Author : Brian Midcalf
Publisher : Pharmaceutical Press
Page : 292 pages
File Size : 38,66 MB
Release : 2004
Category : Clean rooms
ISBN : 9780853695738
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
Page : 240 pages
File Size : 41,5 MB
Release : 2004-05-27
Category : Medical
ISBN : 9781420025842
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 : Jennie Watson
Publisher : Elsevier Health Sciences
Page : 571 pages
File Size : 32,26 MB
Release : 2014-01-16
Category : Medical
ISBN : 0702052825
The fifth edition of Pharmaceutical Practice has been totally overhauled and restructured to bring the contents completely up to date and to reflect emerging new roles for pharmacists both within the traditional employment areas of hospital and community pharmacy, as well as other developing roles supporting the public health agenda, governance, risk management, prescribing and pharmacoeconomics. It 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, cost-benefit, and medicines management. Each chapter begins with Study Point and ends with Key Points to reinforce learning. Appendices include medical abbreviations, Latin terms and abbreviations, systems of weights and measurements, presentation skills and key references. Self-assessment questions for more complex areas of pharmaceutical practice. New chapters on control of medicines; control of health professionals and their staff; ethics in practice; Standard Operating Procedures; structure and organisation of pharmacy; veterinary pharmacy; appliances; public health, and pharmacy interventions. New editor on the team, Jennie Watson. Many new contributors, comprising practising pharmacists, teachers of pharmacy, and pharmacists with joint appointments between hospital/community pharmacy and universities.
Author : Hans-Jürgen Bässler
Publisher : Springer Science & Business Media
Page : 176 pages
File Size : 46,92 MB
Release : 2013-10-01
Category : Science
ISBN : 364239292X
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 : Arthur J. Winfield
Publisher : Elsevier Health Sciences
Page : 663 pages
File Size : 23,50 MB
Release : 2009-07-21
Category : Medical
ISBN : 0702041874
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 : Bill Bennett
Publisher : IChemE
Page : 500 pages
File Size : 41,25 MB
Release : 2003
Category : Medical
ISBN : 9780852954409
This title is a general introduction aimed at all those involved in the engineering stages required for the manufacturr of the active ingredient and its dosage forms.
Author : Tim Sandle
Publisher : Elsevier
Page : 370 pages
File Size : 36,36 MB
Release : 2013-10-31
Category : Medical
ISBN : 1908818638
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 : William Whyte
Publisher : John Wiley & Sons
Page : 382 pages
File Size : 31,66 MB
Release : 2011-08-17
Category : Technology & Engineering
ISBN : 1119965594
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)
Author : James Agalloco
Publisher : CRC Press
Page : 495 pages
File Size : 10,22 MB
Release : 2016-04-19
Category : Medical
ISBN : 1439825440
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 : Roger W. Welker
Publisher : John Wiley & Sons
Page : 600 pages
File Size : 40,40 MB
Release : 2006-08-04
Category : Technology & Engineering
ISBN : 047000777X
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.
