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

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 a CD-ROM 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.

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

CLV-1 How to Establish a Cleaning Validation ProgramCLV-2 IntroductionCLV-3 Scope and ApproachCLV-4 Cleaning Validation Team Members and Responsibilities CLV-5 Cleaning Validation Philosophy, Strategies, and Methodology CLV-6 Planning PhaseCLV-7 Execution PhaseCLV-8 Analytical Testing and Reporting PhaseCLV-9 Equipment Description CLV-10 Facility Description CLV-11 Utilities Description: DIW, WFI, Steam, and Compressed AirCLV-12 Utilities Monitoring and Microbiological ControlCLV-13 Equipment Cleaning Materials/Detergent Description CLV-14 Microbiological Cleaning of Equipment SurfaceCLV-15 Solubility of Active Materials in WaterCLV-16 Toxicity of Active MaterialsCLV-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) MatrixCLV-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 PanCLV-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 VesselCLV-36.2 Protocol for Bin Washing StationCLV-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 ProductsCLV-39.1 Cleaning Validation Protocol for Freeze DryerCLV-39.2 Cleaning Validation Protocol for Glass-Lined Mobile Tank CLV-39.3 Protocol for Preparation and Holding Vessel for Egg ProteinCLV-39.4 Protocol for Filtration AssemblyCLV-39.5 Protocol for Preparation and Holding Vessels for Biological Products CLV-39.6 Protocol for Filtration Assembly and Filling Machine for Biological ProductsCLV-40 Cleaning Validation Tentative Plan (Schedule) CLV-41 Cleaning Validation Sampling and Testing StatusCLV-42 Cleaning Validation Regulatory GuidelinesCLV-42.1 Guide to Inspections Validation of Cleaning ProcessesCLV-42.2 WHO Good Manufacturing Guidelines for Cleaning ValidationCLV-42.3 Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines GUIDE-0028CLV-42.4 Qualifi cation and ValidationCLV-43 Sampling ToolsCLV-44 Recommended Readings