Download or read book Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms written by Zhonglin Xu and published by Springer Science & Business Media. This book was released on 2013-10-10 with total page 871 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Clean Room Technology written by James W. Useller and published by . This book was released on 1969 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book GB GB T GBT Product Catalog Translated English of Chinese Standard All national standards GB GB T GBT GBZ written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 2809 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB; GB/T, GBT.

Download or read book Chinese Standard GB GB T GBT JB JB T YY HJ NB HG QC SL SN SH JJF JJG CJ TB YD YS NY FZ JG QB SJ SY DL AQ CB GY JC JR JT written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 7263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).

Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Download or read book Environmental Monitoring for Cleanrooms and Controlled Environments written by Anne Marie Dixon and published by CRC Press. This book was released on 2016-04-19 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Introduction to Contamination Control and Cleanroom Technology written by Matts Ramstorp and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. This book covers the basic principles of contamination control and cleanroom technology from a holistic point of view. It deals with cleanliness and hygiene and their effects on the outcome of a process, reflecting the latest results from both scientific and practical points of view. The following topics are covered: contaminants and how they are measured cleanrooms and clean zones cleaning and decontamination cleanroom clothing the impact of people on cleanliness. Intended as an introduction to the area of contamination control, the text is also an excellent source of knowledge for people with both theoretical and practical experience. The Swedish version has been used for a long time within the Nordic countries as a basic training textbook within the pharmaceutical, microelectronics, food and beverage, optics and many other industries.

Download or read book Microbial Limit and Bioburden Tests written by Lucia Clontz and published by CRC Press. This book was released on 2008-10-14 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c

Download or read book Quality written by Kathleen E. McCormick and published by Butterworth-Heinemann. This book was released on 2022-07-14 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. - Fully revised, updated, and expanded new edition - Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools - Includes end-of-chapter summaries and end-of-chapter question and/or problems - Provides detailed steps and examples for applying the guidelines and quality tools - Written in an accessible style making the content easy to understand and apply

Download or read book Decontamination in Hospitals and Healthcare written by James T. Walker and published by Woodhead Publishing. This book was released on 2019-11-26 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decontamination in Hospitals and Healthcare, Second Edition, enables users to obtain detailed knowledge of decontamination practices in healthcare settings, including surfaces, devices, clothing and people, with a specific focus on hospitals and dental clinics. - Offers in-depth coverage of all aspects of decontamination in healthcare - Examines the decontamination of surgical equipment and endoscopes - Expanded to include new information on behavioral principles in decontamination, control of microbiological problems, waterborne microorganisms, pseudomonas and the decontamination of laundry

Download or read book GB T GBT Product Catalog Translated English of Chinese Standard GB T GBT written by https://www.chinesestandard.net and published by https://www.chinesestandard.net. This book was released on 2018-01-01 with total page 2263 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document provides the comprehensive list of Chinese National Standards - Category: GB/T; GBT.

Download or read book Cleanrooms and Associated Controlled Environments Classification of Air Cleanliness by Particle Concentration written by British Standards Institute Staff and published by . This book was released on 1916-01-31 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clean rooms, Environmental cleanliness, Classification systems, Particulate air pollutants, Particle size distribution, Designations, Concentration, Conformity, Test equipment, Sample location, Sampling methods, Samples, Outliers, Statistical methods of analysis, Algorithms, Mathematical calculations, Sequential sampling

Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by ASHP. This book was released on 2009-02-01 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.

Download or read book Cleanroom Technology written by William Whyte and published by John Wiley & Sons. This book was released on 2010-03-01 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

Download or read book The ASQ Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2024-09-30 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Cleanrooms and Associated Controlled Environments Classification of Air Cleanliness by Chemical Concentration ACC written by British Standards Institute Staff and published by . This book was released on 1913-02-28 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clean rooms, Environmental cleanliness, Environment (working), Classification systems, Molecules, Contamination, Air pollution, Air, Designations, Concentration, Verification, Chemical analysis and testing, Test equipment, Sampling methods