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Author: Syed Imtiaz Haider
Publisher: CRC Press
Published: 2010-05-24
Total Pages: 608
ISBN-13: 1439826617
DOWNLOAD EBOOKDuring the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-
Author: James Agalloco
Publisher: CRC Press
Published: 2021-10-28
Total Pages: 1062
ISBN-13: 1000436012
DOWNLOAD EBOOKRevised 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
Author: Michael E. Swartz
Publisher: CRC Press
Published: 2012-04-24
Total Pages: 218
ISBN-13: 142001448X
DOWNLOAD EBOOKWritten for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Author: Dr. Tim Sandle
Publisher: Grosvenor House Publishing
Published: 2012-08-02
Total Pages: 284
ISBN-13: 178148080X
DOWNLOAD EBOOKThe 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.
Author:
Publisher:
Published: 1987
Total Pages: 32
ISBN-13:
DOWNLOAD EBOOKAuthor: Barbara Kanegsberg
Publisher: CRC Press
Published: 2011
Total Pages: 576
ISBN-13: 1439828296
DOWNLOAD EBOOK"Nearly all companies which manufacture or fabricate high-value physical objects (components, parts, assemblies) perform critical cleaning at one or more stages. These range from the giants of the semiconductor, aerospace, and biomedical world to a host of small to medium to large companies producing a dizzying array of components"--
Author: Satinder Ahuja
Publisher: Elsevier
Published: 2005-02-09
Total Pages: 679
ISBN-13: 0080455182
DOWNLOAD EBOOKHigh pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Author: Michael E. Swartz
Publisher: CRC Press
Published: 2012-04-24
Total Pages: 226
ISBN-13: 0824706897
DOWNLOAD EBOOKWritten for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.
Author: Barbara Kanegsberg
Publisher: CRC Press
Published: 2017-06-21
Total Pages: 1136
ISBN-13: 9781138074576
DOWNLOAD EBOOK"Nearly all companies which manufacture or fabricate high-value physical objects (components, parts, assemblies) perform critical cleaning at one or more stages. These range from the giants of the semiconductor, aerospace, and biomedical world to a host of small to medium to large companies producing a dizzying array of components"--
Author: Robert Packard
Publisher:
Published: 2015-04-05
Total Pages: 258
ISBN-13: 9780967311524
DOWNLOAD EBOOKReference text on validation processes for manufacturing medical devices.
