Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries, 1st Edition (e-Book) book cover

Cleaning Validation Manual

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries, 1st Edition

By Syed Imtiaz Haider

CRC Press

608 pages

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Paperback: 9781138749719
pub: 2018-07-31
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pub: 2010-05-24
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pub: 2010-05-24
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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-

Table of Contents

CLV-1 How to Establish a Cleaning Validation Program. CLV-2 Introduction. CLV-3 Scope and Approach. CLV-4 Cleaning Validation Team Members and Responsibilities. CLV-5 Cleaning Validation Philosophy, Strategies, and Methodology. CLV-6 Planning Phase. CLV-7 Execution Phase. CLV-8 Analytical Testing and Reporting Phase. CLV-9 Equipment Description. CLV-10 Facility Description. CLV-11 Utilities Description: DIW, WFI, Steam, and Compressed Air. CLV-12 Utilities Monitoring and Microbiological Control. CLV-13 Equipment Cleaning Materials/Detergent Description. CLV-14 Microbiological Cleaning of Equipment Surface. CLV-15 Solubility of Active Materials in Water. CLV-16 Toxicity of Active Materials. CLV-17 Cleaning Validation Products Grouping Matrix (Tablets, Capsules, and PPS). CLV-18 Product/Equipment Train Matrix (Tab-Cap-PPS). CLV-19 Worst-Case Products (Tablets, Capsules, and PPS) Matrix. CLV-20 Validation with Corresponding Cleaning Procedures. CLV-20.1 Cleaning Validation Protocol for Fluid Bed Dryer. CLV-20.2 Cleaning Validation Protocol for Mixer. CLV-20.3 Cleaning Validation Protocol for Granulation Machines (Type A). CLV-20.4 Cleaning Validation Protocol for Powder Bins. CLV-20.5 Cleaning Validation Protocol for Tablet Press. CLV-20.6 Cleaning Validation Protocol for Sieve. CLV-20.7 Cleaning Validation Protocol for Powder-Filling Machine. CLV-20.8 Cleaning Validation Protocol for Encapsulation Machine. CLV-20.9 Cleaning Validation Protocol for Film Coating Pan. CLV-20.10 Cleaning Validation Protocol for Sugar Coating Pan. CLV-21 Cleaning Validation Product Grouping Matrix (Syrup). CLV-22 Cleaning Validation Product/Equipment Train (Syrup). CLV-23 Worst-Case Products (Syrup). CLV-24 Cleaning Validation Product Grouping Matrix (Suspension). CLV-25 Product Grouping/Equipment Train Matrix (Suspension). CLV-26 Worst-Case Products (Suspension). CLV-27 Product Grouping Matrix (Drops). CLV-28 Product/Equipment Train (Drops). CLV-29 Worst-Case Products (Drops). CLV

About the Author

Syed Imtiaz Haider and Erfan Syed Asif are with Gulf Pharmaceutical Industries in the United Arab Emirates.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology