Environmental Monitoring for Cleanrooms and Controlled Environments

Environmental Monitoring for Cleanrooms and Controlled Environments
Author: Anne Marie Dixon
Publisher: CRC Press
Total Pages: 254
Release: 2016-04-19
Genre: Medical
ISBN: 1420014854

A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
Author: Tim Sandle
Publisher: Elsevier
Total Pages: 510
Release: 2024-01-28
Genre: Medical
ISBN: 0443216010

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. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti
Publisher: John Wiley & Sons
Total Pages: 594
Release: 2020-01-02
Genre: Technology & Engineering
ISBN: 1119356075

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

Aquatic Ecotoxicology

Aquatic Ecotoxicology
Author: Claude Amiard-Triquet
Publisher: Academic Press
Total Pages: 519
Release: 2015-06-11
Genre: Science
ISBN: 0128011769

Aquatic Ecotoxicology: Advancing Tools for Dealing with Emerging Risks presents a thorough look at recent advances in aquatic ecotoxicology and their application in assessing the risk of well-known and emerging environmental contaminants. This essential reference, brought together by leading experts in the field, guides users through existing and novel approaches to environmental risk assessment, then presenting recent advances in the field of ecotoxicology, including omics-based technologies, biomarkers, and reference species. The book then demonstrates how these advances can be used to design and perform assays to discover the toxicological endpoints of emerging risks within the aquatic environment, such as nanomaterials, personal care products, PFOS and chemical mixtures. The text is an invaluable reference for any scientist who studies the effects of contaminants on organisms that live within aquatic environments. - Provides the latest perspectives on emerging toxic risks to aquatic environments, such as nanomaterials, pharmaceuticals, chemical mixtures, and perfluorooctane sulfonate (PFOS) - Offers practical guidance on recent advances to help in choosing the most appropriate toxicological assay - Presents case studies and information on a variety of reference species to help put the ecotoxicological theory into practical risk assess

Cleanroom Technology

Cleanroom Technology
Author: William Whyte
Publisher: John Wiley & Sons
Total Pages: 382
Release: 2010-03-01
Genre: Technology & Engineering
ISBN: 0470748060

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 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
Publisher: Grosvenor House Publishing
Total Pages: 284
Release: 2012-08-02
Genre: Health & Fitness
ISBN: 178148080X

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.

Surface Engineered Surgical Tools and Medical Devices

Surface Engineered Surgical Tools and Medical Devices
Author: Mark J. Jackson
Publisher: Springer Science & Business Media
Total Pages: 595
Release: 2007-08-03
Genre: Technology & Engineering
ISBN: 0387270280

This book examines the interaction between nano tools and nano materials. It explains the use of appropriate tools in surgery for a variety of applications and provides a complete description of clinical procedures accompanied by photographs. Coverage also presents the latest developments in surface coatings technology such as chemical vapor deposition for use on complex cutting tools for biomedical applications.

CleanRooms

CleanRooms
Author:
Publisher:
Total Pages: 48
Release: 2008-04
Genre:
ISBN:

A central resource of technology and methods for environments where the control of contamination is critical.

Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms

Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms
Author: Zhonglin Xu
Publisher: Springer Science & Business Media
Total Pages: 871
Release: 2013-10-10
Genre: Technology & Engineering
ISBN: 3642393748

Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms sets up the theoretical framework for cleanrooms. New ideas and methods are presented, which include the characteristic index of cleanrooms, uniform and non-uniform distribution characteristics, the minimum sampling volume, a new concept of outdoor air conditioning and the fundamentals of leakage-preventing layers. Written by an author who can look back on major scientific achievements and 50 years of experience in this field, this book offers a concise and accessible introduction to the fundamentals of air cleaning technology and its application. The work is intended for researchers, college teachers, graduates, designers, technicians and corporate R&D personnel in the field of HVAC and air cleaning technology. Zhonglin Xu is a senior research fellow at China Academy of Building Research.

Data Center Handbook

Data Center Handbook
Author: Hwaiyu Geng
Publisher: John Wiley & Sons
Total Pages: 720
Release: 2014-12-22
Genre: Computers
ISBN: 1118436636

Provides the fundamentals, technologies, and best practices in designing, constructing and managing mission critical, energy efficient data centers Organizations in need of high-speed connectivity and nonstop systems operations depend upon data centers for a range of deployment solutions. A data center is a facility used to house computer systems and associated components, such as telecommunications and storage systems. It generally includes multiple power sources, redundant data communications connections, environmental controls (e.g., air conditioning, fire suppression) and security devices. With contributions from an international list of experts, The Data Center Handbook instructs readers to: Prepare strategic plan that includes location plan, site selection, roadmap and capacity planning Design and build "green" data centers, with mission critical and energy-efficient infrastructure Apply best practices to reduce energy consumption and carbon emissions Apply IT technologies such as cloud and virtualization Manage data centers in order to sustain operations with minimum costs Prepare and practice disaster reovery and business continuity plan The book imparts essential knowledge needed to implement data center design and construction, apply IT technologies, and continually improve data center operations.