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Author: Jon Voss Publisher: Routledge ISBN: 1351460331 Category : Medical Languages : en Pages : 198
Book Description
This book is intended to serve as a source of practical, technicalinformation for those persons in the biotechnology industry. Casestudies and/ or actual industry examples are used to support the textwherever possible. While much of the material contained within thistext is equally applicable to nonbiopharmaceutical processes, theemphasis has been focused directly upon biopharmaceuticalmanufacturing.Section I provides an in-depth analysis of the design concepts thatlead to cleanable equipment. Also covered in the tirst section arecleaning mechanisms and cleaning systems. The first section isparticularly useful to those persons faced with the task of designingsystems that will be cleaned and also provides the biochemicaloockground of the mechanisms associated with the removal of commonbiotechnology soils.Section II focuses on cleaning validation concepts. While thematerial is equally useful for single product cleaning, emphasis isplaced upon multiproduct cleaning validation. Included in Section IIare general validation principles as thex apply to cleaning validation,detailed analxsis of cleaning process validation, sampling techniques,analytical methods and acceptance criteria. The material in this sectionwill be useful to anyone responsible for the development of a cleaningvalidation program.The final section, Section Ill, provides an overview of multiproductbiotechnology manufacturing procedures. Included in this section is ananalysis of tne risk-to-benefit scenarios associated with the various formsof product manufacturing, analysis of changeover programs, ~uipmentconsiderations, and material transfer systems as they are affected bymultiproduct manufacturing strategies.
Author: Jon Voss Publisher: Routledge ISBN: 1351460331 Category : Medical Languages : en Pages : 198
Book Description
This book is intended to serve as a source of practical, technicalinformation for those persons in the biotechnology industry. Casestudies and/ or actual industry examples are used to support the textwherever possible. While much of the material contained within thistext is equally applicable to nonbiopharmaceutical processes, theemphasis has been focused directly upon biopharmaceuticalmanufacturing.Section I provides an in-depth analysis of the design concepts thatlead to cleanable equipment. Also covered in the tirst section arecleaning mechanisms and cleaning systems. The first section isparticularly useful to those persons faced with the task of designingsystems that will be cleaned and also provides the biochemicaloockground of the mechanisms associated with the removal of commonbiotechnology soils.Section II focuses on cleaning validation concepts. While thematerial is equally useful for single product cleaning, emphasis isplaced upon multiproduct cleaning validation. Included in Section IIare general validation principles as thex apply to cleaning validation,detailed analxsis of cleaning process validation, sampling techniques,analytical methods and acceptance criteria. The material in this sectionwill be useful to anyone responsible for the development of a cleaningvalidation program.The final section, Section Ill, provides an overview of multiproductbiotechnology manufacturing procedures. Included in this section is ananalysis of tne risk-to-benefit scenarios associated with the various formsof product manufacturing, analysis of changeover programs, ~uipmentconsiderations, and material transfer systems as they are affected bymultiproduct manufacturing strategies.
Author: Syed Imtiaz Haider Publisher: CRC Press ISBN: 1439826617 Category : Medical Languages : en Pages : 608
Book Description
During 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: Destin A. LeBlanc Publisher: CRC Press ISBN: 1000835596 Category : Medical Languages : en Pages : 216
Book Description
Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Author: Gil Bismuth Publisher: CRC Press ISBN: 9780367398927 Category : Clean rooms Languages : en Pages : 200
Book Description
Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.
Author: Destin a LeBlanc Publisher: CRC Press ISBN: 9780367398873 Category : Languages : en Pages : 304
Book Description
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.
Author: James Agalloco Publisher: CRC Press ISBN: 1000436012 Category : Medical Languages : en Pages : 1062
Book Description
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
Author: Dr. Tim Sandle Publisher: Grosvenor House Publishing ISBN: 178148080X Category : Health & Fitness Languages : en Pages : 284
Book Description
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.
Author: Mark van der Loo Publisher: John Wiley & Sons ISBN: 1118897153 Category : Computers Languages : en Pages : 316
Book Description
A comprehensive guide to automated statistical data cleaning The production of clean data is a complex and time-consuming process that requires both technical know-how and statistical expertise. Statistical Data Cleaning brings together a wide range of techniques for cleaning textual, numeric or categorical data. This book examines technical data cleaning methods relating to data representation and data structure. A prominent role is given to statistical data validation, data cleaning based on predefined restrictions, and data cleaning strategy. Key features: Focuses on the automation of data cleaning methods, including both theory and applications written in R. Enables the reader to design data cleaning processes for either one-off analytical purposes or for setting up production systems that clean data on a regular basis. Explores statistical techniques for solving issues such as incompleteness, contradictions and outliers, integration of data cleaning components and quality monitoring. Supported by an accompanying website featuring data and R code. This book enables data scientists and statistical analysts working with data to deepen their understanding of data cleaning as well as to upgrade their practical data cleaning skills. It can also be used as material for a course in data cleaning and analyses.
Author: Rajiv Kohli Publisher: Elsevier ISBN: 0815516851 Category : Science Languages : en Pages : 1209
Book Description
Surface contamination is of cardinal importance in a host of technologies and industries, ranging from microelectronics to optics to automotive to biomedical. Thus, the need to understand the causes of surface contamination and their removal is very patent. Generally speaking, there are two broad categories of surface contaminants: film-type and particulates. In the world of shrinking dimensions, such as the ever-decreasing size of microelectronic devices, there is an intensified need to understand the behavior of nanoscale particles and to devise ways to remove them to an acceptable level. Particles which were functionally innocuous a few years ago are ôkiller defectsö today, with serious implications for yield and reliability of the components. This book addresses the sources, detection, characterization and removal of both kinds of contaminants, as well as ways to prevent surfaces from being contaminated. A number of techniques to monitor the level of cleanliness are also discussed. Special emphasis is placed on the behaviour of nanoscale particles. The book is amply referenced and profusely illustrated.• Excellent reference for a host of technologies and industries ranging from microelectronics to optics to automotive to biomedical.• A single source document addressing everything from the sources of contamination to their removal and prevention.• Amply referenced and profusely illustrated.
Author: Jon Voss
Author: Jon Voss
Author: Syed Imtiaz Haider
Author: Destin A. LeBlanc
Author: 
Author: Gil Bismuth
Author: Destin a LeBlanc
Author: James Agalloco
Author: Dr. Tim Sandle
Author: Mark van der Loo
Author: Rajiv Kohli