An Easy to Understand Guide

Validating Purified Water Systems

The Validation Specialists

askaboutValidation
Connecting the Life Sciences

An Easy to Understand Guide

Validating Purified Water Systems

Published by Premier Validation

An Easy to Understand Guide | Validating Purified Water Systems

Designing, Building, and Validating Purified Water Treatment Systems First Edition Copyright 2012 Premier Validation All rights reserved. No part of the content or the design of this book maybe reproduced or transmitted in any form or by any means without the express written permission of Premier Validation. The advice and guidelines in this book are based on the experience of the authors, after more than a decade within the Life Science industry, and as such is either a direct reflection of the predicate rules (the legislation governing the industry) or are best practices used within the industry. The author takes no responsibility for how this advice is implemented. Visit Premier Validation on the web at www.premiervalidation.com or visit our forum at www.askaboutvalidation.com.

An Easy to Understand Guide | Validating Purified Water Systems

So whats this book all about?

Hey there, If you've decided to invest some time in reading this book, I am making the assumption that you are pretty tired of wading through scientific white papers and 500 page books designed to confuse the hell out of everyone! This quick and easy guide describes how to design, build, and validate a purified water treatment system according to current quality regulations and standards. This guide begins at the incoming water into a facility, which should be of drinking quality, and ends with the distribution points of the purified water system. This book has been written for anyone new to water treatment projects and the validation required to bring them to the required state of compliance. It will also determine which regulations and standards are applicable together with a lot more useful information required for any purified water treatment system project. Enjoy!

An Easy to Understand Guide | Validating Purified Water Systems

The brains behind the operation!

Program Director: Graham O'Keeffe Content Author: Annelie H King Technical Editor: Alan Smith, Graham O'Keeffe, Peter Jacobs, Irene Kaas. Editor: Anne-Marie Smith Printing History: Edition: Aug 2012 Cover and Graphic Design: Those Concepts

Notes of Rights
All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright holder, except in the case of brief quotations embedded in critical articles or reviews.

Notes of Liability
The author and publisher have made every effort to ensure the accuracy of the information herein. However, the information contained in this book is sold without warranty, either express or implied. Neither the authors and Premier Validation Ltd, nor its dealers or distributors will be held liable for any damages to be caused either directly or indirectly by the instructions contained in this book.

The Validation Specialists

Published by Premier Validation Ltd Web: www.premiervalidation.com Forum: www.askaboutvalidation.com Email: query@premiervalidation.com ISBN 978-1-908084-09-5 Print and bound in the United Kingdom

An Easy to Understand Guide | Validating Purified Water Systems

Table of Contents
Introduction Why Read this Book? Scope Definitions Drinking Water Highly Purified Water Municipal Water Potable Water Purified Water 1 2 3 4 4 4 4 4 5

Applicable Regulations, Standards, and Guidelines Purified Water Monographs US Pharmacopoeia European Pharmacopoeia FDA Applicable Parts ASME BPE European Standards for Welding ASME Boiler & Pressure Vessel Code Pressure Equipment Directive 97/23/EC PED (Europe) Electrical Standards International USA Europe

6 9 9 9 10 11 11 12 12 13 13 13 13

An Easy to Understand Guide | Validating Purified Water Systems

Machinery Directive 2006/42/EC (Europe) Water and Steam Systems GAMP Guide ICH Requirements ASTM E 2500 Standard

14 14 14 15 15

Planning Who Should Be Involved What to Know User Requirement Specification URS Content URS Format and Layout Audits

17 18 18 20 20 26 35

Design Basics Required Data Quality by Design (QbD) Concept Design on a Budget Overview of Production of Purified Water Pre-treatment Reverse Osmosis (RO) Continuous Electrodeionization (CEDI) Storage Tank Distribution System

39 41 41 42 44 44 45 46 47 48

An Easy to Understand Guide | Validating Purified Water Systems

Risk Analysis Definition of Product-wetted Side Design Documentation Piping and Instrumentation Drawing (P&ID) Functional Specification Detailed Design Design Approval Milestones

48 50 50 50 51 51 52

Component Procurement System Procurement Procedure System Requirements Communication Receiving Inspections Receiving Inspections: Time sensitive Common Mistakes Example # 1 Example # 2

53 54 54 55 56 58 59 59

System Quality Mechanical System Automation

62 63 64

Validation Overview Validation Documentation

66 67 67

An Easy to Understand Guide | Validating Purified Water Systems

Validation Activities Validation Mistakes Validation Protocols Test Selection Common Verifications When to test Test Layout and Content Validation Protocol Execution Success Maintaining the Validated State

68 69 71 71 75 78 79 82 83

System Turnover Package Design Documentation Technical Documentation Certificates Welding Documentation Validation Documentation

85 87 87 87 88 88

Change Control Maintenance and Service Conclusion A Abbreviations B References

89 90 92 93 93 96 96

An Easy to Understand Guide | Validating Purified Water Systems

US Pharmacopoeia European Pharmacopoeia FDA Applicable Parts Standards for Welding Miscellaneous

96 96 96 97 98

An Easy to Understand Guide | Validating Purified Water Systems