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Assurance Of Sterility For Sensitive Combination Products And Materials

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Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials Book
Author : Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
Publisher : Academic Press
Release : 2019-12-12
ISBN : 0128131799
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Sang Jin Lee,Anthony Atala,James J Yoo
Publisher : Academic Press
Release : 2016-07-17
ISBN : 012802500X
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Release : 2015-12-01
ISBN : 1482248387
Language : En, Es, Fr & De

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Book Description :

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

Bacteriological Analytical Manual Book
Author : United States. Food and Drug Administration. Division of Microbiology
Publisher : Unknown
Release : 1969
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Bacteriological Analytical Manual book written by United States. Food and Drug Administration. Division of Microbiology, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

ANSI AAMI St79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

ANSI AAMI St79  Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities Book
Author : Aami
Publisher : Association for the Advancement of Medical Instrumentation (AAMI)
Release : 2013-10-01
ISBN : 9780010671384
Language : En, Es, Fr & De

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Book Description :

The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization.

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices Book
Author : Sophie Lerouge,Anne Simmons
Publisher : Elsevier
Release : 2012-09-27
ISBN : 0857096265
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Silvia I. Acosta-Gnass,Valeska De Andrade Stempliuk
Publisher : Pan Amer Health Org
Release : 2010
ISBN : 9789275129265
Language : En, Es, Fr & De

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Book Description :

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 Microbiology Manual

Pharmaceutical Microbiology Manual Book
Author : United States Food and Drug Administration
Publisher : Createspace Independent Publishing Platform
Release : 2017-09-21
ISBN : 9781976578670
Language : En, Es, Fr & De

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Book Description :

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.

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Book
Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Release : 2003-09-02
ISBN : 9780203305195
Language : En, Es, Fr & De

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Book Description :

Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Infection Control and Management of Hazardous Materials for the Dental Team E Book

Infection Control and Management of Hazardous Materials for the Dental Team E Book Book
Author : Chris H. Miller,Charles John Palenik
Publisher : Elsevier Health Sciences
Release : 2014-03-18
ISBN : 0323291406
Language : En, Es, Fr & De

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Book Description :

Maintain safety and infection control in the dental office with Infection Control and Management of Hazardous Materials for the Dental Team, Fourth Edition. This practical and comprehensive resource covers the basic concepts of infectious disease and infection control, including step-by-step descriptions of specific procedures and supplies and equipment needed for disease prevention. The Fourth Edition features new chapters on the latest topics impacting office safety and the most current regulatory recommendations for protection of dental patients and dental workers. No matter what your role on the dental team, this text will help you implement infection control in everyday practice. Follows dental curricula requirements for infection control Subject matter is organized logically, making it easier to successfully comprehend the material. Tables are used throughout the text to highlight similarities and differences among related topics; boxes draw your attention to the information you need to remember most. Line drawings and photos show the latest equipment, supplies, and procedures. Selected readings at the end of each chapter provide sources of further information on the topics discussed. The Glossary defines all key terms in one convenient place. The Resource List includes organizations, federal agencies, and website addresses to help you stay current on rapidly changing topics. An account of the first reported patient-to-patient spread of the hepatitis B virus in a dental office A detailed description of the three types of steam sterilizers including the newest type B office model vacuum sterilizer Information on the wipe-discard-wipe approach to surface disinfection NEW chapter on the Occupational Safety and Health Administration (OSHA) helps you understand OSHA standards and know how to respond in the event of an inspection. Two new tables on office safety management: Measure the Effectiveness of an Infection Control Program and Examples of What to Evaluate in a Dental Office Infection Control Evaluation Program NEW chapter on medical tourism looks at the practice of traveling internationally to obtain health care NEW chapter on greener infection control addresses the impact that infection control procedures can have on the environment and provides suggestions for developing a more eco-friendly program. Addition of Guidelines for Preventing the Transmission of Mycobacterium tuberculosis In Health-Care Settings, 2005, Dental-Care Settings Excerpt A new accompanying EVOLVE site provides a variety of learning resources, including answers for the Review Questions found at the end of each chapter and a printable version of the Exposure Incident Report.

Parenteral Quality Control

Parenteral Quality Control Book
Author : Michael K. Akers,Michael K. Larrimore,Dana Guazzo
Publisher : CRC Press
Release : 2002-11-20
ISBN : 0824745663
Language : En, Es, Fr & De

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Book Description :

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

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products Book
Author : Maria Cristina Galli,Mercedes Serabian
Publisher : Springer
Release : 2015-09-15
ISBN : 3319186183
Language : En, Es, Fr & De

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Book Description :

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.

Compounding Sterile Preparations

Compounding Sterile Preparations Book
Author : E. Clyde Buchanan,Phillip J. Schneider
Publisher : ASHP
Release : 2009-02-01
ISBN : 1585283312
Language : En, Es, Fr & De

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Book Description :

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.

Sterile Services Department

Sterile Services Department Book
Author : NHS Estates,NHS Estates Staff
Publisher : The Stationery Office
Release : 2004
ISBN : 9780113224920
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : World Health Organisation Staff,World Health Organization
Publisher : World Health Organization
Release : 2004-12-28
ISBN : 9789241546508
Language : En, Es, Fr & De

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Book Description :

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.

USP35 NF30 2012

USP35 NF30  2012 Book
Author : United States Pharmacopeial Convention
Publisher : U.S. Pharmacopeia
Release : 2011-11
ISBN : 9781936424009
Language : En, Es, Fr & De

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Book Description :

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).

Sterile Drug Products

Sterile Drug Products Book
Author : Michael J. Akers
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420020560
Language : En, Es, Fr & De

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Book Description :

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

JPMA The Journal of the Pakistan Medical Association

JPMA  The Journal of the Pakistan Medical Association Book
Author : Anonim
Publisher : Unknown
Release : 1990
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download JPMA The Journal of the Pakistan Medical Association book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Book
Author : Mahmoud Aljurf,John A. Snowden,Patrick Hayden,Kim H. Orchard,Eoin McGrath
Publisher : Springer Nature
Release : 2021-02-19
ISBN : 3030644928
Language : En, Es, Fr & De

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Book Description :

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.

Thermal Processing of Food

Thermal Processing of Food Book
Author : Senate Commission on Food Safety SKLM
Publisher : John Wiley & Sons
Release : 2007-09-24
ISBN : 3527611509
Language : En, Es, Fr & De

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Book Description :

This is the latest and most authoritative documentation of current scientific knowledge regarding the health effects of thermal food processing. Authors from all over Europe and the USA provide an international perspective, weighing up the risks and benefits. In addition, the contributors outline those areas where further research is necessary.