Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-02-09 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. Includes the most current regulations Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy Offers practical guidance on building a complete biocontamination strategy

Download or read book Contamination Control in Healthcare Product Manufacturing written by Russell Madsen and published by . This book was released on 2018-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical Microbiology written by Tim Sandle and published by Woodhead Publishing. This book was released on 2015-10-09 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Microbial Limit and Bioburden Tests written by Lucia Clontz and published by CRC Press. This book was released on 2008-10-14 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 c

Download or read book Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices written by and published by . This book was released on 2011 with total page 964 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Sterility Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. 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 inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Download or read book Aquatic Ecotoxicology written by Claude Amiard-Triquet and published by Academic Press. This book was released on 2015-06-11 with total page 519 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aquatic Ecotoxicology: Advancing Tools for Dealing with Emerging Risks presents a thorough look at recent advances in aquatic ecotoxicology and their application in assessing the risk of well-known and emerging environmental contaminants. This essential reference, brought together by leading experts in the field, guides users through existing and novel approaches to environmental risk assessment, then presenting recent advances in the field of ecotoxicology, including omics-based technologies, biomarkers, and reference species. The book then demonstrates how these advances can be used to design and perform assays to discover the toxicological endpoints of emerging risks within the aquatic environment, such as nanomaterials, personal care products, PFOS and chemical mixtures. The text is an invaluable reference for any scientist who studies the effects of contaminants on organisms that live within aquatic environments. Provides the latest perspectives on emerging toxic risks to aquatic environments, such as nanomaterials, pharmaceuticals, chemical mixtures, and perfluorooctane sulfonate (PFOS) Offers practical guidance on recent advances to help in choosing the most appropriate toxicological assay Presents case studies and information on a variety of reference species to help put the ecotoxicological theory into practical risk assess

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Download or read book Airborne Biocontaminants and their Impact on Human Health written by Rajeev Singh and published by John Wiley & Sons. This book was released on 2024-09-11 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the relationships between biological contaminants and human health, as well as providing in-depth information of numerous biological contaminants found in diverse settings such as homes, hospitals, businesses, and schools. The current literature study has provided qualitative and quantitative data on bio-contaminants in these diverse indoor contexts. The main objective of this book is to investigate the pattern of morbidity among the people living in industrial, commercial, and residential due to poor air quality. Furthermore, biological sampling data obtained from indoor sites in different seasons provides seasonal adverse health problems explainations. The current study’s findings may aid in the development and implementation of preventative public health programs, as well as the creation of recommendations aimed at creating better indoor settings.

Download or read book The CDC Handbook A Guide to Cleaning and Disinfecting Clean Rooms written by Dr. Tim Sandle and published by Grosvenor House Publishing. This book was released on 2012-08-02 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Ethics Of Chemistry From Poison Gas To Climate Engineering written by Joachim Schummer and published by World Scientific. This book was released on 2021-02-08 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Overall, this collection of case studies provides an outstanding starting point for understanding the ethics of chemistry. It is an extremely important contribution to the study of chemical ethics … Ethics of Chemistry is a key resource for educators interested in integrating ethics instruction into their chemistry curricula … an important foundation for equipping students with the moral judgement and analytical skills necessary to contend with the ethical issues they are likely to face in their professional lives.'Nature Chemistry'… the book offers a general introduction to many relevant topics concerning the values, responsibilities, and judgements in (and of) chemistry. The volume could be helpful for university students and teachers or even general readers interested in the ethics of chemistry.' [Read Full Review]José Ramón Bertomeu-SánchezAmbixAlthough chemistry has been the target of numerous public moral debates for over a century, there is still no academic field of ethics of chemistry to develop an ethically balanced view of the discipline. And while ethics courses are increasingly demanded for science and engineering students in many countries, chemistry is still lagging behind because of a lack of appropriate teaching material. This volume fills both gaps by establishing the scope of ethics of chemistry and providing a cased-based approach to teaching, thereby also narrating a cultural history of chemistry.From poison gas in WWI to climate engineering of the future, this volume covers the most important historical cases of chemistry. It draws lesson from major disasters of the past, such as in Bhopal and Love Canal, or from thalidomide, Agent Orange, and DDT. It further introduces to ethical arguments pro and con by discussing issues about bisphenol-A, polyvinyl chloride, and rare earth elements; as well as of contested chemical projects such as human enhancement, the creation of artificial life, and patents on human DNA. Moreover, it illustrates chemical engagements in preventing hazards, from the prediction of ozone depletion, to Green Chemistry, and research in recycling, industrial substance substitution, and clean-up. Students also learn about codes of conduct and chemical regulations.An international team of experts narrate the historical cases and analyse their ethical dimensions. All cases are suitable for undergraduate teaching, either in classes of ethics, history of chemistry, or in chemistry classes proper.

Download or read book The Performance Economy written by W. Stahel and published by Springer. This book was released on 2010-02-24 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated and revised edition outlines strategies and models for how to use technology and knowledge to improve performance, create jobs and increase income. It shows what skills will be required to produce, sell and manage performance over time, and how manual jobs can contribute to reduce the consumption of non-renewable resources.

Download or read book Molybdenum 99 for Medical Imaging written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-28 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Development of Sustainable Bioprocesses written by Elmar Heinzle and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioprocess technology involves the combination of living matter (whole organism or enzymes ) with nutrients under laboratory conditions to make a desired product within the pharmaceutical, food, cosmetics, biotechnology, fine chemicals and bulk chemicals sectors. Industry is under increasing pressure to develop new processes that are both environmentally friendly and cost-effective, and this can be achieved by taking a fresh look at process development; - namely by combining modern process modeling techniques with sustainability assessment methods. Development of Sustainable Bioprocesses: Modeling and Assessment describes methodologies and supporting case studies for the evolution and implementation of sustainable bioprocesses. Practical and industry-focused, the book begins with an introduction to the bioprocess industries and development procedures. Bioprocesses and bioproducts are then introduced, together with a description of the unit operations involved. Modeling procedures, a key feature of the book, are covered in chapter 3 prior to an overview of the key sustainability assessment methods in use (environmental, economic and societal). The second part of the book is devoted to case studies, which cover the development of bioprocesses in the pharmaceutical, food, fine chemicals, cosmetics and bulk chemicals industries. Some selected case studies include: citric acid, biopolymers, antibiotics, biopharmaceuticals. Supplementary material provides hands-on materials so that the techniques can be put into practice. These materials include a demo version of SuperPro Designer software (used in process engineering) and models of all featured case studies, excel sheets of assessment methods, Monte Carlo simulations and exercises. Previously available on CD-ROM, the supplementary material can now be accessed via http://booksupport.wiley.com by entering the author name, book title or isbn and clicking on the desired entry. This will then give a listing of all the content available for download. Please read any text files before downloading material.

Download or read book Aulton s Pharmaceutics E Book written by Kevin M.G. Taylor and published by Elsevier Health Sciences. This book was released on 2021-04-23 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pharmaceutical Applications written by Ponnadurai Ramasami and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-10-25 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on "The Virtual Conference on Chemistry and its Applications (VCCA-2020) - Research and Innovations in Chemical Sciences: Paving the Way Forward" held in August 2020 and organized by the Computational Chemistry Group of the University of Mauritius. The chapters reflect a wide range of fundamental and applied research in the chemical sciences and interdisciplinary subjects.