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

Cleaning Validation Manual

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

By Syed Imtiaz Haider

CRC Press

608 pages | 120 B/W Illus.

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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

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:
MEDICAL / Pharmacology