Assurance Of Sterility For Sensitive Combination Products And Materials

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Assurance of Sterility for Sensitive Combination Products and Materials

Author : Byron Lambert
Publisher : Academic Press
ISBN 13 : 0128050829
Total Pages : 266 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Assurance of Sterility for Sensitive Combination Products and Materials by : Byron Lambert

Download or read book Assurance of Sterility for Sensitive Combination Products and Materials written by Byron Lambert and published by Academic Press. This book was released on 2019-06-15 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. 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

Author : Byron J. Lambert
Publisher : Academic Press
ISBN 13 : 0128131799
Total Pages : 268 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Assurance of Sterility for Sensitive Combination Products and Materials by : Byron J. Lambert

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 268 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. 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

Guideline on Sterile Drug Products Produced by Aseptic Processing

Author : Center for Drugs and Biologics (U.S.)
Publisher :
ISBN 13 :
Total Pages : 48 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline on Sterile Drug Products Produced by Aseptic Processing by : Center for Drugs and Biologics (U.S.)

Download or read book Guideline on Sterile Drug Products Produced by Aseptic Processing written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1987 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Quality Assurance of Aseptic Preparation Services

Author : Alison M. Beaney
Publisher :
ISBN 13 : 9780857113078
Total Pages : 0 pages
Book Rating : 4.1/5 (13 download)

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Book Synopsis Quality Assurance of Aseptic Preparation Services by : Alison M. Beaney

Download or read book Quality Assurance of Aseptic Preparation Services written by Alison M. Beaney and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Parag Kolhe
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 590 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Sterile Product Development by : Parag Kolhe

Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Sang Jin Lee
Publisher : Academic Press
ISBN 13 : 012802500X
Total Pages : 458 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis In Situ Tissue Regeneration by : Sang Jin Lee

Download or read book In Situ Tissue Regeneration written by Sang Jin Lee and published by Academic Press. This book was released on 2016-07-17 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Shayne Cox Gad
Publisher : CRC Press
ISBN 13 : 1482248387
Total Pages : 606 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Biomaterials, Medical Devices, and Combination Products by : Shayne Cox Gad

Download or read book Biomaterials, Medical Devices, and Combination Products written by Shayne Cox Gad and published by CRC Press. This book was released on 2015-12-01 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Bacteriological Analytical Manual

Author : United States. Food and Drug Administration. Division of Microbiology
Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Bacteriological Analytical Manual by : United States. Food and Drug Administration. Division of Microbiology

Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Biomaterials Science

Author : Buddy D. Ratner
Publisher : Academic Press
ISBN 13 : 008087780X
Total Pages : 1573 pages
Book Rating : 4.0/5 (88 download)

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Book Synopsis Biomaterials Science by : Buddy D. Ratner

Download or read book Biomaterials Science written by Buddy D. Ratner and published by Academic Press. This book was released on 2012-12-31 with total page 1573 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : Shayne C. Gad
Publisher : CRC Press
ISBN 13 : 1439809488
Total Pages : 314 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Safety Evaluation in the Development of Medical Devices and Combination Products by : Shayne C. Gad

Download or read book Safety Evaluation in the Development of Medical Devices and Combination Products written by Shayne C. Gad and published by CRC Press. This book was released on 2008-10-20 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Sterilisation of Biomaterials and Medical Devices

Author : Sophie Lerouge
Publisher : Elsevier
ISBN 13 : 0857096265
Total Pages : 347 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Sterilisation of Biomaterials and Medical Devices by : Sophie Lerouge

Download or read book Sterilisation of Biomaterials and Medical Devices written by Sophie Lerouge and published by Elsevier. This book was released on 2012-09-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

Sterilization Manual for Health Centers

Author : Silvia I. Acosta-Gnass
Publisher : Pan Amer Health Org
ISBN 13 : 9789275129265
Total Pages : 167 pages
Book Rating : 4.1/5 (292 download)

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Book Synopsis Sterilization Manual for Health Centers by : Silvia I. Acosta-Gnass

Download or read book Sterilization Manual for Health Centers written by Silvia I. Acosta-Gnass and published by Pan Amer Health Org. This book was released on 2010 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated sterilisation manual informs health workers about the simple protocols and procedures that have been developed to prevent hospital-acquired infections both inside and outside the sterilisation plant. The guidelines included in this manual show the steps to follow in cleaning, preparing, sterilizing, storing and transporting hospital equipment so as to obtain sterile material. It is very important to be aware of this information in order to provide patients with safe health care.

Modern Methods of Clinical Investigation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Pharmaceutical Microbiology Manual

Author : United States Food and Drug Administration
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781976578670
Total Pages : 92 pages
Book Rating : 4.5/5 (786 download)

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Book Synopsis Pharmaceutical Microbiology Manual by : United States Food and Drug Administration

Download or read book Pharmaceutical Microbiology Manual written by United States Food and Drug Administration and published by Createspace Independent Publishing Platform. This book was released on 2017-09-21 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

Practical Healthcare Epidemiology

Author : Ebbing Lautenbach
Publisher : Cambridge University Press
ISBN 13 : 1107153166
Total Pages : 455 pages
Book Rating : 4.1/5 (71 download)

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Book Synopsis Practical Healthcare Epidemiology by : Ebbing Lautenbach

Download or read book Practical Healthcare Epidemiology written by Ebbing Lautenbach and published by Cambridge University Press. This book was released on 2018-04-19 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, hands-on outline of best practices for infection prevention that directly improve patient outcomes across the healthcare continuum.

FDA Biotechnology Inspection Guide

Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis FDA Biotechnology Inspection Guide by : United States. Food and Drug Administration

Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Peptide Therapeutics

Author : Ved Srivastava
Publisher : Royal Society of Chemistry
ISBN 13 : 1788014332
Total Pages : 572 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Peptide Therapeutics by : Ved Srivastava

Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.