Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
Author: Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publsiher: Academic Press
Total Pages: 252
Release: 2019-06-15
ISBN 10: 0128050829
ISBN 13: 9780128050828
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

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

In Situ Tissue Regeneration

In Situ Tissue Regeneration
Author: Sang Jin Lee,Anthony Atala,James J Yoo
Publsiher: Academic Press
Total Pages: 458
Release: 2016-07-17
ISBN 10: 012802500X
ISBN 13: 9780128025000
Language: EN, FR, DE, ES & NL

In Situ Tissue Regeneration Book Review:

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,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

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.

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

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.

USP35 NF30 2012

USP35 NF30  2012
Author: United States Pharmacopeial Convention
Publsiher: U.S. Pharmacopeia
Total Pages: 5089
Release: 2011-11
ISBN 10: 9781936424009
ISBN 13: 1936424002
Language: EN, FR, DE, ES & NL

USP35 NF30 2012 Book Review:

The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).

Parenteral Quality Control

Parenteral Quality Control
Author: Michael K. Akers,Michael K. Larrimore,Dana Guazzo
Publsiher: CRC Press
Total Pages: 401
Release: 2002-11-20
ISBN 10: 0824745663
ISBN 13: 9780824745660
Language: EN, FR, DE, ES & NL

Parenteral Quality Control Book Review:

Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to test

JPMA The Journal of the Pakistan Medical Association

JPMA  The Journal of the Pakistan Medical Association
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1990
ISBN 10: 1928374650XXX
ISBN 13: UCAL:C3071614
Language: EN, FR, DE, ES & NL

JPMA The Journal of the Pakistan Medical Association Book Review:

Bacteriological Analytical Manual

Bacteriological Analytical Manual
Author: United States. Food and Drug Administration. Division of Microbiology
Publsiher: Unknown
Total Pages: 135
Release: 1969
ISBN 10: 1928374650XXX
ISBN 13: STANFORD:36105214583721
Language: EN, FR, DE, ES & NL

Bacteriological Analytical Manual Book Review:

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products
Author: Maria Cristina Galli,Mercedes Serabian
Publsiher: Springer
Total Pages: 230
Release: 2015-09-15
ISBN 10: 3319186183
ISBN 13: 9783319186184
Language: EN, FR, DE, ES & NL

Regulatory Aspects of Gene Therapy and Cell Therapy Products Book Review:

This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.

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: 1928374650XXX
ISBN 13: UOM:39015011064527
Language: EN, FR, DE, ES & NL

Introduction to Sterilization and Disinfection Book Review:

Sterile Services Department

Sterile Services Department
Author: NHS Estates,NHS Estates Staff
Publsiher: The Stationery Office
Total Pages: 88
Release: 2004
ISBN 10: 9780113224920
ISBN 13: 0113224923
Language: EN, FR, DE, ES & NL

Sterile Services Department Book Review:

Provides guidance to help health planners, estates and facilities managers, sterile services managers and capital planning and design teams to plan and design a sterile services department. It discusses the objectives of a sterile services department (SSD) and service requirements, particularly focusing on: raising standards in decontamination services by optimising the built environment: service requirements strategy: calculating the optimum capacity of an SSD to eradicate bottlenecks: determining the most appropriate location of an SSD. Design guidance based on the above service objectives is outlined. Finally, the finer details of the individual spaces within an SSD are discussed.

Laboratory Biosafety Manual

Laboratory Biosafety Manual
Author: World Health Organisation Staff,World Health Organization
Publsiher: World Health Organization
Total Pages: 196
Release: 2004-12-28
ISBN 10: 9789241546508
ISBN 13: 9241546506
Language: EN, FR, DE, ES & NL

Laboratory Biosafety Manual Book Review:

This is the third edition of this manual which contains updated practical guidance on biosafety techniques in laboratories at all levels. It is organised into nine sections and issues covered include: microbiological risk assessment; lab design and facilities; biosecurity concepts; safety equipment; contingency planning; disinfection and sterilisation; the transport of infectious substances; biosafety and the safe use of recombinant DNA technology; chemical, fire and electrical safety aspects; safety organisation and training programmes; and the safety checklist.

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
Author: Mahmoud Aljurf,John A. Snowden,Patrick Hayden,Kim H. Orchard,Eoin McGrath
Publsiher: Springer Nature
Total Pages: 181
Release: 2021-02-19
ISBN 10: 3030644928
ISBN 13: 9783030644925
Language: EN, FR, DE, ES & NL

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Book Review:

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.

Compounding Sterile Preparations

Compounding Sterile Preparations
Author: E. Clyde Buchanan,Phillip J. Schneider
Publsiher: ASHP
Total Pages: 481
Release: 2009-02-01
ISBN 10: 1585283312
ISBN 13: 9781585283316
Language: EN, FR, DE, ES & NL

Compounding Sterile Preparations Book Review:

Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.

Anthrax in Humans and Animals

Anthrax in Humans and Animals
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 208
Release: 2008
ISBN 10: 9241547537
ISBN 13: 9789241547536
Language: EN, FR, DE, ES & NL

Anthrax in Humans and Animals Book Review:

This fourth edition of the anthrax guidelines encompasses a systematic review of the extensive new scientific literature and relevant publications up to end 2007 including all the new information that emerged in the 3-4 years after the anthrax letter events. This updated edition provides information on the disease and its importance, its etiology and ecology, and offers guidance on the detection, diagnostic, epidemiology, disinfection and decontamination, treatment and prophylaxis procedures, as well as control and surveillance processes for anthrax in humans and animals. With two rounds of a rigorous peer-review process, it is a relevant source of information for the management of anthrax in humans and animals.

FDA Investigations Operations Manual

FDA Investigations Operations Manual
Author: United States. Food and Drug Administration
Publsiher: Government Inst
Total Pages: 599
Release: 2003-01
ISBN 10: 9780865879737
ISBN 13: 0865879737
Language: EN, FR, DE, ES & NL

FDA Investigations Operations Manual Book Review:

Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.