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
GET BOOK

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 ...

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
  • Total pages : 964
  • ISBN : 1908818638
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Summary : Read online Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices written by , published by which was released on 2011. Download full Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices Books now! Available in PDF, ePub and Kindle....

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 ...

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Total pages : 760
  • ISBN : 1908818638
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Summary : 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...

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 ...

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 ...

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 ...

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 ...

Advanced Aseptic Processing Technology

Advanced Aseptic Processing Technology
  • Author : James Agalloco,James Akers
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 496
  • ISBN : 1908818638
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Summary : The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing ...

Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based Ambulatory care Medical Surgical and Dental Facilities

Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based  Ambulatory care Medical  Surgical  and Dental Facilities
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1998
  • Total pages : 212
  • ISBN : 1908818638
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Summary : Read online Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based Ambulatory care Medical Surgical and Dental Facilities written by , published by which was released on 1998. Download full Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based Ambulatory care Medical Surgical and Dental Facilities ...

British Pharmaceutical Codex

British Pharmaceutical Codex
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1994
  • Total pages : 212
  • ISBN : 1908818638
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Summary : Read online British Pharmaceutical Codex written by , published by which was released on 1994. Download full British Pharmaceutical Codex Books now! Available in PDF, ePub and Kindle....

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation
  • Author : E. Clyde Buchanan
  • Publisher : Amer Soc of Health System
  • Release Date : 1995
  • Total pages : 182
  • ISBN : 1908818638
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Summary : Read online Principles of Sterile Product Preparation written by E. Clyde Buchanan, published by Amer Soc of Health System which was released on 1995. Download full Principles of Sterile Product Preparation Books now! Available in PDF, ePub and Kindle....

Sterile Drug Products

Sterile Drug Products
  • Author : Michael J. Akers
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 516
  • ISBN : 1908818638
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Summary : Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based ...

Introduction to Sterilization and Disinfection

Introduction to Sterilization and Disinfection
  • Author : Joan F. Gardner,Margaret M. Peel
  • Publisher : Unknown
  • Release Date : 1986
  • Total pages : 183
  • ISBN : 1908818638
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Summary : Read online Introduction to Sterilization and Disinfection written by Joan F. Gardner,Margaret M. Peel, published by which was released on 1986. Download full Introduction to Sterilization and Disinfection Books now! Available in PDF, ePub and Kindle....

USP35 NF30 2012

USP35 NF30  2012
  • Author : United States Pharmacopeial Convention
  • Publisher : U.S. Pharmacopeia
  • Release Date : 2011-11
  • Total pages : 5089
  • ISBN : 1908818638
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Summary : The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug ...