Sterility Sterilisation And Sterility Assurance For Pharmaceuticals

Author : Tim Sandle
Publisher : Woodhead Publishing
Page : 362 pages
File Size : 55,8 Mb
Release : 2017-11-13
Category : Business & Economics
ISBN : 0081013604

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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations by Tim Sandle Pdf

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 inactivationIncludes discussion of medical devices, aseptically filled products and terminally sterilised productsDescribes bacterial, pyrogenic, and endotoxin risks to devices and products

Author : Tim Sandle
Publisher : Elsevier
Page : 362 pages
File Size : 40,7 Mb
Release : 2013-10-31
Category : Medical
ISBN : 9781908818638

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Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by Tim Sandle Pdf

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 : Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans
Publisher : Academic Press
Page : 268 pages
File Size : 47,8 Mb
Release : 2019-11-30
Category : Technology & Engineering
ISBN : 9780128131794

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Assurance of Sterility for Sensitive Combination Products and Materials by Byron J. Lambert,Stan Lam,Joyce M. Hansen,Trabue D. Bryans Pdf

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient’s best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Author : Center for Drugs and Biologics (U.S.)
Publisher : Unknown
Page : 48 pages
File Size : 45,8 Mb
Release : 1987
Category : Asepsis and antisepsis
ISBN : UOM:39015029714741

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Guideline on Sterile Drug Products Produced by Aseptic Processing by Center for Drugs and Biologics (U.S.) Pdf

Author : Anonim
Publisher : Unknown
Page : 964 pages
File Size : 49,5 Mb
Release : 2011
Category : Pharmaceutical microbiology
ISBN : 8190646745

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Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices by Anonim Pdf

Author : Michael J. Groves,Ram Murty
Publisher : CRC Press
Page : 544 pages
File Size : 48,7 Mb
Release : 1995-05-31
Category : Medical
ISBN : 0935184775

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Aseptic Pharmaceutical Manufacturing II by Michael J. Groves,Ram Murty Pdf

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 : T. D. Whittet,W. B. Hugo,G. R. Wilkinson
Publisher : Elsevier
Page : 288 pages
File Size : 53,6 Mb
Release : 2013-10-22
Category : Medical
ISBN : 9781483196138

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Sterilisation and Disinfection by T. D. Whittet,W. B. Hugo,G. R. Wilkinson Pdf

Pharmaceutical Monographs, Volume 3: Sterilisation and Disinfection provides a strong foundation for the proper use of disinfectants in practice. This monograph surveys the types of preparations required to be produced in a sterile condition and explains in detail the methods available for sterilization. This monograph is comprised of four parts. Part 1 discusses the purposes of sterilizing pharmaceutical preparations to prevent the infection of body tissues, fluids, or cavities with organisms that may produce damage or disease. Part 2 provides information concerning the extent of contamination of pharmaceutical materials, which is obtained by means of sterility tests. Part 3 focuses on autoclave design and an explanation is offered of the background against which sterilizers have been developed and the method in which their major components operate. Part 4 describes the various types of disinfectants, including halogens, phenols, alcohols, aldehydes, dyes, furan derivatives, amidines, surface-active compounds, and derivatives of quinolone and isoquinoline. This monograph is a valuable resource for undergraduate students of pharmacy and allied subjects.

Author : Nigel Halls
Publisher : CRC Press
Page : 296 pages
File Size : 43,9 Mb
Release : 1994-05-10
Category : Medical
ISBN : 0824790146

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Achieving Sterility in Medical and Pharmaceutical Products by Nigel Halls Pdf

Detailing the scientific principles underlying the achievement of sterility, this unique reference examines both a broad spectrum of practical, commonly used sterilization procedures and the methods available to confirm sterility-assessing the strengths and limitations of each technology. Delineates current regulatory requirements for sterility-emphasizing the importance of aseptic processes in the medical establishment and the pharmaceutical industry! Achieving Sterility in Medical and Pharmaceutical Products discusses sterilization approaches that utilize saturated steam dry heat ethylene oxide gamma radiation sterile filtration and more!

Author : Association for the Advancement of Medical Instrumentation
Publisher : Unknown
Page : 52 pages
File Size : 49,6 Mb
Release : 1998
Category : Health facilities
ISBN : UOM:39015058874069

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Steam Sterilization and Sterility Assurance Using Table-top Sterilizers in Office-based, Ambulatory-care Medical, Surgical, and Dental Facilities by Association for the Advancement of Medical Instrumentation Pdf

Author : Anonim
Publisher : Unknown
Page : 38 pages
File Size : 46,9 Mb
Release : 1988
Category : Steam as a disinfectant
ISBN : 0910275777

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Good Hospital Practice by Anonim Pdf

Author : Jeanne Moldenhauer
Publisher : Unknown
Page : 725 pages
File Size : 50,7 Mb
Release : 2002
Category : Electronic
ISBN : 1930114389

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Steam Sterilization by Jeanne Moldenhauer Pdf

Author : Michael J Groves,Ram Murty
Publisher : CRC Press
Page : 520 pages
File Size : 55,8 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 0367401738

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Aseptic Pharmaceutical Manufacturing by Michael J Groves,Ram Murty Pdf

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 : Anonim
Publisher : Academic Press
Page : 974 pages
File Size : 48,7 Mb
Release : 2020-09-02
Category : Medical
ISBN : 9780128144558

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The Future of Pharmaceutical Product Development and Research by Anonim Pdf

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 45,6 Mb
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 9781119356073

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Pharmaceutical Microbiological Quality Assurance and Control by David Roesti,Marcel Goverde Pdf

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

Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Page : 1435 pages
File Size : 49,7 Mb
Release : 2019-04-08
Category : Technology & Engineering
ISBN : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry by Mary T. am Ende,David J. am Ende Pdf

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.