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Author: Brian Midcalf Publisher: Pharmaceutical Press ISBN: 9780853695738 Category : Clean rooms 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: Brian Midcalf Publisher: Pharmaceutical Press ISBN: 9780853695738 Category : Clean rooms 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: Gerard Lee Publisher: Stationery Office Books (TSO) ISBN: 9780117018297 Category : Pharmaceutical industry Languages : en Pages : 50
Book Description
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: 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: James Agalloco Publisher: CRC Press ISBN: 1000436012 Category : Medical Languages : en Pages : 1062
Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
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: Michael Allwood Publisher: Radcliffe Publishing ISBN: 9781857755046 Category : Antimitotic agents Languages : en Pages : 506
Book Description
Outlines the commitment of various government agencies to biotechnology industries in Australia. Includes statements from AusIndustry, Biotechnology Australia, Invest Australia.
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: John S. Low Publisher: Elsevier Health Sciences ISBN: 0729579166 Category : Medical Languages : en Pages : 241
Book Description
Australian Pharmacy Law & Practice addresses the current issues surrounding pharmacy law and regulation in Australia. As the Federal Government moves to implement a national registration and accreditation scheme for pharmacists, the pharmacy workforce is set to become more mobile as a result. There has been no greater time than now for practising pharmacists and students to understand the implications of current legislation and legal provisions underpinning their area of practice. This text provides a comprehensive analysis and discussion of the legislation and practice standards which are relevant to the practice of pharmacy. As well as covering specific pieces of legislation relating to the regulation of pharmacy practice and drug control, Australian Pharmacy Law & Practice includes important sections on legal concepts and the Australian constitution; the evolution of pharmacy practice and ethics; privacy legislation; occupational health and safety; and professional conduct including matters regarding investigation, discipline, and legal proceedings. Australian Pharmacy Law & Practice is the first text of its kind to address pharmacy practice in all its facets in the unique context of the Australian legal framework. It will be a valuable resource to students and overseas trained pharmacists seeking registration in Australia, as well as to qualified practitioners who seek to better understand the laws and standards that govern the profession. - Unique to the Australian marketplace – presently there is no publication dealing specifically with pharmacy law and ethics in this country - Each chapter includes – learning objectives, review questions and activities, and further readings - The inclusion of quotation from case law – provides an opportunity for readers to learn from history.
Author: Brian Midcalf
Author: Brian Midcalf
Author: 
Author: Standards Association of Australia
Author: Gerard Lee
Author: Hans-Jürgen Bässler
Author: James Agalloco
Author: Tim Coles
Author: Michael Allwood
Author: Tim Sandle
Author: John S. Low