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Sterilization Validation and Routine Operation Handbook

Sterilization Validation and Routine Operation Handbook
Author: Anne F. Booth
Publisher: CRC Press
Total Pages: 142
Release: 1999-09-01
Genre: Medical
ISBN: 9781566767569

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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.


Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition
Author: James Agalloco
Publisher: CRC Press
Total Pages: 1062
Release: 2021-10-28
Genre: Medical
ISBN: 1000436012

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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


Advanced Monitoring and Procedures for Small Animal Emergency and Critical Care

Advanced Monitoring and Procedures for Small Animal Emergency and Critical Care
Author: Jamie M. Burkitt Creedon
Publisher: John Wiley & Sons
Total Pages: 896
Release: 2012-04-03
Genre: Medical
ISBN: 1118242084

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Advanced Monitoring and Procedures for Small Animal Emergency and Critical Care is a comprehensive yet practical reference, providing hands-on information essential to veterinarians and veterinary technicians involved in emergency and critical care. Written by an expert team of veterinarians and veterinary technicians, this well-referenced book offers step-by-step protocols for performing advanced emergency and critical care procedures and monitoring techniques. Packed with practical guidance in an easy-to-use format, this book is ideally suited for quick access in emergency rooms or intensive care units. Organized primarily by body system, each chapter covers general principles, indications, equipment, techniques, basic interpretation, troubleshooting, and contraindications. Standardized protocols supply equipment lists and step-by-step instructions throughout, and a companion website offers images from the book in PowerPoint and protocols as downloadable Word files. Advanced Monitoring and Procedures for Small Animal Emergency and Critical Care is a valuable resource for any veterinary staff member with an interest in improving the standard of care in emergency and critical care medicine.


Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
Author: Sophie Lerouge
Publisher: Elsevier
Total Pages: 347
Release: 2012-09-27
Genre: Medical
ISBN: 0857096265

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The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices


Preventing Worker Injuries and Deaths from Explosions in Industrial Ethylene Oxide Sterilization Facilities

Preventing Worker Injuries and Deaths from Explosions in Industrial Ethylene Oxide Sterilization Facilities
Author: Barry Leonard
Publisher: DIANE Publishing
Total Pages: 360
Release: 2008-04
Genre: Technology & Engineering
ISBN: 1428988998

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Industrial ethylene oxide (EtO) is among the top 3% of high-vol. chemicals produced in the U.S. Industry has long recognized the value of safe, effective, & efficient sterilization using EtO. The health care & food industries depend on the EtO sterilization industry for sterile products. Oxidizing emission control devices (OECDs) are integrated into some sterilization systems. They remove or destroy small amounts of EtO remaining in a vent stream through oxidation or burning. The EtO concentration in the vent stream must remain well below the flammable or explosive range because OECDs provide a source of ignition that could trigger an explosion in the vent system. This report explains this problem & makes recommendations for protecting workers.