November 26, 2020

Download Ebook Free Sterility, Sterilisation And Sterility Assurance For Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
Author : Tim Sandle
Publisher : Elsevier
Release Date : 2013-10-31
Category : Medical
Total pages :362
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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

Pharmaceutical Microbiology

Pharmaceutical Microbiology
Author : Tim Sandle
Publisher : Woodhead Publishing
Release Date : 2015-10-09
Category : Science
Total pages :316
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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 and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios

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
Category : Medical
Total pages :976
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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, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
Author : Tim Sandle
Publisher : Academic Press
Release Date : 2018-11-30
Category : Medical
Total pages :374
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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 to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

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
Category : Technology & Engineering
Total pages :592
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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 guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Validation of Pharmaceutical Processes

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

Hugo and Russell's Pharmaceutical Microbiology

Hugo and Russell's Pharmaceutical Microbiology
Author : Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman
Publisher : John Wiley & Sons
Release Date : 2008-04-15
Category : Medical
Total pages :496
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Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms
Author : Dr. Tim Sandle
Publisher : Grosvenor House Publishing
Release Date : 2012-08-02
Category : Health & Fitness
Total pages :300
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The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
Author : Sophie Lerouge,Anne Simmons
Publisher : Elsevier
Release Date : 2012-09-27
Category : Technology & Engineering
Total pages :352
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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. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices. With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Release Date : 2003-09-02
Category : Medical
Total pages :280
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Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release Date : 2019-11-27
Category : Medical
Total pages :298
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Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

British Pharmaceutical Codex

British Pharmaceutical Codex
Author : Anonim
Publisher : Unknown
Release Date : 1994
Category : Dispensatories
Total pages :129
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Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Author : Safaraz K. Niazi
Publisher : CRC Press
Release Date : 2016-04-19
Category : Medical
Total pages :464
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No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

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
Category : Medical
Total pages :688
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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 practice Gives practical advise on problems of disinfection and antiseptics in hospitals Discusses increasing problems of natural and acquired resistance to antibiotics New contributors give a fresh approach to the subject and ensure international coverage Systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action

Human Microbiology

Human Microbiology
Author : Simon Hardy
Publisher : CRC Press
Release Date : 2002-07-18
Category : Science
Total pages :272
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The widespread presence and activity of micro-organisms makes it impossible to study life sciences without some understanding of microorganisms. Human Microbiology provides a concise review of the biology of the three important groups of micro-organisms that infect humans: bacteria, viruses and fungi. Divided into two parts, it summarises the key features that characterise the physiology of microorganisms e.g. structure and function, growth and division, microbial death and the principles of taxonomy, and examines the common themes that are found in micro-organisms that cause disease in man, the transmission, epidemiology and pathogenicity of microbial diseases. With the overwhelming volume of information published on individual species of bacteria, viruses and fungi, Human Microbiology emphasises the important concepts and themes that occur in the organisms that are pathogenic to humans. The conventional approach to studying medical microbiology tends to result in exhaustive lists of microbes arranged by genus and their associated diseases. To promote understanding of the principles of medical microbiology and avoid memory lessons, the important concepts are discussed with reference to key examples.