Control Of Particulate Matter Contamination In Healthcare Manufacturing
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Control Of Particulate Matter Contamination In Healthcare Manufacturing
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Author : Thomas A. Barber
language : en
Publisher: CRC Press
Release Date : 1999-10-31
Control Of Particulate Matter Contamination In Healthcare Manufacturing written by Thomas A. Barber and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-10-31 with Medical categories.
Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. He brings together information from over 100 Web sites and other sources and casts it into a practical framework that will help readers ensure their company's success. The book contains thirty-two color photomicrographs and over eighty figures, tables, and charts.
Sterile Product Development
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Author : Parag Kolhe
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-12
Sterile Product Development written by Parag Kolhe and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-12 with Medical categories.
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Analytical Testing For The Pharmaceutical Gmp Laboratory
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Author : Kim Huynh-Ba
language : en
Publisher: John Wiley & Sons
Release Date : 2022-03-31
Analytical Testing For The Pharmaceutical Gmp Laboratory written by Kim Huynh-Ba and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-31 with Science categories.
Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Leachables And Extractables Handbook
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Author : Douglas J. Ball
language : en
Publisher: John Wiley & Sons
Release Date : 2012-01-24
Leachables And Extractables Handbook written by Douglas J. Ball and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-24 with Science categories.
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Developments In Surface Contamination And Cleaning Volume 7
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Author : Rajiv Kohli
language : en
Publisher: William Andrew
Release Date : 2014-11-18
Developments In Surface Contamination And Cleaning Volume 7 written by Rajiv Kohli and has been published by William Andrew this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-18 with Technology & Engineering categories.
As device sizes in the semiconductor industries are shrinking, they become more vulnerable to smaller contaminant particles, and most conventional cleaning techniques employed in the industry are not as effective at smaller scales. The book series Developments in Surface Contamination and Cleaning as a whole provides an excellent source of information on these alternative cleaning techniques as well as methods for characterization and validation of surface contamination. Each volume has a particular topical focus, covering the key techniques and recent developments in the area. The chapters in this Volume address the sources of surface contaminants and various methods for their collection and characterization, as well as methods for cleanliness validation. Regulatory aspects of cleaning are also covered. The collection of topics in this book is unique and complements other volumes in this series. Edited by the leading experts in small-scale particle surface contamination, cleaning and cleaning control, these books will be an invaluable reference for researchers and engineers in R&D, manufacturing, quality control and procurement specification situated in a multitude of industries such as: aerospace, automotive, biomedical, defense, energy, manufacturing, microelectronics, optics and xerography. Provides a state-of-the-art survey and best-practice guidance for scientists and engineers engaged in surface cleaning or handling the consequences of surface contamination Addresses the continuing trends of shrinking device size and contamination vulnerability in a range of industries, spearheaded by the semiconductor industry and others Includes new regulatory aspects
Biophysics For Therapeutic Protein Development
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Author : Linda O. Narhi
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-02-26
Biophysics For Therapeutic Protein Development written by Linda O. Narhi and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-26 with Medical categories.
This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Pharmaceutical Dosage Forms Parenteral Medications
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Author : Sandeep Nema
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Dosage Forms Parenteral Medications written by Sandeep Nema and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the
Gmp Iso Quality Audit Manual For Healthcare Manufacturers And Their Suppliers Volume 2 Regulations Standards And Guidelines
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Author : Leonard Steinborn
language : en
Publisher: CRC Press
Release Date : 2004-12-30
Gmp Iso Quality Audit Manual For Healthcare Manufacturers And Their Suppliers Volume 2 Regulations Standards And Guidelines written by Leonard Steinborn and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-12-30 with Medical categories.
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Air Pollutants In The Context Of One Health
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Author : Sylvester Chibueze Izah
language : en
Publisher: Springer Nature
Release Date : 2024-11-25
Air Pollutants In The Context Of One Health written by Sylvester Chibueze Izah and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-25 with Science categories.
This book reviews air pollutants and their effects on human health, biodiversity, and environmental quality in the context of the One Health framework. Written by experts in the field, the book covers topics such as natural and anthropogenic sources of air pollutants, air pollutants classification based on their chemical composition, physical properties, and origins, and consequences of air pollution on ecosystems, wildlife, and human communities. In this book, readers will find a detailed examination of pollutants, such as particulate matter, volatile organic compounds, and greenhouse gases, and will learn about the mechanisms by which pollutants impact, for instance, the respiratory, cardiovascular, and neurological systems. The book highlights the need for understanding the different pollutants and their One Health effects as a foundation for developing effective regulations, emission controls, cleaner technologies, and promoting lifestyle changes. The book also offers a global perspective on air pollution, and discusses the disproportionate impacts of air pollution on vulnerable populations. In alignment with the United Nations Sustainable Development Goals (SDG), specifically SDG 3 (Good Health and Well-being), SDG 7 (Affordable and Clean Energy), and SDG 11 (Sustainable Cities and Communities), this book takes a focused approach to the One Health implications of various air pollutants and is an important contribution to the global effort to mitigate the impact of air pollution on human health, biodiversity security, and environmental quality. Together with its companion work “Sustainable Strategies for Air Pollution Mitigation”, this book is a valuable resource for students, researchers, policymakers, and anyone seeking a comprehensive perspective on this critical environmental and public health challenge.
Handbook Of Pharmaceutical Manufacturing Formulations
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Author : Safaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Handbook Of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
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