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

Written By Tim Sandle
Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals  Technology  Validation and Current Regulations
  • Publsiher : Woodhead Publishing
  • Release : 13 November 2017
  • ISBN : 9780081013601
  • Pages : 362 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Technology Validation and Current Regulations written by Tim Sandle which was release on 13 November 2017, this book published by Woodhead Publishing. Available in PDF, EPUB and Kindle Format. Book excerpt: 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

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
  • Total pages : 362
  • ISBN : 9780081013601
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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 ...

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 : 9780081013601
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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 ...

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 : 9780081013601
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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 ...

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher : Woodhead Publishing
  • Release Date : 2015-10-09
  • Total pages : 316
  • ISBN : 9780081013601
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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 : 9780081013601
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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 ...

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 : 9780081013601
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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 : 9780081013601
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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 ...

Dosage Form Design Parameters

Dosage Form Design Parameters
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-25
  • Total pages : 810
  • ISBN : 9780081013601
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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 ...

Quality Assurance

Quality Assurance
  • Author : G Welty
  • Publisher : Elsevier
  • Release Date : 2013-06-30
  • Total pages : 374
  • ISBN : 9780081013601
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Summary : Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which ...

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 : 9780081013601
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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 ...

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
  • Author : J E Aguilar
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • Total pages : 304
  • ISBN : 9780081013601
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Summary : A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. ...

Biopharmaceutical Manufacturing

Biopharmaceutical Manufacturing
  • Author : Gary Gilleskie,Charles Rutter,Becky McCuen
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release Date : 2021-09-07
  • Total pages : 347
  • ISBN : 9780081013601
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Summary : Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the ...

Bioinformatics for Biomedical Science and Clinical Applications

Bioinformatics for Biomedical Science and Clinical Applications
  • Author : K-H Liang
  • Publisher : Elsevier
  • Release Date : 2013-07-31
  • Total pages : 170
  • ISBN : 9780081013601
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Summary : Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for ...

From Plant Genomics to Plant Biotechnology

From Plant Genomics to Plant Biotechnology
  • Author : Palmiro Poltronieri,Natalija Burbulis,Corrado Fogher
  • Publisher : Elsevier
  • Release Date : 2013-08-31
  • Total pages : 274
  • ISBN : 9780081013601
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Summary : With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology. From plant genomics ...

Marine Enzymes for Biocatalysis

Marine Enzymes for Biocatalysis
  • Author : Antonio Trincone
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • Total pages : 576
  • ISBN : 9780081013601
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Summary : Marine bioprospecting is a highly topical subject - in both applied and basic research - but, as yet, the marine ecosystem is a relatively unexplored source of natural bioactive substances with potential therapeutic activity. This book addresses the use of marine enzymes in biocatalysis through a series of chapters from ...