Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Technology Validation and Current Regulations

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  • Publisher : Woodhead Publishing
  • Release : 13 November 2017
  • ISBN : 0081013604
  • Page : 362 pages
  • Rating : 4.5/5 from 103 voters

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Technology Validation and Current Regulations Book PDF summary

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 inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products

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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations
  • Author : Tim Sandle
  • Publisher : Woodhead Publishing
  • Release Date : 2017-11-13
  • ISBN : 0081013604
DOWNLOAD BOOKSterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations

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

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • ISBN : 9781908818638
DOWNLOAD BOOKSterility, Sterilisation and Sterility Assurance for Pharmaceuticals

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

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 Date : 2019-12-12
  • ISBN : 9780128131794
DOWNLOAD 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

Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices

Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2011
  • ISBN : 8190646745
DOWNLOAD BOOKMicrobiology and Sterility Assurance in Pharmaceuticals and Medical Devices

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
  • Author : Tim Sandle
  • Publisher : Academic Press
  • Release Date : 2018-11-30
  • ISBN : 9780128149126
DOWNLOAD BOOKBiocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher : Woodhead Publishing
  • Release Date : 2015-10-09
  • ISBN : 9780081000441
DOWNLOAD BOOKPharmaceutical Microbiology

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2020-09-02
  • ISBN : 9780128144558
DOWNLOAD BOOKThe Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals,

Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation & Sterilization

Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation & Sterilization
  • Author : Adam P. Fraise,Peter A. Lambert,Jean-Yves Maillard
  • Publisher : John Wiley & Sons
  • Release Date : 2008-04-15
  • ISBN : 9780470755068
DOWNLOAD BOOKRussell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation & Sterilization

Highly respected, established text – a definitive reference in its field – covering in detail many methods of the elimination or prevention of microbial growth "highly recommended to hospital and research personnel, especially to clinical microbiologists, infectioncontrol and environmental-safety specialists, pharmacists, and dieticians." New England Journal of Medicine WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace of change in this area Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical