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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher :Unknown
  • Release Date :2013-10-31
  • Total pages :362
  • ISBN : 9781908818638
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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 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

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2020-09-02
  • Total pages :976
  • ISBN : 9780128144558
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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 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

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher :Unknown
  • Release Date :2015-10-09
  • Total pages :316
  • ISBN : 9780081000441
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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 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

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
  • Author : Tim Sandle
  • Publisher :Unknown
  • Release Date :2018-11-30
  • Total pages :374
  • ISBN : 9780128149126
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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 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 :Unknown
  • Release Date :2020-01-02
  • Total pages :592
  • ISBN : 9781119356073
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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 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

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 :Unknown
  • Release Date :2016-06-10
  • Total pages :756
  • ISBN : 9780081001974
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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 industry design, operations, and processes, contamination management methods, route analysis processing, allergenic residues, pest management, and more. Professionals and students will find a comprehensive account of risk analysis and management solutions they can use to minimize risks and hazards plus tactics and best practices for creating a safe food supply, farm to fork. Presents the latest research and development in the field of hygiene, offering a broad range of the microbiological risks associated with food processing Provides practical hygiene related solutions in food facilities to minimize foodborne pathogens and decrease the occurrence of foodborne disease Includes the latest information on biofilm formation and detection for prevention and control of pathogens as well as pathogen resistance

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher :Unknown
  • Release Date :2007-09-25
  • Total pages :760
  • ISBN : 1420019791
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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

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 :Unknown
  • Release Date :2012-08-02
  • Total pages :300
  • ISBN : 9781781480809
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Summary : 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 :Unknown
  • Release Date :2012-09-27
  • Total pages :352
  • ISBN : 9780857096265
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Summary : 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 :Unknown
  • Release Date :2003-09-02
  • Total pages :280
  • ISBN : 0203305191
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Summary : 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.

British Pharmaceutical Codex

British Pharmaceutical Codex
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1994
  • Total pages :229
  • ISBN : UOM:39015030886520
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Summary :

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
  • Author : Safaraz K. Niazi
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :464
  • ISBN : 9781420081312
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Summary : 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

Human Microbiology

Human Microbiology
  • Author : Simon Hardy
  • Publisher :Unknown
  • Release Date :2002-07-18
  • Total pages :272
  • ISBN : 0415241685
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Summary : 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.

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 :Unknown
  • Release Date :2008-04-15
  • Total pages :688
  • ISBN : 9780470755068
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Summary : 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

Isolation Technology

Isolation Technology
  • Author : Tim Coles
  • Publisher :Unknown
  • Release Date :2004-05-27
  • Total pages :240
  • ISBN : 1420025848
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Summary : The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: " Descriptions of and comments on new guidelines and standards " Technological advances - such as the new breed of sanitizing gas generators " Updates that reflect current thinking and new information Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.

Practical Pharmaceutics

Practical Pharmaceutics
  • Author : Yvonne Bouwman-Boer,V'Iain Fenton-May,Paul Le Brun
  • Publisher :Unknown
  • Release Date :2015-08-24
  • Total pages :878
  • ISBN : 9783319158143
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Summary : This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.

Biopharmaceutical Processing

Biopharmaceutical Processing
  • Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
  • Publisher :Unknown
  • Release Date :2018-01-18
  • Total pages :1308
  • ISBN : 9780128125526
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Summary : Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Risk Management and Risk Assessment for Pharmaceutical Manufacturing

Risk Management and Risk Assessment for Pharmaceutical Manufacturing
  • Author : Dr Tim Sandle
  • Publisher :Unknown
  • Release Date :2013-06-01
  • Total pages :168
  • ISBN : 1482596148
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Summary : This book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.

An Introduction to Pharmaceutical Formulation

An Introduction to Pharmaceutical Formulation
  • Author : A. G. Fishburn
  • Publisher :Unknown
  • Release Date :2013-10-22
  • Total pages :200
  • ISBN : 9781483138534
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Summary : An Introduction to Pharmaceutical Formulation describes the various forms in which drugs may be supplied to doctors, patients, and veterinary surgeons. An account is given of the materials which may be added to drugs in order to provide formulated products, and of the methods by which formulations are assessed. The book begins with a background on pharmaceutical formulation, describing manufactured and official formulations, important criteria for a formulation, and technical advances in pharmacy during the post-war period. This is followed by separate chapters on diluents, solvents, and liquid vehicles; thickeners and binders; the chemistry and pharmacology of surface-active agents; and colors, flavors, and preservatives. Subsequent chapters cover solid, liquid, and paste formulations; controlled drug release; the stability of formulations; the importance of the container of the formulation; and large-scale manufacturing of formulated products. This book is intended primarily for students of pharmacy. It is not a textbook of practical or theoretical pharmaceutics but should be read in conjunction with other books on these subjects.

Laboratory Methods in Microbiology

Laboratory Methods in Microbiology
  • Author : W. F. Harrigan,Margaret E. McCance
  • Publisher :Unknown
  • Release Date :2014-06-28
  • Total pages :374
  • ISBN : 9781483274348
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Summary : Laboratory Methods in Microbiology is a laboratory manual based on the experience of the authors over several years in devising and organizing practical classes in microbiology to meet the requirements of students following courses in microbiology at the West of Scotland Agricultural College. The primary object of the manual is to provide a laboratory handbook for use by students following food science, dairying, agriculture and allied courses to degree and diploma level, in addition to being of value to students reading microbiology or general bacteriology. It is hoped that laboratory workers in the food manufacturing and dairying industries will find the book useful in the microbiological aspects of quality control and production development. The book is organized into two parts. Part I is concerned with basic methods in microbiology and would normally form the basis of a first year course. Abbreviated recipes and formulations for a number of typical media and reagents are included where appropriate, so that the principles involved are more readily apparent. Part II consists of an extension of these basic methods into microbiology as applied in the food manufacturing, dairying and allied industries. In this part, the methods in current use are given in addition to, or in place of, the ""classical"" or conventional techniques.

Hugo and Russell's Pharmaceutical Microbiology

Hugo and Russell's Pharmaceutical Microbiology
  • Author : Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman
  • Publisher :Unknown
  • Release Date :2008-04-15
  • Total pages :496
  • ISBN : 9781405141031
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Summary : 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