Biocontamination Control for Pharmaceutical and Healthcare

Biocontamination Control for Pharmaceutical and Healthcare
Author: Tim Sandle
Publsiher: Academic Press
Total Pages: 250
Release: 2019-01-15
ISBN 10: 9780128149119
ISBN 13: 0128149116
Language: EN, FR, DE, ES & NL

Biocontamination Control for Pharmaceutical and Healthcare Book Review:

Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that tracks through a facility with bio-burden control and reduction at each transition in classified areas; this is a key part of controlling risk escalation to contaminating medicinal products. Regulatory authorities have challenged pharmaceutical and healthcare sectors, and those involved in Good Manufacturing Practice (GMP), to adopt a holistic approach to contamination control. Established ways of assessing contamination are limited, and therefore risk-based approaches are required. As well as using risk to assess types of contamination and where contamination can arise, 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 an up to date and complete biocontamination strategy. Provides the information for a facility to build a complete biocontamination strategy Allows a facility to understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements and reducing process risks Provides insight into developing an environmental monitoring programme Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
Author: Tim Sandle
Publsiher: Academic Press
Total Pages: 374
Release: 2018-11-30
ISBN 10: 0128149124
ISBN 13: 9780128149126
Language: EN, FR, DE, ES & NL

Biocontamination Control for Pharmaceuticals and Healthcare Book Review:

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

Bio Contamination

Bio Contamination
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2014
ISBN 10: 9781905271245
ISBN 13: 1905271247
Language: EN, FR, DE, ES & NL

Bio Contamination Book Review:

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
Author: Tim Sandle
Publsiher: Elsevier
Total Pages: 362
Release: 2013-10-31
ISBN 10: 1908818638
ISBN 13: 9781908818638
Language: EN, FR, DE, ES & NL

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Book Review:

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

Safe Management of Wastes from Health care Activities

Safe Management of Wastes from Health care Activities
Author: A. Prüss,Eric Giroult,Philip Rushbrook
Publsiher: World Health Organization
Total Pages: 230
Release: 1999
ISBN 10: 9789241545259
ISBN 13: 9241545259
Language: EN, FR, DE, ES & NL

Safe Management of Wastes from Health care Activities Book Review:

Aulton s Pharmaceutics E Book

Aulton s Pharmaceutics E Book
Author: Kevin M.G. Taylor,Michael E. Aulton
Publsiher: Elsevier Health Sciences
Total Pages: 968
Release: 2021-04-23
ISBN 10: 0702081566
ISBN 13: 9780702081569
Language: EN, FR, DE, ES & NL

Aulton s Pharmaceutics E Book Book Review:

The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation Designed and written for newcomers to the design and manufacture of dosage forms Relevant pharmaceutical science covered throughout Includes the science of formulation and drug delivery Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines Key points boxes throughout Over 400 online multiple choice questions

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 592
Release: 2020-01-02
ISBN 10: 1119356075
ISBN 13: 9781119356073
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiological Quality Assurance and Control Book Review:

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

An Industrial IoT Approach for Pharmaceutical Industry Growth

An Industrial IoT Approach for Pharmaceutical Industry Growth
Author: Valentina E. Balas,Vijender Kumar Solanki,Raghvendra Kumar
Publsiher: Academic Press
Total Pages: 382
Release: 2020-05-15
ISBN 10: 0128213272
ISBN 13: 9780128213278
Language: EN, FR, DE, ES & NL

An Industrial IoT Approach for Pharmaceutical Industry Growth Book Review:

An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing

Pharmaceutical Microbiology

Pharmaceutical Microbiology
Author: Tim Sandle
Publsiher: Woodhead Publishing
Total Pages: 316
Release: 2015-10-09
ISBN 10: 0081000448
ISBN 13: 9780081000441
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Book Review:

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

Cannabis Laboratory Fundamentals

Cannabis Laboratory Fundamentals
Author: Shaun R. Opie
Publsiher: Springer Nature
Total Pages: 325
Release: 2021-03-09
ISBN 10: 3030627160
ISBN 13: 9783030627164
Language: EN, FR, DE, ES & NL

Cannabis Laboratory Fundamentals Book Review:

The legislative requirement for cannabis to undergo laboratory testing has followed legalization of medical and recreational use in every U.S. state to date. Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space. However, many of the costs, timelines, operational requirements, and compliance issues are overlooked by people who have not been exposed to regulated laboratory testing. Cannabis Laboratory Fundamentals provides an in-depth review of the key issues that impact cannabis testing laboratories and provides recommendations and solutions to avoid common – but expensive – mistakes. The text goes beyond methodology to include sections on economics, regulation, and operational challenges, making it useful for both new and experienced cannabis laboratory operators, as well as all those who want to understand the opportunities and risks of this industry.

WHO Guidelines for Indoor Air Quality

WHO Guidelines for Indoor Air Quality
Author: World Health Organization
Publsiher: WHO Regional Office Europe
Total Pages: 228
Release: 2009
ISBN 10: 9289041684
ISBN 13: 9789289041683
Language: EN, FR, DE, ES & NL

WHO Guidelines for Indoor Air Quality Book Review:

Microbial pollution is a key element of indoor air pollution. It is caused by hundreds of species of bacteria and fungi, in particular filamentous fungi (mould), growing indoors when sufficient moisture is available. This document provides a comprehensive review of the scientific evidence on health problems associated with building moisture and biological agents. The review concludes that the most important effects are increased prevalences of respiratory symptoms, allergies and asthma as well as perturbation of the immunological system. The document also summarizes the available information on the conditions that determine the presence of mould and measures to control their growth indoors. WHO guidelines for protecting public health are formulated on the basis of the review. The most important means for avoiding adverse health effects is the prevention (or minimization) of persistent dampness and microbial growth on interior surfaces and in building structures. [Ed.]

Practical Methods for Biocatalysis and Biotransformations 2

Practical Methods for Biocatalysis and Biotransformations 2
Author: John Whittall,Peter W. Sutton
Publsiher: John Wiley & Sons
Total Pages: 368
Release: 2012-04-25
ISBN 10: 1118307860
ISBN 13: 9781118307861
Language: EN, FR, DE, ES & NL

Practical Methods for Biocatalysis and Biotransformations 2 Book Review:

Biocatalysts are increasingly used by chemists engaged in finechemical synthesis within both industry and academia. Today, thereexists a huge choice of high-tech enzymes and whole cellbiocatalysts, which add enormously to the repertoire of syntheticpossibilities. Practical Methods for Biocatalysis and Biotransformations2 is a "how-to" guide that focuses on the practicalapplications of enzymes and strains of microorganisms that arereadily obtained or derived from culture collections. The sourcesof starting materials and reagents, hints, tips and safety advice(where appropriate) are given to ensure, as far as possible, thatthe procedures are reproducible. Comparisons to alternativemethodology are given and relevant references to the primaryliterature are cited. This second volume – which can be usedon its own or in combination with the first volume - concentrateson new applications and new enzyme families reported since thefirst volume. Contents include: introduction to recent developments and future needs inbiocatalysts and synthetic biology in industry reductive amination enoate reductases for reduction of electron deficientalkenes industrial carbonyl reduction regio- and stereo- selective hydroxylation oxidation of alcohols selective oxidation industrial hydrolases and related enzymes transferases for alkylation, glycosylation andphosphorylation C-C bond formation and decarboxylation halogenation/dehalogenation/heteroatom oxidation tandem and sequential multi-enzymatic syntheses Practical Methods for Biocatalysis and Biotransformations2 is an essential collection of biocatalytic methods forchemical synthesis which will find a place on the bookshelves ofsynthetic organic chemists, pharmaceutical chemists, and processR&D chemists in industry and academia.

Culinary Nutrition

Culinary Nutrition
Author: Jacqueline B. Marcus
Publsiher: Academic Press
Total Pages: 660
Release: 2013-04-15
ISBN 10: 0123918839
ISBN 13: 9780123918833
Language: EN, FR, DE, ES & NL

Culinary Nutrition Book Review:

Culinary Nutrition: The Science and Practice of Healthy Cooking is the first textbook specifically written to bridge the relationship between food science, nutrition and culinology as well as consumer choices for diet, health and enjoyment. The book uses a comprehensive format with real-life applications, recipes and color photographs of finished dishes to emphasize the necessity of sustainably deliverable, health-beneficial and taste-desirable products. With pedagogical elements to enhance and reinforce learning opportunities, this book explores what foods involve the optimum nutritional value for dietary needs, including specific dietary requirements and how foods are produced. It also considers alternative production methods, along with the impact of preparation on both the nutritional value of a food and its consumer acceptability. Other discussions focus on the basics of proteins, carbohydrates, and lipids, issues of diet and disease such as weight management, and food production and preparation. Laboratory-type, in-class activities are presented using limited materials and applications of complex concepts in real-life situations. This book will be a valuable resource for undergraduate students in culinary nutrition, nutrition science, food science and nutrition, and culinary arts courses. It will also appeal to professional chefs and food scientists as well as research chefs in product development. Gourmand World Cookbook Awards 2014: USA, Best Author or Chef for Professionals, Gourmand International Global Food Industry Awards 2014: Special Mention in Communicating Science-Related Knowledge to Consumers Aimed at Improving their Lifestyle, International Union of Food Science and Technology (IUFoST) Explores the connections among the technical sciences of nutrition, food science and the culinary arts as well as consumer choices for diet, health and enjoyment Presents laboratory-type, in-class activities using limited materials and real-life applications of complex concepts Includes photographs and recipes to enhance learning experience

Microbial Limit and Bioburden Tests

Microbial Limit and Bioburden Tests
Author: Lucia Clontz
Publsiher: CRC Press
Total Pages: 280
Release: 2008-10-14
ISBN 10: 9781420053494
ISBN 13: 1420053493
Language: EN, FR, DE, ES & NL

Microbial Limit and Bioburden Tests Book Review:

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies. Includes New and Updated Material Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation. Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

Cleanroom Technology

Cleanroom Technology
Author: William Whyte
Publsiher: John Wiley & Sons
Total Pages: 384
Release: 2010-03-01
ISBN 10: 0470748060
ISBN 13: 9780470748060
Language: EN, FR, DE, ES & NL

Cleanroom Technology Book Review:

A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination… This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme. Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries. William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology. A comment on the first edition: "...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)

Molybdenum 99 for Medical Imaging

Molybdenum 99 for Medical Imaging
Author: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Nuclear and Radiation Studies Board,Committee on State of Molybdenum-99 Production and Utilization and Progress Toward Eliminating Use of Highly Enriched Uranium
Publsiher: National Academies Press
Total Pages: 263
Release: 2016-11-28
ISBN 10: 0309445310
ISBN 13: 9780309445313
Language: EN, FR, DE, ES & NL

Molybdenum 99 for Medical Imaging Book Review:

The decay product of the medical isotope molybdenum-99 (Mo-99), technetium-99m (Tc-99m), and associated medical isotopes iodine-131 (I-131) and xenon-133 (Xe-133) are used worldwide for medical diagnostic imaging or therapy. The United States consumes about half of the world's supply of Mo-99, but there has been no domestic (i.e., U.S.-based) production of this isotope since the late 1980s. The United States imports Mo-99 for domestic use from Australia, Canada, Europe, and South Africa. Mo-99 and Tc-99m cannot be stockpiled for use because of their short half-lives. Consequently, they must be routinely produced and delivered to medical imaging centers. Almost all Mo-99 for medical use is produced by irradiating highly enriched uranium (HEU) targets in research reactors, several of which are over 50 years old and are approaching the end of their operating lives. Unanticipated and extended shutdowns of some of these old reactors have resulted in severe Mo-99 supply shortages in the United States and other countries. Some of these shortages have disrupted the delivery of medical care. Molybdenum-99 for Medical Imaging examines the production and utilization of Mo-99 and associated medical isotopes, and provides recommendations for medical use.

The International Pharmacopoeia

The International Pharmacopoeia
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 1499
Release: 2006
ISBN 10: 924156301X
ISBN 13: 9789241563017
Language: EN, FR, DE, ES & NL

The International Pharmacopoeia Book Review:

A collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances, excipients and dosage forms intended to serve as source material for reference by any WHO member state.

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 1420019791
ISBN 13: 9781420019797
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

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

Biosafety in the Laboratory

Biosafety in the Laboratory
Author: Division on Engineering and Physical Sciences,Commission on Physical Sciences, Mathematics, and Applications,Committee on Hazardous Biological Substances in the Laboratory,National Research Council
Publsiher: National Academies Press
Total Pages: 244
Release: 1989-01-01
ISBN 10: 0309039754
ISBN 13: 9780309039758
Language: EN, FR, DE, ES & NL

Biosafety in the Laboratory Book Review:

Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safety--and more.

Quality Assurance of Aseptic Preparation Services Standards Handbook

Quality Assurance of Aseptic Preparation Services Standards Handbook
Author: Alison M. Beaney
Publsiher: Unknown
Total Pages: 250
Release: 2016-10-03
ISBN 10: 9780857113078
ISBN 13: 0857113070
Language: EN, FR, DE, ES & NL

Quality Assurance of Aseptic Preparation Services Standards Handbook Book Review:

Standards for unlicensed aseptic preparation in the UK, as well as practical information for implementing the standards.