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Sterility Sterilisation And Sterility Assurance For Pharmaceuticals

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Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals Book
Author : Tim Sandle
Publisher : Elsevier
Release : 2013-10-31
ISBN : 1908818638
Language : En, Es, Fr & De

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Book Description :

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

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research Book
Author : Anonim
Publisher : Academic Press
Release : 2020-09-02
ISBN : 0128144556
Language : En, Es, Fr & De

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Book Description :

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

Pharmaceutical Microbiology

Pharmaceutical Microbiology Book
Author : Tim Sandle
Publisher : Woodhead Publishing
Release : 2015-10-09
ISBN : 0081000448
Language : En, Es, Fr & De

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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

Achieving Sterility in Medical and Pharmaceutical Products

Achieving Sterility in Medical and Pharmaceutical Products Book
Author : Nigel Halls
Publisher : Marcel Dekker
Release : 1994-05-10
ISBN : 9780824790141
Language : En, Es, Fr & De

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Book Description :

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!

Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II Book
Author : Michael J. Groves,Ram Murty
Publisher : CRC Press
Release : 1995-05-31
ISBN : 9780935184778
Language : En, Es, Fr & De

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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.

Assurance of Sterility for Sensitive Combination Products and Materials

Assurance of Sterility for Sensitive Combination Products and Materials Book
Author : Byron Lambert,Stan Lam,Joyce Hansen,Trabue D. Bryans
Publisher : Academic Press
Release : 2019-06-15
ISBN : 0128050829
Language : En, Es, Fr & De

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Book Description :

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

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes Book
Author : James P. Agalloco,Frederick J. Carleton
Publisher : CRC Press
Release : 2007-09-25
ISBN : 9781420019797
Language : En, Es, Fr & De

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Book Description :

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare Book
Author : Tim Sandle
Publisher : Academic Press
Release : 2018-11-30
ISBN : 0128149124
Language : En, Es, Fr & De

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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. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Handbook of Hygiene Control in the Food Industry

Handbook of Hygiene Control in the Food Industry Book
Author : H. L. M. Lelieveld,John Holah,Domagoj Gabric
Publisher : Woodhead Publishing
Release : 2016-06-10
ISBN : 0081001975
Language : En, Es, Fr & De

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Book Description :

Handbook of Hygiene Control in the Food Industry, Second Edition, continues to be an authoritative reference for anyone who needs hands-on practical information to improve best practices in food safety and quality. The book is written by leaders in the field who understand the complex issues of control surrounding food industry design, operations, and processes, contamination management methods, route analysis processing, allergenic residues, pest management, and more. Professionals and students will find a comprehensive account of risk analysis and management solutions they can use to minimize risks and hazards plus tactics and best practices for creating a safe food supply, farm to fork. Presents the latest research and development in the field of hygiene, offering a broad range of the microbiological risks associated with food processing Provides practical hygiene related solutions in food facilities to minimize foodborne pathogens and decrease the occurrence of foodborne disease Includes the latest information on biofilm formation and detection for prevention and control of pathogens as well as pathogen resistance

ESR Spectroscopy for Life Science Applications An Introduction

ESR Spectroscopy for Life Science Applications  An Introduction Book
Author : Ashutosh Kumar Shukla
Publisher : Springer Nature
Release : 2021-04-20
ISBN : 3030641988
Language : En, Es, Fr & De

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Book Description :

This installment in the Techniques in Life Science and Biomedicine for the Non-Expert series aims to describe ESR spectroscopy as a tool for different applications, such as Healthcare & Pharmaceutical Science, Paleontology & Geochronology and Food Science. In keeping with the series theme, this text is presented in such a manner that the amateur researcher or graduate student can absorb it, while highlighting recent advances and applications of the field. Chapters include solved examples and questions to reinforce themes and encourage readers to apply what they've learnt. ‚Äč

Advanced Aseptic Processing Technology

Advanced Aseptic Processing Technology Book
Author : James Agalloco,James Akers
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1439825440
Language : En, Es, Fr & De

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Book Description :

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on: The use of isolator and barrier concepts for aseptic processing and assembly. The application of robotics as an alternative to gowned personnel. The increasing reliance on automation to minimize or eliminate operator intervention. The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing. Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based Ambulatory care Medical Surgical and Dental Facilities

Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based  Ambulatory care Medical  Surgical  and Dental Facilities Book
Author : Anonim
Publisher : Unknown
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Steam Sterilization and Sterility Assurance Using Table top Sterilizers in Office based Ambulatory care Medical Surgical and Dental Facilities book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

British Pharmaceutical Codex

British Pharmaceutical Codex Book
Author : Anonim
Publisher : Unknown
Release : 1994
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download British Pharmaceutical Codex book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Sterile Drug Products

Sterile Drug Products Book
Author : Michael J. Akers
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420020560
Language : En, Es, Fr & De

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Book Description :

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 book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation Book
Author : E. Clyde Buchanan
Publisher : Amer Soc of Health System
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Principles of Sterile Product Preparation book written by E. Clyde Buchanan, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Introduction to Sterilization and Disinfection

Introduction to Sterilization and Disinfection Book
Author : Joan F. Gardner,Margaret M. Peel
Publisher : Unknown
Release : 1986
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Introduction to Sterilization and Disinfection book written by Joan F. Gardner,Margaret M. Peel, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

USP35 NF30 2012

USP35 NF30  2012 Book
Author : United States Pharmacopeial Convention
Publisher : U.S. Pharmacopeia
Release : 2011-11
ISBN : 9781936424009
Language : En, Es, Fr & De

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Book Description :

The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).

USP DI

USP DI Book
Author : Anonim
Publisher : Physician's Desk Reference (PDR)
Release : 2005
ISBN : 9781563635168
Language : En, Es, Fr & De

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Book Description :

Download USP DI book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Industrial Sterilization

Industrial Sterilization Book
Author : G. Briggs Phillips,William S. Miller
Publisher : B-D Technical
Release : 1973
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Industrial Sterilization book written by G. Briggs Phillips,William S. Miller, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.