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Author : Alexander Bulloch
Publisher :
ISBN 13 :
Total Pages : 186 pages
Book Rating : 4.:/5 (134 download)
Download or read book Validation of Microprocessor Controlled Steam Sterilization Cycles written by Alexander Bulloch and published by . This book was released on 1985 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Pda Research Task Group on Steam Sterilization
Publisher :
ISBN 13 : 9780939459001
Total Pages : 36 pages
Book Rating : 4.4/5 (59 download)
Download or read book Validation of Steam Sterilization Cycles written by Pda Research Task Group on Steam Sterilization and published by . This book was released on 1978 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Parenteral Drug Association
Publisher :
ISBN 13 :
Total Pages : 36 pages
Book Rating : 4.:/5 (791 download)
Download or read book Validation of Steam Sterilization Cycles written by Parenteral Drug Association and published by . This book was released on 1978 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : James P. Agalloco
Publisher : CRC Press
ISBN 13 : 1420019791
Total Pages : 762 pages
Book Rating : 4.4/5 (2 download)
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1420009419
Total Pages : 1144 pages
Book Rating : 4.4/5 (2 download)
Download or read book Validation Standard Operating Procedures written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2006-05-30 with total page 1144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.0/5 (4 download)
Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : International Validation Forum
Publisher : CRC Press
ISBN 13 : 9780824794590
Total Pages : 1114 pages
Book Rating : 4.7/5 (945 download)
Download or read book Validation Compliance Annual written by International Validation Forum and published by CRC Press. This book was released on 1995-02-17 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Author : Anne F. Booth
Publisher : CRC Press
ISBN 13 : 9781566767569
Total Pages : 142 pages
Book Rating : 4.7/5 (675 download)
Download or read book Sterilization Validation and Routine Operation Handbook written by Anne F. Booth and published by CRC Press. This book was released on 1999-09-01 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.
Author : Anne F Booth
Publisher : CRC Press
ISBN 13 : 1351357565
Total Pages : 155 pages
Book Rating : 4.3/5 (513 download)
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580506321
Total Pages : 50 pages
Book Rating : 4.5/5 (63 download)
Download or read book Sterilization of Medical Devices. Low Temperature Steam and Formaldehyde. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institute Staff and published by . This book was released on 2007-04 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilization (hygiene), Medical equipment, Sterilizers, Steam sterilizers, Low temperatures, Formaldehyde, Quality control, Verification, Specification (approval), Qualification approval, Performance testing, Microbiological analysis, Packaging, Environmental engineering
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580489822
Total Pages : 52 pages
Book Rating : 4.4/5 (898 download)
Download or read book Sterilization of Health Care Products. Moist Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institute Staff and published by . This book was released on 2006-09-29 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Steam, Verification, Quality control, Quality assurance, Acceptance (approval), Installation, Performance, Maintenance, Personnel, Medical instruments, Sterilizers, Steam sterilizers
Author : Frederick J. Carleton
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 728 pages
Book Rating : 4.3/5 (91 download)
Download or read book Validation of Aseptic Pharmaceutical Processes written by Frederick J. Carleton and published by Marcel Dekker. This book was released on 1986 with total page 728 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Gerald E. McDonnell
Publisher : John Wiley & Sons
ISBN 13 : 1444330136
Total Pages : 466 pages
Book Rating : 4.4/5 (443 download)
Download or read book A Practical Guide to Decontamination in Healthcare written by Gerald E. McDonnell and published by John Wiley & Sons. This book was released on 2012-07-23 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resistance, the field of decontamination science is undergoing a major revival. A Practical Guide to Decontamination in Healthcare is a comprehensive training manual, providing practical guidance on all aspects of decontamination including: microbiology and infection control; regulations and standards; containment, transportation, handling, cleaning, disinfection and sterilization of patient used devices; surgical instrumentation; endoscopes; and quality management systems. Written by highly experienced professionals, A Practical Guide to Decontaminationin Healthcare comprises a systematic review of decontamination methods, with uses and advantages outlined for each. Up-to-date regulations, standards and guidelines are incorporated throughout, to better equip healthcare professionals with the information they need to meet the technical and operational challenges of medical decontamination. A Practical Guide to Decontaminationin Healthcare is an important new volume on state-of-the-art decontamination processes and a key reference source for all healthcare professionals working in infectious diseases, infection control/prevention and decontamination services.
Author : British Standards Institution
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (134 download)
Download or read book Sterilization of Health Care Products. Low Temperature Steam and Formaldehyde. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institution and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Adam P. Fraise
Publisher : John Wiley & Sons
ISBN 13 : 1444333259
Total Pages : 626 pages
Book Rating : 4.4/5 (443 download)
Download or read book Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization written by Adam P. Fraise and published by John Wiley & Sons. This book was released on 2013-02-18 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.
Author : Anne F Booth
Publisher : CRC Press
ISBN 13 : 1351357573
Total Pages : 170 pages
Book Rating : 4.3/5 (513 download)
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Author : The Parenteral Society
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (5 download)
Download or read book Validation of Steas Sterilization Cycles written by The Parenteral Society and published by . This book was released on 1978 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
