Author: Brian Midcalf Publisher: Pharmaceutical Press ISBN: 9780853695738 Category : Medical Languages : en Pages : 292
Book Description
This work considers the basic concepts, definitions, and standards necessary in the design, construction, commissioning, maintenance, and use of pharmaceutical isolators.
Author: Tim Coles Publisher: CRC Press ISBN: 9781420025842 Category : Medical Languages : en Pages : 240
Book Description
The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: " Descriptions of and comments on new guidelines and standards " Technological advances - such as the new breed of sanitizing gas generators " Updates that reflect current thinking and new information Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.
Author: James Agalloco Publisher: CRC Press ISBN: 1439825440 Category : Medical Languages : en Pages : 495
Book Description
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies
Author: Hans-Jürgen Bässler Publisher: Springer Science & Business Media ISBN: 364239292X Category : Science Languages : en Pages : 176
Book Description
This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.
Author: Alison M. Beaney Publisher: Pharmaceutical Press ISBN: 9780853696155 Category : Medical Languages : en Pages : 172
Book Description
A detailed guide to the operation and quality assurance of UK hospital aseptic preparation services This new edition of Quality Assurance of Aseptic Preparation Services provides information and up to date national guidance on unlicensed aseptic preparation. Although it is primarily intended for the use of non-licensed UK hospital pharmacies, it will also be of use in licensed units and other countries and institutions. Aseptic services include the preparation of parenteral nutrition solutions (PN), cytotoxics, radiopharmaceuticals, additives for parenteral administration and intrathecals Since the publication of the Breckenridge report in 1976, which recommended that drug additions to intravenous (IV) infusions should be made in hospital pharmacy departments and not on wards, there has been a substantial increase in hospital pharmacy departments providing aseptic preparation services
Author: Adam Fraise Publisher: CRC Press ISBN: 144411509X Category : Business & Economics Languages : en Pages : 523
Book Description
The fifth edition of this classic text is the definitive, clinically orientated guide to a critical area within healthcare practice, full of sound, practical advice for all those involved in the control of infection in a variety of settings. Known in previous editions as Control of Hospital Infection, the new Ayliffe's Control of Healthcare-Associated Infection has again been brought up to date and thoroughly revised to emphasise the broader range of its coverage, from the hospital setting - including the ward, operating theatres, kitchens and laundry facilities - to health care provision in the community.
Author: Arthur J. Winfield Publisher: Elsevier Health Sciences ISBN: 0702041874 Category : Medical Languages : en Pages : 663
Book Description
This comprehensive book covers a wide range of subjects relevant to pharmacy practice, including communication skills, managing a business, quality assurance, dispensing, calculations, packaging, storage and labeling of medicines, sterilization, prescriptions, hospital-based services, techniques and treatments, adverse drug reactions, pharmacoeconomics, and medicines management. Features useful appendices on medical abbreviations, pharmaceutical Latin terms, weights and measures, and presentation skills. This is a core text for pharmacy practice and dispensing modules of the pharmacy curriculum Covers key exam material for essential review and test preparation Features a user-friendly design with clear headings, chapter summaries, helpful boxes, and key points Text restructured with 14 new or radically revised chapters. All text revised in light of current pharmaceutical practice. New design using two colours.
Author: Tim Sandle Publisher: Elsevier ISBN: 1908818638 Category : Medical Languages : en Pages : 370
Book Description
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
Author: Roger W. Welker Publisher: John Wiley & Sons ISBN: 047000777X Category : Technology & Engineering Languages : en Pages : 600
Book Description
A practical "how to" guide that effectively deals with the control of both contamination and ESD This book offers effective strategies and techniques for contamination and electrostatic discharge (ESD) control that can be implemented in a wide range of high-technology industries, including semiconductor, disk drive, aerospace, pharmaceutical, medical device, automobile, and food production manufacturing. The authors set forth a new and innovative methodology that can manage both contamination and ESD, often considered to be mutually exclusive challenges requiring distinct strategies. Beginning with two general chapters on the fundamentals of contamination and ESD control, the book presents a logical progression of topics that collectively build the necessary skills and knowledge: Analysis methods for solving contamination and ESD problems Building the contamination and ESD control environment, including design and construction of cleanrooms and ESD protected environments Cleaning processes and the equipment needed to support these processes Tooling design and certification Continuous monitoring Consumable supplies and packaging materials Controlling contamination and ESD originating from people Management of cleanrooms and ESD protected workplace environments Contamination and ESD Control in High-Technology Manufacturing conveys a practical, working knowledge of contamination and ESD control strategies and techniques, and it is filled with case studies that illustrate key principles and the benefits of contamination and ESD control. Moreover, its straightforward style makes the material, which integrates many disciplines of engineering and science, clear and accessible. Written by three leading industry experts, this book is an essential guide for engineers and designers across the many industries where contamination and ESD control is a concern.
Author: William Whyte Publisher: John Wiley & Sons ISBN: 1119965594 Category : Technology & Engineering Languages : en Pages : 382
Book Description
A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination... This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme. Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries. William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology. A comment on the first edition: "...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)
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Author: Brian Midcalf
Author: Tim Coles
Author: James Agalloco
Author: Hans-Jürgen Bässler
Author: Alison M. Beaney
Author: Adam Fraise
Author: Arthur J. Winfield
Author: Tim Sandle
Author: Roger W. Welker
Author: William Whyte