Cleanrooms and Associated Controlled Environments. Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle Concentration

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Publisher :
ISBN 13 : 9780580573019
Total Pages : 26 pages
Book Rating : 4.5/5 (73 download)

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Book Synopsis Cleanrooms and Associated Controlled Environments. Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle Concentration by : British Standards Institute Staff

Download or read book Cleanrooms and Associated Controlled Environments. Monitoring to Provide Evidence of Cleanroom Performance Related to 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 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clean rooms, Environmental cleanliness, Air cleaning equipment, Decontamination, Conformity, Classification systems

ISO 14644-2: 2015. Cleanrooms and Associated Controlled Environments

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Publisher :
ISBN 13 :
Total Pages : 14 pages
Book Rating : 4.:/5 (948 download)

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Book Synopsis ISO 14644-2: 2015. Cleanrooms and Associated Controlled Environments by :

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Biocontamination Control for Pharmaceuticals and Healthcare

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Author :
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.4/5 (432 download)

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Book Synopsis Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle

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

Cleanrooms and Associated Controlled Environments. Specifications for Monitoring Air Cleanliness by Nanoscale Particle Concentration

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Publisher :
ISBN 13 : 9780580957611
Total Pages : 20 pages
Book Rating : 4.9/5 (576 download)

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Book Synopsis Cleanrooms and Associated Controlled Environments. Specifications for Monitoring Air Cleanliness by Nanoscale Particle Concentration by : British Standards Institute Staff

Download or read book Cleanrooms and Associated Controlled Environments. Specifications for Monitoring Air Cleanliness by Nanoscale Particle Concentration written by British Standards Institute Staff and published by . This book was released on 1918-09-06 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Decontamination in Hospitals and Healthcare

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Publisher : Woodhead Publishing
ISBN 13 : 0081025661
Total Pages : 594 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Decontamination in Hospitals and Healthcare by : James T. Walker

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

The Certified Pharmaceutical GMP Professional Handbook

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Publisher : Quality Press
ISBN 13 : 1951058909
Total Pages : 404 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis The Certified Pharmaceutical GMP Professional Handbook by : Mark Allen Durivage

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.

Quality

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Author :
Publisher : Butterworth-Heinemann
ISBN 13 : 0323994601
Total Pages : 385 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Quality by : Kathleen E. McCormick

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

The ASQ Certified Pharmaceutical GMP Professional Handbook

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Author :
Publisher : Quality Press
ISBN 13 : 1636941516
Total Pages : 421 pages
Book Rating : 4.6/5 (369 download)

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Book Synopsis The ASQ Certified Pharmaceutical GMP Professional Handbook by : Mark Allen Durivage

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.

Exposure to Microbiological Agents in Indoor and Occupational Environments

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Author :
Publisher : Springer
ISBN 13 : 3319616889
Total Pages : 413 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Exposure to Microbiological Agents in Indoor and Occupational Environments by : Carla Viegas

Download or read book Exposure to Microbiological Agents in Indoor and Occupational Environments written by Carla Viegas and published by Springer. This book was released on 2017-10-05 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

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Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 7290 pages
Book Rating : 4./5 ( download)

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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 7290 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).

GB/T-2021, GB-2021 -- Chinese National Standard PDF-English, Catalog (year 2021)

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Author :
Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 272 pages
Book Rating : 4./5 ( download)

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Book Synopsis GB/T-2021, GB-2021 -- Chinese National Standard PDF-English, Catalog (year 2021) by : https://www.chinesestandard.net

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Chemical Engineering in the Pharmaceutical Industry

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Publisher : John Wiley & Sons
ISBN 13 : 111928550X
Total Pages : 1435 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

GB, GB/T, GBT - Product Catalog. Translated English of Chinese Standard (All national standards GB, GB/T, GBT, GBZ)

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Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 2806 pages
Book Rating : 4./5 ( download)

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Book Synopsis GB, GB/T, GBT - Product Catalog. Translated English of Chinese Standard (All national standards GB, GB/T, GBT, GBZ) by : https://www.chinesestandard.net

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Biopharmaceutical Manufacturing

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Author :
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110617013
Total Pages : 433 pages
Book Rating : 4.1/5 (16 download)

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Book Synopsis Biopharmaceutical Manufacturing by : Gary Gilleskie

Download or read book Biopharmaceutical Manufacturing written by Gary Gilleskie and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-09-07 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:

GB/T; GBT - Product Catalog. Translated English of Chinese Standard. (GB/T; GBT)

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Publisher : https://www.chinesestandard.net
ISBN 13 :
Total Pages : 2259 pages
Book Rating : 4./5 ( download)

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Book Synopsis GB/T; GBT - Product Catalog. Translated English of Chinese Standard. (GB/T; GBT) by : https://www.chinesestandard.net

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Compounding Sterile Preparations

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Publisher : ASHP
ISBN 13 : 1585286508
Total Pages : 1069 pages
Book Rating : 4.5/5 (852 download)

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Book Synopsis Compounding Sterile Preparations by : Ryan Forrey

Download or read book Compounding Sterile Preparations written by Ryan Forrey and published by ASHP. This book was released on 2023-11-13 with total page 1069 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of Compounding Sterile Preparations by Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv reflects the latest advancements in the field, providing you with an indispensable resource to navigate the complex landscape of sterile compounding. New in this Edition: Updated Standards: All chapters have undergone extensive revisions to align with the most recent literature and the revised USP standards. USP Chapter : Now includes information on radiopharmaceutical compounding in USP Chapter . Expanded Knowledge Base: Two brand-new chapters covering Allergenic Extracts and Corrective and Preventative Action (CAPA) Plans.

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Handbook of Validation in Pharmaceutical Processes, Fourth Edition by : James Agalloco

Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture