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 what’s 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:
[email protected] 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
1
Why Read this Book?
2
Scope
3
Definitions
4
Drinking Water
4
Highly Purified Water
4
Municipal Water
4
Potable Water
4
Purified Water
5
Applicable Regulations, Standards, and Guidelines
6
Purified Water Monographs
9
US Pharmacopoeia
9
European Pharmacopoeia
9
FDA Applicable Parts
10
ASME BPE
11
European Standards for Welding
11
ASME Boiler & Pressure Vessel Code
12
Pressure Equipment Directive 97/23/EC PED (Europe)
12
Electrical Standards
13
International
13
USA
13
Europe
13
An Easy to Understand Guide | Validating Purified Water Systems
Machinery Directive 2006/42/EC (Europe)
14
Water and Steam Systems
14
GAMP Guide
14
ICH Requirements
15
ASTM E 2500 Standard
15
Planning
17
Who Should Be Involved
18
What to Know
18
User Requirement Specification
20
URS Content
20
URS Format and Layout
26
Audits
35
Design Basics
39
Required Data
41
Quality by Design (QbD) Concept
41
Design on a Budget
42
Overview of Production of Purified Water
44
Pre-treatment
44
Reverse Osmosis (RO)
45
Continuous Electrodeionization (CEDI)
46
Storage Tank
47
Distribution System
48
An Easy to Understand Guide | Validating Purified Water Systems
Risk Analysis
48
Definition of Product-wetted Side
50
Design Documentation
50
Piping and Instrumentation Drawing (P&ID)
50
Functional Specification
51
Detailed Design
51
Design Approval Milestones
52
Component Procurement System
53
Procurement Procedure
54
System Requirements Communication
54
Receiving Inspections
55
Receiving Inspections: Time sensitive
56
Common Mistakes
58
Example # 1
59
Example # 2
59
System Quality
62
Mechanical System
63
Automation
64
Validation
66
Overview
67
Validation Documentation
67
An Easy to Understand Guide | Validating Purified Water Systems
Validation Activities
68
Validation Mistakes
69
Validation Protocols
71
Test Selection
71
Common Verifications
75
When to test
78
Test Layout and Content
79
Validation Protocol Execution Success
82
Maintaining the Validated State
83
System Turnover Package
85
Design Documentation
87
Technical Documentation
87
Certificates
87
Welding Documentation
88
Validation Documentation
88
Change Control
89
Maintenance and Service
90
Conclusion
92
A
93 Abbreviations
B
93 96
References
96
An Easy to Understand Guide | Validating Purified Water Systems
US Pharmacopoeia
96
European Pharmacopoeia
96
FDA Applicable Parts
96
Standards for Welding
97
Miscellaneous
98
An Easy to Understand Guide | Validating Purified Water Systems
