Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Written By Tim Sandle
Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
  • Publsiher : Elsevier
  • Release : 31 October 2013
  • ISBN : 1908818638
  • Pages : 362 pages
  • Rating : 5/5 from 1 reviews
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Download or read book entitled Sterility Sterilisation and Sterility Assurance for Pharmaceuticals by author: Tim Sandle which was release on 31 October 2013 and published by Elsevier with total page 362 pages . This book available in PDF, EPUB and Kindle Format. 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

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 362
  • ISBN : 1908818638
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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 ...

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher : Woodhead Publishing
  • Release Date : 2015-10-09
  • Total pages : 316
  • ISBN : 1908818638
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Summary : 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 ...

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
  • Total pages : 976
  • ISBN : 1908818638
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Summary : 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 ...

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
  • Author : Tim Sandle
  • Publisher : Academic Press
  • Release Date : 2018-11-30
  • Total pages : 374
  • ISBN : 1908818638
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Summary : 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 ...

Dosage Form Design Parameters

Dosage Form Design Parameters
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-25
  • Total pages : 810
  • ISBN : 1908818638
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Summary : Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in ...

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release Date : 2020-01-02
  • Total pages : 592
  • ISBN : 1908818638
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Summary : Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides ...

Handbook of Hygiene Control in the Food Industry

Handbook of Hygiene Control in the Food Industry
  • Author : H. L. M. Lelieveld,John Holah,Domagoj Gabric
  • Publisher : Woodhead Publishing
  • Release Date : 2016-06-10
  • Total pages : 756
  • ISBN : 1908818638
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Summary : Handbook of Hygiene Control in the Food Industry, Second Edition, continues to be an authoritative reference for anyone who needs hands-on practical information to improve best practices in food safety and quality. The book is written by leaders in the field who understand the complex issues of control surrounding food ...

ESR Spectroscopy for Life Science Applications An Introduction

ESR Spectroscopy for Life Science Applications  An Introduction
  • Author : Ashutosh Kumar Shukla
  • Publisher : Springer Nature
  • Release Date : 2021-04-20
  • Total pages : 72
  • ISBN : 1908818638
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Summary : This installment in the Techniques in Life Science and Biomedicine for the Non-Expert series aims to describe ESR spectroscopy as a tool for different applications, such as Healthcare & Pharmaceutical Science, Paleontology & Geochronology and Food Science. In keeping with the series theme, this text is presented in such a manner that ...

Cost Analysis Of Terminal Sterilization And Aseptic Processing Methods Of Sensitive Implantable Combination Drug Device Products

Cost Analysis Of Terminal Sterilization And Aseptic Processing Methods Of Sensitive Implantable Combination Drug Device Products
  • Author : Zenabu Bawa-Mamudu
  • Publisher : Unknown
  • Release Date : 2015
  • Total pages : 15
  • ISBN : 1908818638
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Summary : Executive Summary Cost Analysis of Terminal Sterilization and Aseptic Processing Methods of Sensitive Implantable Combination Drug Device Products Company X Zenabu Bawa-Mamudu - 4/24/2015 Professional Science Master's in Biotechnology, California State University San Marcos Sterilization is the validated process and method of ensuring that a product after production and packaging is ...

Drug Delivery Aspects

Drug Delivery Aspects
  • Author : Ranjita Shegokar
  • Publisher : Academic Press
  • Release Date : 2020-04-10
  • Total pages : 278
  • ISBN : 1908818638
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Summary : Drug Delivery Aspects: Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, and scale-up of nano and micro carriers. Various aspects like conversion of micro-nano particles into solid dosage form, large scale industry manufacturing challenges of nanocarriers, regulatory considerations on drug device combinations are featured in this ...

Endotoxin Detection and Control in Pharma Limulus and Mammalian Systems

Endotoxin Detection and Control in Pharma  Limulus  and Mammalian Systems
  • Author : Kevin L. Williams
  • Publisher : Springer
  • Release Date : 2019-07-24
  • Total pages : 869
  • ISBN : 1908818638
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Summary : Endotoxin detection and control is a dynamic area of applied science that touches a vast number of complex subjects. The intersection of test activities includes the use of an ancient blood system from an odd “living fossil” (Limulus). It is used to detect remnants of the most primitive and destructive ...

Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II
  • Author : Michael J. Groves,Ram Murty
  • Publisher : CRC Press
  • Release Date : 1995-05-31
  • Total pages : 520
  • ISBN : 1908818638
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Summary : Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic ...

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials
  • Author : Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
  • Publisher : Academic Press
  • Release Date : 2019-06-15
  • Total pages : 252
  • ISBN : 1908818638
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Summary : 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 ...

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
  • Total pages : 262
  • ISBN : 1908818638
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Summary : 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 ...

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release Date : 2014-08-22
  • Total pages : 780
  • ISBN : 1908818638
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Summary : Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant ...