Biocontamination Control For Pharmaceuticals And Healthcare

Author : Tim Sandle
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.15/5 ( download)

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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

Author : Russell Madsen
Publisher :
ISBN 13 : 9781942911326
Total Pages : pages
Book Rating : 4.27/5 ( download)

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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:

Author : Tim Sandle
Publisher : Woodhead Publishing
ISBN 13 : 0081000448
Total Pages : 316 pages
Book Rating : 4.41/5 ( download)

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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 316 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

Author :
Publisher :
ISBN 13 : 9788190646741
Total Pages : 964 pages
Book Rating : 4.45/5 ( download)

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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:

Author : Huagu Ye
Publisher : Springer Nature
ISBN 13 : 9811658803
Total Pages : 580 pages
Book Rating : 4.08/5 ( download)

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Download or read book Common Chinese Materia Medica written by Huagu Ye and published by Springer Nature. This book was released on 2021-12-01 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: This third volume describes 226 species of 32 families of medicinal plants, which are commonly used in Chinese medicine. The most important species are Aquilaria sinensis and Daphne genkwa of Thymelaeaceae; Benincasa hispida, Siraitia grosvenorii, Trichosanthes kirilowii and Trichosanthes rosthornii of Cucurbitaceae; Camellia sinensis of Theaceae; Cleistocalyx operculatus, Eugenia caryophyllata and Rhodomyrtus tomentosa of Myrtaceae; Osbeckia chinensis of Melastomataceae; Quisqualis indica and Terminalia chebula of Combretaceae; Hypericum japonicum of Hypericaceae; Microcos paniculata of Tiliaceae; Hibiscus mutabilis of Malvaceae; Croton crassifolius, C. lachnocarpus, C. tiglium, Euphorbia humifusa, E. lathyris, E. pekinensis, Phyllanthus emblica and Sauropus spatulifolius of Euphorbiaceae. In each specie, it introduces the scientific names, medicinal names, morphologies, habitats, distributions, acquisition and processing methods of these medicinal plants, the content of medicinal properties, therapeutic effects, usage and dosage of these medicinal plants, and attaches unedited color pictures and pictures of part herbal medicines of each species. This book series has 10 volumes in total, which covers over 2000 kinds of Chinese medicines that are commonly used. These volumes not only introduce the efficacy function and some prescriptions of the medicines, but also introduce the biological characteristics of them in detail with clear photos of the habitats, so that readers can identify them in the field. Apart from the growing environment, the books expound the distribution areas and other information to facilitate researches and other applications. The volumes are targeted at readers of general interests and it is also of high referential value for scientific researcher and teachers. It can be used as a guide to researchers, clinical doctors, and students in the department of pharmaceutics and traditional Chinese medicine.

Author : Lucia Clontz
Publisher : CRC Press
ISBN 13 : 1420053493
Total Pages : 344 pages
Book Rating : 4.94/5 ( download)

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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

Author : Tim Sandle
Publisher : Elsevier
ISBN 13 : 1908818638
Total Pages : 370 pages
Book Rating : 4.38/5 ( download)

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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

Author : Claude Amiard-Triquet
Publisher : Academic Press
ISBN 13 : 0128011769
Total Pages : 518 pages
Book Rating : 4.68/5 ( download)

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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 518 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

Author : Rajeev Singh
Publisher : John Wiley & Sons
ISBN 13 : 139417893X
Total Pages : 420 pages
Book Rating : 4.33/5 ( download)

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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.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1384 pages
Book Rating : 4.01/5 ( download)

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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.