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Author: British Standards Institute Staff
Publisher:
Published: 1916-01-31
Total Pages: 26
ISBN-13: 9780580573019
DOWNLOAD EBOOK →Clean rooms, Environmental cleanliness, Air cleaning equipment, Decontamination, Conformity, Classification systems
Author: Tim Sandle
Publisher: Elsevier
Published: 2024-02-09
Total Pages: 510
ISBN-13: 0443216010
DOWNLOAD EBOOK →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
Author: British Standards Institute Staff
Publisher:
Published: 1918-09-06
Total Pages: 20
ISBN-13: 9780580957611
DOWNLOAD EBOOK →Environmental cleanliness, Maintenance, Cleaning, Clean rooms, Leak tests, Instructions for use, Environment (working), Air cleaning equipment, Waste handling, Design, Qualification approval, Air treatment devices, Access, Performance testing, Classification systems, Contamination, Air-distribution systems, Rooms, Installation, Communicable disease control
Author: Mark Allen Durivage
Publisher: Quality Press
Published: 2016-05-26
Total Pages: 386
ISBN-13: 0873899334
DOWNLOAD EBOOK →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.
Author: James T. Walker
Publisher: Woodhead Publishing
Published: 2019-11-26
Total Pages: 594
ISBN-13: 0081025661
DOWNLOAD EBOOK →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
Author: Kathleen E. McCormick
Publisher: Butterworth-Heinemann
Published: 2022-07-14
Total Pages: 385
ISBN-13: 0323994601
DOWNLOAD EBOOK →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
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
Published: 2022-06-02
Total Pages: 272
ISBN-13:
DOWNLOAD EBOOK →This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2021.
Author: Carla Viegas
Publisher: Springer
Published: 2017-10-05
Total Pages: 413
ISBN-13: 3319616889
DOWNLOAD EBOOK →This book intends to provide information about detection and health effects due to bacteria, fungi and viruses in indoor environments. The book will cover also information about preventive and protective measures to avoid health-hazardous. Case studies will be also addressed to enrich the book with the expertise of each invited author. The book also intends to fill a gap regarding information about all biologic agents, since most of the books available are dedicated to only one type of microorganisms. For various different biologic agents and metabolites this book will compile information about indoors presence, detection methods, exposure assessment and health effects. Several problems regarding the exposure of biologic agents will be presented through case studies, and also the implementation of preventive and protective measures to avoid/minimize exposure. Besides, all the book will focus on occupational health and/or public health point of view.
Author: Mary T. am Ende
Publisher: John Wiley & Sons
Published: 2019-04-08
Total Pages: 1435
ISBN-13: 111928550X
DOWNLOAD EBOOK →A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
