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Author: Tim Sandle Publisher: Elsevier ISBN: 0443216010 Category : Medical Languages : en Pages : 510
Book Description
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: Tim Sandle Publisher: Elsevier ISBN: 0443216010 Category : Medical Languages : en Pages : 510
Book Description
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: Stephen P. Denyer Publisher: CRC Press ISBN: 1420021621 Category : Science Languages : en Pages : 500
Book Description
Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.
Author: Michael J. Groves Publisher: CRC Press ISBN: 1000161676 Category : Medical Languages : en Pages : 544
Book Description
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
Author: Tim Sandle Publisher: Woodhead Publishing ISBN: 0081000448 Category : Science Languages : en Pages : 316
Book Description
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: Lucia Clontz Publisher: CRC Press ISBN: 9781420053494 Category : Science Languages : en Pages : 280
Book Description
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.
Author: Huagu Ye Publisher: Springer Nature ISBN: 9811658803 Category : Medical Languages : en Pages : 580
Book Description
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: Michael K. Akers Publisher: CRC Press ISBN: 0824745663 Category : Medical Languages : en Pages : 401
Book Description
Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to test
Author: Tim Sandle
Author: Tim Sandle
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Author: Stephen P. Denyer
Author: Russell Madsen
Author: Michael J. Groves
Author: Tim Sandle
Author: Lucia Clontz
Author: 
Author: Huagu Ye
Author: Michael K. Akers