Biocontamination Control for Pharmaceutical and Healthcare

Biocontamination Control for Pharmaceutical and Healthcare
Author: Tim Sandle
Publsiher: Academic Press
Total Pages: 250
Release: 2019-01-15
ISBN 10: 9780128149119
ISBN 13: 0128149116
Language: EN, FR, DE, ES & NL

Biocontamination Control for Pharmaceutical and Healthcare Book Review:

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
Author: Tim Sandle
Publsiher: Academic Press
Total Pages: 374
Release: 2018-11-30
ISBN 10: 0128149124
ISBN 13: 9780128149126
Language: EN, FR, DE, ES & NL

Biocontamination Control for Pharmaceuticals and Healthcare Book Review:

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

Pharmaceutical Microbiology
Author: Tim Sandle
Publsiher: Woodhead Publishing
Total Pages: 316
Release: 2015-10-09
ISBN 10: 0081000448
ISBN 13: 9780081000441
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Book Review:

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

The CDC Handbook   A Guide to Cleaning and Disinfecting Clean Rooms
Author: Dr. Tim Sandle
Publsiher: Grosvenor House Publishing
Total Pages: 300
Release: 2012-08-02
ISBN 10: 178148080X
ISBN 13: 9781781480809
Language: EN, FR, DE, ES & NL

The CDC Handbook A Guide to Cleaning and Disinfecting Clean Rooms Book Review:

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.

Risk Management and Risk Assessment for Pharmaceutical Manufacturing

Risk Management and Risk Assessment for Pharmaceutical Manufacturing
Author: Dr Tim Sandle
Publsiher: Createspace Independent Publishing Platform
Total Pages: 168
Release: 2013-06-01
ISBN 10: 9781482596144
ISBN 13: 1482596148
Language: EN, FR, DE, ES & NL

Risk Management and Risk Assessment for Pharmaceutical Manufacturing Book Review:

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.

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
Author: Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publsiher: CRC Press
Total Pages: 280
Release: 2003-09-02
ISBN 10: 9780203305195
ISBN 13: 0203305191
Language: EN, FR, DE, ES & NL

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Book Review:

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.

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
Author: Tim Sandle
Publsiher: Elsevier
Total Pages: 362
Release: 2013-10-31
ISBN 10: 1908818638
ISBN 13: 9781908818638
Language: EN, FR, DE, ES & NL

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals Book Review:

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

Pharmaceutical Microbiology

Pharmaceutical Microbiology
Author: Tim Sandle
Publsiher: Woodhead Publishing
Total Pages: 316
Release: 2015-10-09
ISBN 10: 0081000448
ISBN 13: 9780081000441
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiology Book Review:

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

Healthcare Sterilisation

Healthcare Sterilisation
Author: Wayne J Rogers
Publsiher: Smithers Rapra
Total Pages: 540
Release: 2014-06-09
ISBN 10: 1909030708
ISBN 13: 9781909030701
Language: EN, FR, DE, ES & NL

Healthcare Sterilisation Book Review:

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?

WHO Guidelines for Indoor Air Quality

WHO Guidelines for Indoor Air Quality
Author: World Health Organization
Publsiher: WHO Regional Office Europe
Total Pages: 228
Release: 2009
ISBN 10: 9289041684
ISBN 13: 9789289041683
Language: EN, FR, DE, ES & NL

WHO Guidelines for Indoor Air Quality Book Review:

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.]

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 592
Release: 2020-01-02
ISBN 10: 1119356075
ISBN 13: 9781119356073
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiological Quality Assurance and Control Book Review:

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 Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 592
Release: 2019-12-02
ISBN 10: 1119356121
ISBN 13: 9781119356127
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiological Quality Assurance and Control Book Review:

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

Control of Particulate Matter Contamination in Healthcare Manufacturing

Control of Particulate Matter Contamination in Healthcare Manufacturing
Author: Thomas A. Barber
Publsiher: CRC Press
Total Pages: 574
Release: 1999-10-31
ISBN 10: 9781574910728
ISBN 13: 1574910728
Language: EN, FR, DE, ES & NL

Control of Particulate Matter Contamination in Healthcare Manufacturing Book Review:

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

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
ISBN 10: 0470259809
ISBN 13: 9780470259801
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

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.

Indoor Air Quality in Healthcare Facilities

Indoor Air Quality in Healthcare Facilities
Author: Stefano Capolongo,Gaetano Settimo,Marco Gola
Publsiher: Springer
Total Pages: 132
Release: 2017-03-21
ISBN 10: 3319491601
ISBN 13: 9783319491608
Language: EN, FR, DE, ES & NL

Indoor Air Quality in Healthcare Facilities Book Review:

This interdisciplinary guide offers background, research findings, and practical strategies for assessing and improving air quality in hospitals and other healthcare settings. Positing good air quality as critical to patient and staff well-being, it identifies disease-carrying microbes, pollutants, and other airborne toxins and their health risks, and provides localized interventions for reducing transmission of pathogens. Effective large-scale approaches to air quality control are also outlined, from green building materials to hygienic HVAC and air treatment practices. Its thoroughness of coverage makes this book a vital resource for professionals involved in every aspect of health service facilities, from planning and construction to maintenance and management. Among the topics covered: Existing guidelines in indoor air quality: the case study of hospital environments Hospital environments and epidemiology of healthcare-associated infections Analysis of microorganisms in hospital environments and potential risks Legionella indoor air contamination in healthcare environments HVAC system design in healthcare facilities and control of aerosol contaminants Assessment of indoor air quality in inpatient wards Indoor Air Quality in Healthcare Facilities imparts up-to-date expertise to a variety of professional readers, including hospitals' technical and management departments, healthcare facilities' chief medical officers, hospital planners, sport and thermal building designers, public health departments, and students of universities and schools of hygiene.

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 9781420019797
ISBN 13: 1420019791
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

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

Cleanroom Technology

Cleanroom Technology
Author: William Whyte
Publsiher: John Wiley & Sons
Total Pages: 384
Release: 2011-08-17
ISBN 10: 1119965594
ISBN 13: 9781119965596
Language: EN, FR, DE, ES & NL

Cleanroom Technology Book Review:

A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination... This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme. Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries. William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology. A comment on the first edition: "...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)

The Performance Economy

The Performance Economy
Author: W. Stahel
Publsiher: Springer
Total Pages: 349
Release: 2010-02-24
ISBN 10: 0230274900
ISBN 13: 9780230274907
Language: EN, FR, DE, ES & NL

The Performance Economy Book Review:

This updated and revised edition outlines strategies and models for how to use technology and knowledge to improve performance, create jobs and increase income. It shows what skills will be required to produce, sell and manage performance over time, and how manual jobs can contribute to reduce the consumption of non-renewable resources.

Microbiological Culture Media

Microbiological Culture Media
Author: Tim Sandle
Publsiher: Unknown
Total Pages: 570
Release: 2018
ISBN 10: 9781942911159
ISBN 13: 1942911157
Language: EN, FR, DE, ES & NL

Microbiological Culture Media Book Review:

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 234
Release: 2019-06-13
ISBN 10: 0128175699
ISBN 13: 9780128175699
Language: EN, FR, DE, ES & NL

Equipment Qualification in the Pharmaceutical Industry Book Review:

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements