biocontamination control for pharmaceuticals and healthcare

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Biocontamination Control for Pharmaceutical and Healthcare
Author : Tim Sandle
Publisher : Academic Press
Release Date : 2019-01-15
ISBN 10 : 9780128149119
Pages : 250 pages
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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
Author : Tim Sandle
Publisher : Academic Press
Release Date : 2018-11-30
ISBN 10 : 0128149124
Pages : 374 pages
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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

Pharmaceutical Microbiology
Author : Tim Sandle
Publisher : Woodhead Publishing
Release Date : 2015-10-09
ISBN 10 : 0081000448
Pages : 316 pages
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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

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms
Author : Dr. Tim Sandle
Publisher : Grosvenor House Publishing
Release Date : 2012-08-02
ISBN 10 : 178148080X
Pages : 300 pages
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The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.

Pharmaceutical Microbiological Quality Assurance and Control
Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Release Date : 2020-01-02
ISBN 10 : 1119356075
Pages : 592 pages
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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

Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals
Author : Tim Sandle
Publisher : Elsevier
Release Date : 2013-10-31
ISBN 10 : 1908818638
Pages : 362 pages
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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

Biopharmaceutical Processing
Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
Publisher : Elsevier
Release Date : 2018-01-18
ISBN 10 : 0128125527
Pages : 1308 pages
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Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Pharmaceutical Microbiology
Author : Tim Sandle
Publisher : Woodhead Publishing
Release Date : 2015-10-09
ISBN 10 : 0081000448
Pages : 316 pages
GET BOOK!

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

WHO Guidelines for Indoor Air Quality
Author : World Health Organization
Publisher : WHO Regional Office Europe
Release Date : 2009
ISBN 10 : 9289041684
Pages : 228 pages
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Microbial pollution is a key element of indoor air pollution. It is caused by hundreds of species of bacteria and fungi, in particular filamentous fungi (mould), growing indoors when sufficient moisture is available. This document provides a comprehensive review of the scientific evidence on health problems associated with building moisture and biological agents. The review concludes that the most important effects are increased prevalences of respiratory symptoms, allergies and asthma as well as perturbation of the immunological system. The document also summarizes the available information on the conditions that determine the presence of mould and measures to control their growth indoors. WHO guidelines for protecting public health are formulated on the basis of the review. The most important means for avoiding adverse health effects is the prevention (or minimization) of persistent dampness and microbial growth on interior surfaces and in building structures. [Ed.]

Safe Management of Wastes from Health-care Activities
Author : World Health Organization
Publisher : World Health Organization
Release Date : 2014
ISBN 10 : 9241548568
Pages : 308 pages
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This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Release Date : 2003-09-02
ISBN 10 : 9780203305195
Pages : 280 pages
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Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

Healthcare Sterilisation
Author : Wayne J Rogers
Publisher : Smithers Rapra
Release Date : 2014-06-09
ISBN 10 : 1909030708
Pages : 540 pages
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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?

Pharmaceutical Microbiological Quality Assurance and Control
Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Release Date : 2019-12-02
ISBN 10 : 1119356121
Pages : 592 pages
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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

Pharmaceutical Manufacturing Handbook
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release Date : 2008-03-21
ISBN 10 : 0470259809
Pages : 1384 pages
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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.

Control of Particulate Matter Contamination in Healthcare Manufacturing
Author : Thomas A. Barber
Publisher : CRC Press
Release Date : 1999-10-31
ISBN 10 : 9781574910728
Pages : 574 pages
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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 stability, efficacy, and predictability in the manufacture of healthcare products. Complete with a full-color insert of micrographs illustrating commonly encountered particulate matter and over eighty figures, tables, and charts. Features

Microbiological Culture Media
Author : Tim Sandle
Publisher : N.A
Release Date : 2018
ISBN 10 : 9781942911159
Pages : 570 pages
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Pharmaceutical Facilities
Author : Manohar A Potdar
Publisher : N.A
Release Date : 2014-11
ISBN 10 : 9789385433764
Pages : 306 pages
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Designing, erection and commissioning of a pharmaceutical plant is a long drawn process. It needs basic understanding of pharmaceutical formulations and their logical and sequential processing. This whole process is tedious, time consuming and should have proper guidance in this regard. The book will provide such guidance which is a long felt need by the industry. Salient Features: - Pharmaceutical design aspects with sample layouts for all major formulations are discussed - All aspects related to project management, regulatory requirements, validation of facilities, HVAC and water system are discussed - A real handy book for all those who are involved in plant design, project management and facility and utilities validation in Pharmaceutical industry.

Risk Management and Risk Assessment for Pharmaceutical Manufacturing
Author : Dr Tim Sandle
Publisher : Createspace Independent Publishing Platform
Release Date : 2013-06-01
ISBN 10 : 9781482596144
Pages : 168 pages
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This book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.

Biosensing Technologies for the Detection of Pathogens
Author : Toonika Rinken,Kairi Kivirand
Publisher : BoD – Books on Demand
Release Date : 2018-03-21
ISBN 10 : 9535139150
Pages : 216 pages
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Rapid multiplex detection of pathogens in the environment and in our food is a key factor for the prevention and effective treatment of infectious diseases. Biosensing technologies combining the high selectivity of biomolecular recognition and the sensitivity of modern signal detection platforms are a prospective option for automated analyses. They allow rapid detection of single molecules as well as cellular substances. This book, including 12 chapters from 50 authors, introduces the principles of identification of specific pathogen biomarkers along with different biosensor-based technologies applied for pathogen detection.

Sterile Filtration
Author : Maik W. Jornitz
Publisher : CRC Press
Release Date : 2020-04-15
ISBN 10 : 1000083233
Pages : 640 pages
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This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!