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Author : Brian Midcalf
Publisher : Pharmaceutical Press
Page : 292 pages
File Size : 48,7 Mb
Release : 2004
Category : Clean rooms
ISBN : 0853695733
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 : 48,6 Mb
Release : 2004-05-27
Category : Medical
ISBN : 1420025848
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 : Gerard Lee
Publisher : Stationery Office Books (TSO)
Page : 50 pages
File Size : 46,5 Mb
Release : 1994-01-01
Category : Pharmaceutical industry
ISBN : 0117018295
This second edition has been revised and contains numerous additions. Its objective is to consider the specifications necessary in the design, construction, commissioning and maintenance of isolators, and to present a comprehensive document for use by manufacturers and users. It is sufficiently detailed to form the basis of a standards document that could be adopted by the BSI or CEN committees.
Author : Jennie Watson,Judith A Rees,Ian Smith
Publisher : Elsevier Health Sciences
Page : 571 pages
File Size : 41,5 Mb
Release : 2014-01-16
Category : Medical
ISBN : 9780702052828
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 : Arthur J. Winfield,Judith Rees,Ian Smith
Publisher : Elsevier Health Sciences
Page : 663 pages
File Size : 42,5 Mb
Release : 2009-07-21
Category : Medical
ISBN : 9780702041877
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 : Alison M. Beaney
Publisher : Pharmaceutical Press
Page : 172 pages
File Size : 55,9 Mb
Release : 2006
Category : Asepsis and antisepsis
ISBN : 0853696152
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 : Tim Sandle
Publisher : Elsevier
Page : 370 pages
File Size : 45,9 Mb
Release : 2013-10-31
Category : Medical
ISBN : 9781908818638
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 : James Agalloco,James Akers
Publisher : CRC Press
Page : 495 pages
File Size : 42,8 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781439825440
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 : Adam Fraise,Christina Bradley
Publisher : CRC Press
Page : 523 pages
File Size : 55,5 Mb
Release : 2009-05-29
Category : Business & Economics
ISBN : 9781444115093
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 : Dr. Santosh Karajgi , Dr. Shripad S Potadar , Dr. Sudha Patil , Mr. Ajay Shahapur , Ms. Maharani H Bhandarakavathe
Publisher : Shashwat Publication
Page : 290 pages
File Size : 47,8 Mb
Release : 2024-05-07
Category : Medical
ISBN : 9789360872588
The Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evolution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple-Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
Author : Bill Bennett,Graham Cole
Publisher : IChemE
Page : 500 pages
File Size : 48,6 Mb
Release : 2003
Category : Medical
ISBN : 0852954409
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 : Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman,Brendan F. Gilmore
Publisher : John Wiley & Sons
Page : 534 pages
File Size : 41,9 Mb
Release : 2011-11-22
Category : Medical
ISBN : 9781118293829
Pharmaceutical microbiology has a bearing on all aspects of pharmacy, from the manufacture and quality control of pharmaceutical products through to an understanding of the mode of action of antibiotics. Fully revised and restructured, drawing on the contributions of subject experts, and including material relevant to the European curricula in pharmacy, the eighth edition covers: biology of micro-organisms pathogens and host response prescribing therapeutics contamination and infection control pharmaceutical production current trends and new directions Hugo and Russell’s Pharmaceutical Microbiology, a standard text for Schools of Pharmacy for seven editions, continues to be a user-friendly and authoritative guide for both students and practitioners of pharmacy and pharmaceutical microbiology. 'Highly Commended' in the Pharmacology section of the 2012 BMA Book Awards
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Page : 2756 pages
File Size : 46,5 Mb
Release : 2019-07-19
Category : Business & Economics
ISBN : 9780429574726
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Page : 420 pages
File Size : 51,6 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420086461
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the
Author : Hans-Jürgen Bässler,Frank Lehmann
Publisher : Springer Science & Business Media
Page : 176 pages
File Size : 45,5 Mb
Release : 2013-10-01
Category : Science
ISBN : 9783642392924
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.