Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient’s best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Produk Detail:

  • Author : Byron J. Lambert
  • Publisher : Academic Press
  • Pages : 262 pages
  • ISBN : 0128131799
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKAssurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
  • Author : Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
  • Publisher : Academic Press
  • Release : 12 December 2019
GET THIS BOOKAssurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient’s best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
  • Author : Sophie Lerouge,Anne Simmons
  • Publisher : Elsevier
  • Release : 27 September 2012
GET THIS BOOKSterilisation of Biomaterials and Medical Devices

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.

ANSI/AAMI St79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

ANSI/AAMI St79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
  • Author : Aami
  • Publisher : Association for the Advancement of Medical Instrumentation (AAMI)
  • Release : 01 October 2013
GET THIS BOOKANSI/AAMI St79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a

Sterilization Manual for Health Centers

Sterilization Manual for Health Centers
  • Author : Silvia I. Acosta-Gnass,Valeska De Andrade Stempliuk
  • Publisher : Pan Amer Health Org
  • Release : 07 August 2022
GET THIS BOOKSterilization Manual for Health Centers

This updated sterilisation manual informs health workers about the simple protocols and procedures that have been developed to prevent hospital-acquired infections both inside and outside the sterilisation plant. The guidelines included in this manual show the steps to follow in cleaning, preparing, sterilizing, storing and transporting hospital equipment so as to obtain sterile material. It is very important to be aware of this information in order to provide patients with safe health care.

Democracy and Education

Democracy and Education
  • Author : John Dewey
  • Publisher : Unknown Publisher
  • Release : 07 August 2022
GET THIS BOOKDemocracy and Education

John Dewey's Democracy and Education addresses the challenge of providing quality public education in a democratic society. In this classic work Dewey calls for the complete renewal of public education, arguing for the fusion of vocational and contemplative studies in education and for the necessity of universal education for the advancement of self and society. First published in 1916, Democracy and Education is regarded as the seminal work on public education by one of the most important scholars of the century.

The International Pharmacopoeia

The International Pharmacopoeia
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 07 August 2022
GET THIS BOOKThe International Pharmacopoeia

A collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients and dosage forms intended to serve as source material for reference by any WHO member state.

Thermal Processing of Food

Thermal Processing of Food
  • Author : Senate Commission on Food Safety SKLM
  • Publisher : John Wiley & Sons
  • Release : 24 September 2007
GET THIS BOOKThermal Processing of Food

This is the latest and most authoritative documentation of current scientific knowledge regarding the health effects of thermal food processing. Authors from all over Europe and the USA provide an international perspective, weighing up the risks and benefits. In addition, the contributors outline those areas where further research is necessary.

Sterile Services Department

Sterile Services Department
  • Author : NHS Estates,NHS Estates Staff
  • Publisher : The Stationery Office
  • Release : 07 August 2022
GET THIS BOOKSterile Services Department

Provides guidance to help health planners, estates and facilities managers, sterile services managers and capital planning and design teams to plan and design a sterile services department. It discusses the objectives of a sterile services department (SSD) and service requirements, particularly focusing on: raising standards in decontamination services by optimising the built environment: service requirements strategy: calculating the optimum capacity of an SSD to eradicate bottlenecks: determining the most appropriate location of an SSD. Design guidance based on the above

Infection Control and Management of Hazardous Materials for the Dental Team-E-Book

Infection Control and Management of Hazardous Materials for the Dental Team-E-Book
  • Author : Chris H. Miller,Charles John Palenik
  • Publisher : Elsevier Health Sciences
  • Release : 18 March 2014
GET THIS BOOKInfection Control and Management of Hazardous Materials for the Dental Team-E-Book

Maintain safety and infection control in the dental office with Infection Control and Management of Hazardous Materials for the Dental Team, Fourth Edition. This practical and comprehensive resource covers the basic concepts of infectious disease and infection control, including step-by-step descriptions of specific procedures and supplies and equipment needed for disease prevention. The Fourth Edition features new chapters on the latest topics impacting office safety and the most current regulatory recommendations for protection of dental patients and dental workers. No

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy
  • Author : Mahmoud Aljurf,John A. Snowden,Patrick Hayden,Kim H. Orchard,Eoin McGrath
  • Publisher : Springer Nature
  • Release : 19 February 2021
GET THIS BOOKQuality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy

This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management

Pharmaceutical Microbiology Manual

Pharmaceutical Microbiology Manual
  • Author : United States Food and Drug Administration
  • Publisher : Createspace Independent Publishing Platform
  • Release : 21 September 2017
GET THIS BOOKPharmaceutical Microbiology Manual

Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM

Laboratory Biosafety Manual

Laboratory Biosafety Manual
  • Author : World Health Organisation Staff,World Health Organization
  • Publisher : World Health Organization
  • Release : 28 December 2004
GET THIS BOOKLaboratory Biosafety Manual

This is the third edition of this manual which contains updated practical guidance on biosafety techniques in laboratories at all levels. It is organised into nine sections and issues covered include: microbiological risk assessment; lab design and facilities; biosecurity concepts; safety equipment; contingency planning; disinfection and sterilisation; the transport of infectious substances; biosafety and the safe use of recombinant DNA technology; chemical, fire and electrical safety aspects; safety organisation and training programmes; and the safety checklist.