1st Edition

Cleaning Validation Manual A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

By Syed Imtiaz Haider Copyright 2011
    608 Pages 120 B/W Illustrations
    by CRC Press

    608 Pages 120 B/W Illustrations
    by CRC Press

    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-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.

    With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary.

    Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

    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-30 Cleaning Validation Product Grouping Matrix (Cream/Ointment) 
    CLV-31 Product/Equipment Train (Cream and Ointment)
    CLV-32 Worst-Case Products (Ointment and Cream)
    CLV-33 Product Grouping Matrix (Suppositories)
    CLV-34 Cleaning Validation Product/Equipment Train (Suppositories)
    CLV-35 Worst-Case Products (Suppositories)
    CLV-36 Cleaning Validation Protocols Products (Suppositories)
    CLV-36.1 Protocol for Manufacturing Vessel
    CLV-36.2 Protocol for Bin Washing Station
    CLV-36.3 Cleaning Validation Protocol for Syrup Holding Tank
    CLV-36.4 Protocol for Filling Station and Filter Assembly
    CLV-37 Cleaning Validation Product Grouping Matrix (Sterile)
    CLV-38 Cleaning Validation Product/Equipment Train Matrix (Sterile)
    CLV-39 Validation Protocols Biological and Sterile Products
    CLV-39.1 Cleaning Validation Protocol for Freeze Dryer
    CLV-39.2 Cleaning Validation Protocol for Glass-Lined Mobile Tank
    CLV-39.3 Protocol for Preparation and Holding Vessel for Egg Protein
    CLV-39.4 Protocol for Filtration Assembly
    CLV-39.5 Protocol for Preparation and Holding Vessels for Biological Products
    CLV-39.6 Protocol for Filtration Assembly and Filling Machine for Biological Products
    CLV-40 Cleaning Validation Tentative Plan (Schedule)
    CLV-41 Cleaning Validation Sampling and Testing Status
    CLV-42 Cleaning Validation Regulatory Guidelines
    CLV-42.1 Guide to Inspections Validation of Cleaning Processes
    CLV-42.2 WHO Good Manufacturing Guidelines for Cleaning Validation
    CLV-42.3 Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines GUIDE-0028
    CLV-42.4 Qualifi cation and Validation
    CLV-43 Sampling Tools
    CLV-44 Recommended Readings


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