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Biocontamination Control For Pharmaceuticals And Healthcare

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Biocontamination Control for Pharmaceutical and Healthcare

Biocontamination Control for Pharmaceutical and Healthcare Book
Author : Tim Sandle
Publisher : Academic Press
Release : 2019-01-15
ISBN : 9780128149119
Language : En, Es, Fr & De

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Book Description :

Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that tracks through a facility with bio-burden control and reduction at each transition in classified areas; this is a key part of controlling risk escalation to contaminating medicinal products. Regulatory authorities have challenged pharmaceutical and healthcare sectors, and those involved in Good Manufacturing Practice (GMP), to adopt a holistic approach to contamination control. Established ways of assessing contamination are limited, and therefore risk-based approaches are required. As well as using risk to assess types of contamination and where contamination can arise, 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 an up to date and complete biocontamination strategy. Provides the information for a facility to build a complete biocontamination strategy Allows a facility to understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements and reducing process risks Provides insight into developing an environmental monitoring programme Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

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

Aulton s Pharmaceutics E Book

Aulton s Pharmaceutics E Book Book
Author : Kevin M.G. Taylor,Michael E. Aulton
Publisher : Elsevier Health Sciences
Release : 2021-04-23
ISBN : 0702081566
Language : En, Es, Fr & De

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Book Description :

The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation Designed and written for newcomers to the design and manufacture of dosage forms Relevant pharmaceutical science covered throughout Includes the science of formulation and drug delivery Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines Key points boxes throughout Over 400 online multiple choice questions

An Industrial IoT Approach for Pharmaceutical Industry Growth

An Industrial IoT Approach for Pharmaceutical Industry Growth Book
Author : Valentina E. Balas,Vijender Kumar Solanki,Raghvendra Kumar
Publisher : Academic Press
Release : 2020-05-15
ISBN : 0128213272
Language : En, Es, Fr & De

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Book Description :

An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing

Cannabis Laboratory Fundamentals

Cannabis Laboratory Fundamentals Book
Author : Shaun R. Opie
Publisher : Springer Nature
Release : 2021-03-09
ISBN : 3030627160
Language : En, Es, Fr & De

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Book Description :

The legislative requirement for cannabis to undergo laboratory testing has followed legalization of medical and recreational use in every U.S. state to date. Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space. However, many of the costs, timelines, operational requirements, and compliance issues are overlooked by people who have not been exposed to regulated laboratory testing. Cannabis Laboratory Fundamentals provides an in-depth review of the key issues that impact cannabis testing laboratories and provides recommendations and solutions to avoid common – but expensive – mistakes. The text goes beyond methodology to include sections on economics, regulation, and operational challenges, making it useful for both new and experienced cannabis laboratory operators, as well as all those who want to understand the opportunities and risks of this industry.

Bio Contamination

Bio Contamination Book
Author : Anonim
Publisher : Unknown
Release : 2014
ISBN : 9781905271245
Language : En, Es, Fr & De

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Book Description :

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

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

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control Book
Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Release : 2020-01-02
ISBN : 1119356075
Language : En, Es, Fr & De

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Book Description :

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

Healthcare Sterilisation

Healthcare Sterilisation Book
Author : Wayne J Rogers
Publisher : Smithers Rapra
Release : 2014-06-09
ISBN : 1909030708
Language : En, Es, Fr & De

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Book Description :

The collection of topics in the second volume of this book challenges the reader to think beyond standard methods and question why certain current procedures remain static while technological advances abound in other aspects of sterilisation technology. By small means, better practices may come to pass to help answer some of the residual healthcare sterilisation and nosocomial infection queries: What are some of the current challenges in healthcare sterilisation, and how can they be handled? What are some of the acceptable current non-traditional sterilisation methods, challenging alternatives, and novel modalities? What are some of the packaging, validation and statistical considerations of sterilisation practices? How does design-of-product and packaging interrelate with sterilisation processing? Are the current sterility media and practices optimal for recovery of more modified and more resistant viable organism entities and product? Are there increased sterility and product quality needs with new types of implantables and technological advances within the three dimensional combinations of diagnostics, drug release and challenging medical devices?

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

Clean Room Technology in ART Clinics

Clean Room Technology in ART Clinics Book
Author : Sandro C. Esteves,Alex C. Varghese,Kathryn C. Worrilow
Publisher : CRC Press
Release : 2016-11-18
ISBN : 1482254085
Language : En, Es, Fr & De

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Book Description :

Regulatory agencies worldwide have issued directives or such requirements for air quality standards in embryology laboratories. This practical guide reviews the application of clean room technology or controlled environments specifically suited for Assisted Reproductive Technology (ART) Units. Its comprehensive coverage includes material on airborne particles and volatile organic compounds, including basic concepts, regulation, construction, materials, certification, clinical results in humans, and more.

Sterilisation of Polymer Healthcare Products

Sterilisation of Polymer Healthcare Products Book
Author : Wayne Rogers
Publisher : iSmithers Rapra Publishing
Release : 2005
ISBN : 9781859574904
Language : En, Es, Fr & De

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Book Description :

Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.

Ayliffe s Control of Healthcare Associated Infection Fifth Edition

Ayliffe s Control of Healthcare Associated Infection Fifth Edition Book
Author : Adam Fraise,Christina Bradley
Publisher : CRC Press
Release : 2009-05-29
ISBN : 0340914513
Language : En, Es, Fr & De

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Book Description :

The fifth edition of this classic text is the definitive, clinically orientated guide to a critical area within healthcare practice, full of sound, practical advice for all those involved in the control of infection in a variety of settings. Known in previous editions as Control of Hospital Infection, the new Ayliffe's Control of Healthcare-Associated Infection has again been brought up to date and thoroughly revised to emphasise the broader range of its coverage, from the hospital setting - including the ward, operating theatres, kitchens and laundry facilities - to health care provision in the community. Returning readers will find that the content has also been restructured, improving access to related topics. Part One discusses the basic principles of infection control, including administrative issues, surveillance and reporting, sterilization, disinfection and decontamination, with an emphasis on the key area of hand hygiene. Part Two covers the specific areas of prophylaxis and treatment of infections. In Part Three prevention in different healthcare settings is presented, including issues particular to special wards and departments such as paediatric and neonatal units, intensive care, the elderly and those being treated or working within allied health areas such as x-ray, physiotherapy and the laboratory setting. Ayliffe's Control of Healthcare-Associated Infection remains essential reading for all infection control practitioners, nurses, doctors, surgeons, allied health professionals, hospital managers and administrators, and public health personnel.

Control of Particulate Matter Contamination in Healthcare Manufacturing

Control of Particulate Matter Contamination in Healthcare Manufacturing Book
Author : Thomas A. Barber
Publisher : CRC Press
Release : 1999-10-31
ISBN : 1000065111
Language : En, Es, Fr & De

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Book Description :

This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding of particle populations and their control in stabi

Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II Book
Author : Michael J. Groves,Ram Murty
Publisher : CRC Press
Release : 2020-08-14
ISBN : 1000122972
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.

Buildings for Advanced Technology

Buildings for Advanced Technology Book
Author : Ahmad Soueid,E. Clayton Teague,James Murday
Publisher : Springer
Release : 2015-12-30
ISBN : 3319248928
Language : En, Es, Fr & De

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Book Description :

This book deals with the design and construction of buildings for nanoscale science and engineering research. The information provided in this book is useful for designing and constructing buildings for such advanced technologies as nanotechnology, nanoelectronics and biotechnology. The book outlines the technology challenges unique to each of the building environmental challenges outlined below and provides best practices and examples of engineering approaches to address them: • Establishing and maintaining critical environments: temperature, humidity, and pressure • Structural vibration isolation • Airborne vibration isolation (acoustic noise) • Isolation of mechanical equipment-generated vibration/acoustic noise • Cost-effective power conditioning • Grounding facilities for low electrical interference • Electromagnetic interference (EMI)/Radio frequency interference (RFI) isolation • Airborne particulate contamination • Airborne organic and chemical contamination • Environment, safety and health (ESH) considerations • Flexibility strategies for nanotechnology facilities The authors are specialists and experts with knowledge and experience in the control of environmental disturbances to buildings and experimental apparatus.

In Vitro Fertilization

In Vitro Fertilization Book
Author : Zsolt Peter Nagy,Alex C. Varghese,Ashok Agarwal
Publisher : Springer
Release : 2019-07-03
ISBN : 3319430114
Language : En, Es, Fr & De

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Book Description :

Now in its revised and expanded second edition - including over 20 new chapters - this comprehensive textbook remains a unique and accessible description of the current and developing diagnostic and treatment techniques and technologies comprising in vitro fertilization (IVF). Arranged thematically in sections, each chapter covers a key topic in IVF in a sensible presentation. Parts one and two describe the planning, design and organization of an ART unit and IVF laboratory and equipment and systems, respectively. The sections that follow provide detailed descriptions of IVF techniques, embryo culture methods, sperm processing and selection, insemination procedures, micromanipulation, embryo evaluation, cryopreservation, and embryo transfer. Concluding sections address issues of management and regulation of ART labs across the globe, as well as special topics and emerging techniques and devices. Chapter authors, all experts in the field, contribute their expertise from around the world. With the addition of learning key points and review questions at the beginning and end of each chapter, this new edition of In Vitro Fertilization is a readily accessible, high quality instructional resource for reproductive medicine trainees at all levels. Practicing reproductive endocrinologists, urologists, and embryologists also will find value in the book, as will infertility researchers.

Practical Manual of In Vitro Fertilization

Practical Manual of In Vitro Fertilization Book
Author : Zsolt Peter Nagy,Alex C. Varghese,Ashok Agarwal
Publisher : Springer Science & Business Media
Release : 2012-04-23
ISBN : 1441917802
Language : En, Es, Fr & De

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Book Description :

The Practical Manual of In Vitro Fertilization: Advanced Methods and Novel Devices is a unique, accessible title that provides a complete review of the most well-established and current diagnostic and treatment techniques comprising in vitro fertilization. Throughout the chapters, a uniform structure is employed, including a brief abstract, a keyword glossary, a step-by-step protocol of the laboratory procedures, several pages of expert commentary, key issues of clinical concern, and a list of references. The result is a readily accessible, high quality reference guide for reproductive endocrinologists, urologists, embryologists, biologists and research scientists. The Manual also offers an excellent description of novel procedures that will likely be employed in the near future. An indispensable resource for physicians and basic scientists, the Practical Manual of In Vitro Fertilization: Advanced Methods and Novel Devices is an invaluable reference and addition to the literature.

Pharmacology of Ocular Therapeutics

Pharmacology of Ocular Therapeutics Book
Author : Thirumurthy Velpandian
Publisher : Springer
Release : 2016-02-29
ISBN : 3319254987
Language : En, Es, Fr & De

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Book Description :

This book comprises an integrated review of ocular therapeutics across all relevant fields. It addresses the real-world requirements of ophthalmologists, pharmacists and optometrists, as observed through working alongside these practitioners for two decades. Knowledge surrounding agents used in ophthalmic practice has, historically, been scattered. The book facilitates understanding of ocular drug therapy by compiling all key aspects of the pharmacology, toxicology, pharmaceutical science, ocular biochemistry and cell biology of these agents. Chapters detail drug transfer across barriers, systemic toxicity of topically applied drugs, autonomic drugs used for diagnostics, as well as anti-inflammatory, antiallergic, glaucoma and antimicrobial therapies, and avenues for the development of new ocular drugs. Applications of extemporaneously prepared formulations are described to inform day-to-day clinical practice. The use of mucoadhesive polymers in tear substitutes, ocular drug delivery systems, stem cell therapy, pharmacogenomics and antiangiogenic ocular chemotherapy are also explored. The book also provides insights from drugs of herbal origin, and a historical perspective on drugs for ocular use. Practicing and resident ophthalmologists, optometrists, pharmacists, nursing professionals, scholars in ocular drug research and students will equally benefit from this comprehensive guide.

Antisepsis Disinfection and Sterilization

Antisepsis  Disinfection  and Sterilization Book
Author : Gerald E. McDonnell
Publisher : John Wiley & Sons
Release : 2020-07-10
ISBN : 1555819680
Language : En, Es, Fr & De

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Book Description :

Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of the methods are thoroughly and clearly presented. Sufficient background on the life cycles and general anatomy of microorganisms is provided so that the reader who is new to microbiology will better appreciate how physical and chemical biocides work their magic on microbes. Other topics in the book include: Evaluating the efficacy of chemical antiseptics and disinfectants, and of physical methods of microbial control and sterilization. Understanding how to choose the proper biocidal product and process for specific applications. Classic physical and chemical disinfection methods, such as heat, cold, non-ionizing radiation, acids, oxidizing agents, and metals. Newer chemical disinfectants, including, isothiazolones, micro-and nano-particles, and bacteriophages as control agents. Antisepsis of skin and wounds and the biocides that can be used as antiseptics. Classic methods of physical sterilization, such as, moist heat and dry heat sterilization, ionizing radiation, and filtration, along with newer methods, including, the use of plasma or pulsed light. Chemical sterilization methods that use ethylene oxide, formaldehyde, or a variety of other oxidizing agents. A detailed look at the modes of action of biocides in controlling microbial growth and disrupting microbial physiology. Mechanisms that microorganisms use to resist the effects of biocides. The second edition of Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance is well suited as a textbook and is outstanding as a reference book for facilities managers and application engineers in manufacturing plants, hospitals, and food production facilities. It is also essential for public health officials, healthcare professionals, and infection control practitioners.