney
Publisher:
Total Pages: 0
Release: 2016
Genre: Asepsis and antisepsis
ISBN: 9780857113078

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Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.

Sterile Product Development

Sterile Product Development
Author: Parag Kolhe
Publisher: Springer Science & Business Media
Total Pages: 590
Release: 2013-10-12
Genre: Medical
ISBN: 1461479789

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This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

In Situ Tissue Regeneration

In Situ Tissue Regeneration
Author: Sang Jin Lee
Publisher: Academic Press
Total Pages: 460
Release: 2016-07-17
Genre: Medical
ISBN: 012802500X

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In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design explores the body’s ability to mobilize endogenous stem cells to the site of injury and details the latest strategies developed for inducing and supporting the body’s own regenerating capacity. From the perspective of regenerative medicine and tissue engineering, this book describes the mechanism of host cell recruitment, cell sourcing, cellular and molecular roles in cell differentiation, navigational cues and niche signals, and a tissue-specific smart biomaterial system that can be applied to a wide range of therapies. The work is divided into four sections to provide a thorough overview and helpful hints for future discoveries: endogenous cell sources; biochemical and physical cues; smart biomaterial development; and applications. Explores the body’s ability to mobilize endogenous stem cells to the site of injury Details the latest strategies developed for inducing and supporting the body’s own regenerating capacity Presents smart biomaterials in cell-based tissue engineering applications—from the cell level to applications—in the first unified volume Features chapter authors and editors who are authorities in this emerging field Prioritizes a discussion of the future direction of smart biomaterials for in situ tissue regeneration, which will affect an emerging and lucrative industry

Biomaterials, Medical Devices, and Combination Products

Biomaterials, Medical Devices, and Combination Products
Author: Shayne Cox Gad
Publisher: CRC Press
Total Pages: 606
Release: 2015-12-01
Genre: Medical
ISBN: 1482248387

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Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Biomaterials Science

Biomaterials Science
Author: Buddy D. Ratner
Publisher: Academic Press
Total Pages: 1573
Release: 2012-12-31
Genre: Medical
ISBN: 008087780X

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The revised edition of this renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine. Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: "the only such text that currently covers this area comprehensively" - Materials Today Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, case studies and a downloadable image bank

Safety Evaluation in the Development of Medical Devices and Combination Products

Safety Evaluation in the Development of Medical Devices and Combination Products
Author: Shayne C. Gad
Publisher: CRC Press
Total Pages: 314
Release: 2008-10-20
Genre: Medical
ISBN: 1439809488

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Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l