Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries By Syed Imtiaz Haider, Syed Erfan Asif

Features

• Supplies a basic education of cleaning validation
• Gives an advanced approach to validation professionals who are already in the field to implement and execute a thorough cleaning validation program
• Includes 23 easy-to-use template protocols for cleaning validation of extensively and most commonly used equipments, with sampling points identified through pictures
• Covers a wide range of active ingredients, including their level of solubility in water and potency/toxicity so as to provide an easy way for validation professionals to create a worst-case matrix for different equipment
• Provides a complete tool to understand, learn, think, and implement a validation program

Summary

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.

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-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