Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
Author: Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
Publsiher: Academic Press
Total Pages: 262
Release: 2019-12-12
ISBN 10: 0128131799
ISBN 13: 9780128131794
Language: EN, FR, DE, ES & NL

Assurance of Sterility for Sensitive Combination Products and Materials Book Review:

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

Biomaterials Medical Devices and Combination Products

Biomaterials  Medical Devices  and Combination Products
Author: Shayne Cox Gad,Samantha Gad-McDonald
Publsiher: CRC Press
Total Pages: 606
Release: 2015-12-01
ISBN 10: 1482248387
ISBN 13: 9781482248388
Language: EN, FR, DE, ES & NL

Biomaterials Medical Devices and Combination Products Book Review:

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,Allan S. Hoffman,Frederick J. Schoen,Jack E. Lemons
Publsiher: Academic Press
Total Pages: 1573
Release: 2012-12-31
ISBN 10: 008087780X
ISBN 13: 9780080877808
Language: EN, FR, DE, ES & NL

Biomaterials Science Book Review:

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 Third Edition

Safety Evaluation in the Development of Medical Devices and Combination Products  Third Edition
Author: Shayne C. Gad,Marian G. McCord
Publsiher: CRC Press
Total Pages: 504
Release: 2008-10-20
ISBN 10: 1439809488
ISBN 13: 9781439809488
Language: EN, FR, DE, ES & NL

Safety Evaluation in the Development of Medical Devices and Combination Products Third Edition Book Review:

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-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
Author: Tim Sandle
Publsiher: Elsevier
Total Pages: 362
Release: 2013-10-31
ISBN 10: 1908818638
ISBN 13: 9781908818638
Language: EN, FR, DE, ES & NL

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Book Review:

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

AAMI Standards and Recommended Practices

AAMI Standards and Recommended Practices
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1992
ISBN 10:
ISBN 13: UOM:39015031258547
Language: EN, FR, DE, ES & NL

AAMI Standards and Recommended Practices Book Review:

Introduction to Sterilization and Disinfection

Introduction to Sterilization and Disinfection
Author: Joan F. Gardner,Margaret M. Peel
Publsiher: Unknown
Total Pages: 183
Release: 1986
ISBN 10:
ISBN 13: UOM:39015011064527
Language: EN, FR, DE, ES & NL

Introduction to Sterilization and Disinfection Book Review:

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
Author: Sophie Lerouge,Anne Simmons
Publsiher: Elsevier
Total Pages: 352
Release: 2012-09-27
ISBN 10: 0857096265
ISBN 13: 9780857096265
Language: EN, FR, DE, ES & NL

Sterilisation of Biomaterials and Medical Devices Book Review:

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

Sterilization Manual for Health Centers
Author: Silvia I. Acosta-Gnass,Valeska De Andrade Stempliuk
Publsiher: Pan Amer Health Org
Total Pages: 167
Release: 2010
ISBN 10: 9789275129265
ISBN 13: 9275129266
Language: EN, FR, DE, ES & NL

Sterilization Manual for Health Centers Book Review:

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.

Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance
Author: Mr. Manohar A. Potdar
Publsiher: Pragati Books Pvt. Ltd.
Total Pages: 420
Release: 2006
ISBN 10: 9788185790596
ISBN 13: 8185790590
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality Assurance Book Review:

Polymers in Medical Applications

Polymers in Medical Applications
Author: B.J. Lambert,F.-W. Tang,W. J. Rogers
Publsiher: iSmithers Rapra Publishing
Total Pages: 146
Release: 2001
ISBN 10: 9781859572597
ISBN 13: 1859572596
Language: EN, FR, DE, ES & NL

Polymers in Medical Applications Book Review:

The use of polymers in medical devices is growing at a steady rate. These materials are generally relatively cheap and versatile, qualities required in many bulk applications. In more specialised medical devices, polymeric components have been developed to meet challenging property and performance requirements. This review describes the process of developing polymeric products for medical applications from design requirements through to specific examples of medical devices and packaging. An additional indexed section containing several hundred abstracts from the Rapra Polymer Library database gives useful references for further reading.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author: Safaraz K. Niazi
Publsiher: CRC Press
Total Pages: 464
Release: 2016-04-19
ISBN 10: 1420081314
ISBN 13: 9781420081312
Language: EN, FR, DE, ES & NL

Handbook of Pharmaceutical Manufacturing Formulations Book Review:

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Manual for Pharmacy Technicians

Manual for Pharmacy Technicians
Author: Bonnie S. Bachenheimer
Publsiher: ASHP
Total Pages: 616
Release: 2010-09-10
ISBN 10: 9781585283071
ISBN 13: 158528307X
Language: EN, FR, DE, ES & NL

Manual for Pharmacy Technicians Book Review:

The trusted training resource for pharmacy technicians at all levels. The role of pharmacy technicians is rapidly expanding, and demand for well-trained technicians has never been higher! Technicians are assuming more responsibilities and are taking on greater leadership roles. Quality training material is increasingly important for new technicians entering the field, and current technicians looking to advance. Look no further than the new 4th edition of the best-selling Manual for Pharmacy Technicians to master the practical skills and gain the foundational knowledge all technicians need to be successful. NEW chapters cover the latest essentials: Specialty Pharmacy Practice Communication and Teamwork Billing and Reimbursement Durable and Nondurable Medical Equipment, Devices, and Supplies NEW features include: Full color design, photos and illustrations enhance learning Rx for Success boxes share tips to help techs excel on the job Technology Topics highlight the latest in automation & technical areas Safety First features provide critical advice for enhancing safety & reducing errors Bolded key terms defined in chapter-level glossaries Streamlined contents divide book into 4 simple parts: introduction to pharmacy practice, foundation knowledge and skills, practice basics, and business applications Expanded self-assessment questions and calculations content Alone or with the new edition of the Pharmacy Technician Certification Review and Practice Exam, the Manual for Pharmacy Technicians, 4th Edition offers pharmacy technicians the most relevant, authoritative, easy-to-use guide in the field. Want more exercises and practice? Look for the NEW Workbook for the Manual for Pharmacy Technicians.

National Standards and Recommended Practices for Sterilization

National Standards and Recommended Practices for Sterilization
Author: Association for the Advancement of Medical Instrumentation
Publsiher: Assn for the Advancement of medical
Total Pages: 343
Release: 1988
ISBN 10:
ISBN 13: UCLA:L0061553038
Language: EN, FR, DE, ES & NL

National Standards and Recommended Practices for Sterilization Book Review:

"Contains the complete text of six AAMI recommended practices, six AAMI American National Standards, and two AAMI standards"--p. vii.

JPMA The Journal of the Pakistan Medical Association

JPMA  The Journal of the Pakistan Medical Association
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1990
ISBN 10:
ISBN 13: UCAL:C3071614
Language: EN, FR, DE, ES & NL

JPMA The Journal of the Pakistan Medical Association Book Review:

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
ISBN 10: 0470259809
ISBN 13: 9780470259801
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Pharmaceutical Microbiology Manual

Pharmaceutical Microbiology Manual
Author: United States Food and Drug Administration
Publsiher: Createspace Independent Publishing Platform
Total Pages: 92
Release: 2017-09-21
ISBN 10: 9781976578670
ISBN 13: 1976578671
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Manual Book Review:

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.

Understanding Anesthesia Equipment

Understanding Anesthesia Equipment
Author: Jerry A. Dorsch,Susan E. Dorsch
Publsiher: Unknown
Total Pages: 458
Release: 1984
ISBN 10:
ISBN 13: UOM:39015006703717
Language: EN, FR, DE, ES & NL

Understanding Anesthesia Equipment Book Review:

Who Global Report on Traditional and Complementary Medicine 2019

Who Global Report on Traditional and Complementary Medicine 2019
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 226
Release: 2019-05-16
ISBN 10: 9241515430
ISBN 13: 9789241515436
Language: EN, FR, DE, ES & NL

Who Global Report on Traditional and Complementary Medicine 2019 Book Review:

This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and, finally, the country profiles. Apart from the section on practices and practitioners, the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners, which covers providers, education and health insurance, is a new section incorporated to reflect the emerging trends in T&CM and to gather new information regarding these topics at a national level. All new information received has been incorporated into individual country profiles and data graphs. The report captures the three phases of progress made by Member States; that is, before and after the first WHO Traditional Medicine Strategy (1999-2005), from the first global survey to the second global survey (2005-2012) and from the second survey to the most recent timeline (2012-2018).

Biomedical Engineering and Design Handbook Volume 2

Biomedical Engineering and Design Handbook  Volume 2
Author: Myer Kutz
Publsiher: McGraw Hill Professional
Total Pages: 816
Release: 2009-07-13
ISBN 10: 0071704744
ISBN 13: 9780071704748
Language: EN, FR, DE, ES & NL

Biomedical Engineering and Design Handbook Volume 2 Book Review:

A State-of-the-Art Guide to Biomedical Engineering and Design Fundamentals and Applications The two-volume Biomedical Engineering and Design Handbook, Second Edition, offers unsurpassed coverage of the entire biomedical engineering field, including fundamental concepts, design and development processes, and applications. This landmark work contains contributions on a wide range of topics from nearly 80 leading experts at universities, medical centers, and commercial and law firms. Volume 2 provides timely information on breakthrough developments in medical device design, diagnostic equipment design, surgery, rehabilitation engineering, prosthetics design, and clinical engineering. Filled with more than 400 detailed illustrations, this definitive volume examines cutting-edge design and development methods for innovative devices, techniques, and treatments. Volume 2 covers: Medical Product Design FDA Medical Device Requirements Cardiovascular Devices Design of Respiratory Devices Design of Artificial Kidneys Design of Controlled-Release Drug Delivery Systems Sterile Medical Device Package Development Design of Magnetic Resonance Systems Instrumentation Design for Ultrasonic Imaging The Principles of X-Ray Computed Tomography Nuclear Medicine Imaging Instrumentation Breast Imaging Systems Surgical Simulation Technologies Computer-Integrated Surgery and Medical Robotics Technology and Disabilities Applied Universal Design Design of Artificial Arms and Hands for Prosthetic Applications Design of Artificial Limbs for Lower Extremity Amputees Wear of Total Knee and Hip Joint Replacements Home Modification Design Intelligent Assistive Technology Rehabilitators Risk Management in Healthcare Technology Planning for Healthcare Institutions Healthcare Facilities Planning Healthcare Systems Engineering Enclosed Habitat Life Support