C3-P4 Vol. 25 No. 13 Preparation and Testing of Reagent ...

C3-P4

Vol. 25 No. 13

Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition

PLEASE

This proposed document is published for wide and thorough review in the new, accelerated Clinical and Laboratory Standards Institute (CLSI) consensus-review process. The document will undergo concurrent consensus review, Board review, and delegate voting (i.e., candidate for advancement) for 90 days. Please send your comments on scope, approach, and technical and editorial content to CLSI.

Comment period ends

6 September 2005

The subcommittee responsible for this document will assess all comments received by the end of the comment period. Based on this assessment, a new version of the document will be issued. Readers are encouraged to send their comments to the Clinical and Laboratory Standards Institute Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA; Fax: +610.688.0700, or to the following e-mail address: [email protected]

COMMENT

This document provides guidelines on water purified for clinical laboratory use; methods for monitoring water quality and testing for specific contaminants; and water system design considerations. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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Clinical and Laboratory Standards Institute Providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards The Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues. Our process is based on the principle that consensus is an effective and cost-effective way to improve patient testing and healthcare services.

In addition to developing and promoting the use of voluntary consensus standards and guidelines, we provide an open and unbiased forum to address critical issues affecting the quality of patient testing and health care.

PUBLICATIONS

A document is published as a standard, guideline, or committee report.

Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified.

Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs.

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CONSENSUS PROCESS

The CLSI voluntary consensus process is a protocol establishing formal criteria for:

• the authorization of a project

• the development and open review of documents

• the revision of documents in response to comments by users

• the acceptance of a document as a consensus standard or guideline.

Most documents are subject to two levels of consensus—“proposed” and “approved.” Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate consensus level.

Proposed A consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a line-by-line review of its technical and editorial content.

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Our standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested parties obtained by following CLSI’s established consensus procedures. Provisions in CLSI standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations.

COMMENTS

The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA.

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Healthcare professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact us at [email protected] or +610.688.0100 for additional information on committee participation.



C3-P4 ISBN 1-56238-570-4

Volume 25 Number 13 ISSN 0273-3099

Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition W. Gregory Miller, PhD, DABCC, FACB Erich L. Gibbs, PhD Dennis W. Jay, PhD, DABCC, FACB Kenneth W. Pratt, PhD Bruno Rossi, MS Christine M. Vojt, MT(ASCP), MS Paul Whitehead, PhD, CChem, FRSC Abstract CLSI document C3-P4, Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition provides information on water purity requirements for clinical laboratory testing, validation of specifications, technology available for water purification, and test procedures to monitor and trend water purity parameters. Clinical and Laboratory Standards Institute (CLSI). Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition. CLSI document C3-P4 (ISBN 1-56238-570-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the healthcare community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: [email protected]; Website: www.clsi.org



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This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system, transmitted, or made available in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from Clinical and Laboratory Standards Institute, except as stated below. Clinical and Laboratory Standards Institute hereby grants permission to reproduce limited portions of this publication for use in laboratory procedure manuals at a single site, for interlibrary loan, or for use in educational programs provided that multiple copies of such reproduction shall include the following notice, be distributed without charge, and, in no event, contain more than 20% of the document’s text.

Reproduced with permission, from CLSI publication C3-P4—Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition (ISBN 1-56238-570-4). Copies of the current edition may be obtained from Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA.

Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from Clinical and Laboratory Standards Institute by written request. To request such permission, address inquiries to the Executive Vice President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA. Copyright ©2005. Clinical and Laboratory Standards Institute. Suggested Citation (Clinical and Laboratory Standards Institute. Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition. CLSI document C3-P4 [ISBN 1-56238-570-4]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.) Proposed Standard—First Edition Tentative Guideline—Second Edition January 1976 December 1988 Tentative Standard—First Edition Approved Guideline—Second Edition January 1978 August 1991 Approved Standard—First Edition Approved Guideline—Third Edition February 1980 October 1997 Proposed Guideline—Second Edition Proposed Guideline—Fourth Edition June 1985 June 2005 ISBN 1-56238-570-4 ISSN 0273-3099



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Committee Membership Area Committee on Clinical Chemistry and Toxicology W. Gregory Miller, PhD Chairholder Virginia Commonwealth University Richmond, Virginia David A. Armbruster, PhD, DABCC, FACB Vice-Chairholder Abbott Laboratories Abbott Park, Illinois John Rex Astles, PhD, FACB Centers for Disease Control and Prevention Atlanta, Georgia David M. Bunk, PhD National Institute of Standards and Technology Gaithersburg, Maryland Neil Greenberg, PhD Ortho-Clinical Diagnostics, Inc. Rochester, New York Christopher M. Lehman, MD Univ. of Utah Health Sciences Center Salt Lake City, Utah Richard R. Miller, Jr. Dade Behring Inc. Newark, Delaware Michael E. Ottlinger, PhD, DABT U.S. Environmental Protection Agency Cincinnati, Ohio

Linda Thienpont University of Ghent Gent, Belgium Thomas L. Williams, MD Methodist Hospital Omaha, Nebraska Advisors Larry D. Bowers, PhD, DABCC U.S. Anti-Doping Agency Colorado Springs, Colorado Robert W. Burnett, PhD Hartford Hospital Farmington, Connecticut Mary F. Burritt, PhD Mayo Clinic Rochester, Minnesota Paul D’Orazio, PhD Instrumentation Laboratory Lexington, Massachusetts Carl C. Garber, PhD, FACB Quest Diagnostics, Incorporated Teterboro, New Jersey Uttam Garg, PhD, DABCC Children’s Mercy Hospital Kansas City, Missouri

David E. Goldstein, MD Univ. of Missouri School of Medicine Columbia, Missouri Harvey W. Kaufman, MD Quest Diagnostics, Incorporated Lyndhurst, New Jersey Gary L. Myers, PhD Centers for Disease Control and Prevention Atlanta, Georgia David Sacks, MD Brigham and Women’s Hospital and Harvard Medical School Boston, Massachusetts Bette Seamonds, PhD Mercy Health Laboratory Swarthmore, Pennsylvania Dietmar Stöckl, PhD University of Ghent Gent, Belgium Hubert Vesper, PhD Centers for Disease Control and Prevention Atlanta, Georgia Jack Zakowski, PhD, FACB Beckman Coulter, Inc. Brea, California

Working Group on Reagent Water W. Gregory Miller, PhD, Chairholder Virginia Commonwealth University Richmond, Virginia Erich L. Gibbs, PhD High-Q, Inc. Wilmette, Illinois Dennis W. Jay, PhD, DABCC, FACB St. Jude Children’s Research Hospital Memphis, Tennessee

Kenneth W. Pratt, PhD National Institute of Standards and Technology Gaithersburg, Maryland Bruno Rossi, MS Millipore SAS Guyancourt, France Christine M. Vojt, MT(ASCP), MS Ortho-Clinical Diagnostics, Inc. Rochester, New York Paul Whitehead, PhD, CChem, FRSC Elga LabWater, Lane End, Bucks, United Kingdom

Advisors Kelli Buckingham-Meyer Montana State University Bozeman, Montana Darla M. Goeres, MS Montana State University Bozeman, Montana Marilyn J. Gould, PhD Falmouth, Massachusetts Zenaida Maicas, PharmD Cape Neddick, Maine



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Advisors (Continued) Stephane Mabic Millipore SAS Guyancourt, France Alan Mortimer, CChem, FRSC Elga LabWater, Lane End, Bucks, United Kingdom Keith W. Richardson Associates of Cape Cod, Inc. Woods Hole, Massachusetts

Staff Clinical and Laboratory Standards Institute Wayne, Pennsylvania Tracy A. Dooley, BS, MLT(ASCP) Staff Liaison

Donna M. Wilhelm Editor Melissa A. Lewis Assistant Editor



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Contents

Abstract ....................................................................................................................................................i

Committee Membership........................................................................................................................ iii

Foreword.............................................................................................................................................. vii

1 Scope..........................................................................................................................................1

2 Introduction................................................................................................................................1

3 Definitions .................................................................................................................................2

4 Specifications.............................................................................................................................5 4.1 Organization of Water Purity Specifications ................................................................6 4.2 Clinical Laboratory Reagent Water (CLRW) ...............................................................7 4.3 Special Reagent Water (SRW)......................................................................................8 4.4 Instrument Feed Water..................................................................................................8 4.5 Water Supplied by a Method Manufacturer for Use as a Diluent or Reagent ..............8 4.6 Prepackaged Bottled Water...........................................................................................8 4.7 Autoclave and Wash Water Applications .....................................................................9

5 Validation and Trend Monitoring ..............................................................................................9 5.1 Validation of Purified Water as Fit for Its Intended Purpose in Laboratory

Procedures.....................................................................................................................9 5.2 Trend Monitoring of Water Purity Specifications ......................................................10 5.3 Water Purification System Validation ........................................................................11

6 Design Considerations .............................................................................................................12 6.1 Filters ..........................................................................................................................13 6.2 Reverse Osmosis (RO) Membranes............................................................................14 6.3 Contactor Membranes.................................................................................................15 6.4 Ion-Exchange Resins ..................................................................................................15 6.5 Activated Carbon ........................................................................................................17 6.6 Distillation ..................................................................................................................18 6.7 Ultraviolet Light .........................................................................................................20 6.8 Storage and Distribution .............................................................................................21

7 Testing .....................................................................................................................................23 7.1 Resistivity ...................................................................................................................23 7.2 Microbial Content by Colony Count...........................................................................28 7.3 Microbial Content by Epifluorescence Microscopy ...................................................29 7.4 Endotoxins ..................................................................................................................32 7.5 Determination of Oxidizable Organic Substances, Expressed as Total Organic Carbon (TOC) .............................................................................................................34

References.............................................................................................................................................40

Additional References...........................................................................................................................42

Appendix A. Permeability of Plastic Piping to Atmospheric CO2.......................................................43



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Contents (Continued)

Appendix B. Resistivity Measurement in a Sparged Water Sample....................................................45

Appendix C. Methods for Correction or Compensation of Resistivity Measurements .......................47

Summary of Comments and Subcommittee Responses........................................................................49

The Quality System Approach..............................................................................................................50

Related CLSI/NCCLS Publications ......................................................................................................51



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Foreword This edition of the guideline includes updated information regarding the preparation and testing of reagent water in clinical laboratories. Specifications are based on measuring parameters that serve as indicators for the total ionic, organic, and microbial contamination. Emphasis is placed on the value of trending these parameters as an effective way to control the quality and consistency of purified water, as well as the importance of validating that a grade of reagent water is fit for its intended purpose in clinical laboratory testing. A new section provides guidelines for water purification system validation, ongoing maintenance, and revalidation on a recurring schedule. The Type I, II, III designations for grades of purified water, used in the previous edition, have been replaced with purity grades that provide more meaningful specifications for clinical laboratory testing. Clinical laboratory reagent water (CLRW) can be used in place of Type I and Type II water for most applications. Autoclave and wash water will generally be satisfactory replacement for Type III water. The definitions of the new grades of water include a number of parameters that were not used in previous editions and do not use some of the parameters that were used in previous editions. Resistivity measurement has been retained to monitor inorganic impurities. The previous edition recommended that water purification systems include a stage to reduce organic contamination, but required no control. This edition recognizes that organic contamination can be difficult to remove from feed water, can be introduced by components of water purification systems or biofilms, and must be controlled. Therefore, a total organic carbon (TOC) parameter has been added. Note that on-line or in-house measurements of TOC are not required. It is acceptable to send CLRW samples to a referral laboratory for TOC measurement. (See Section 7.5 for additional information on contamination issues when TOC is at low levels.) Plate counting of colonies is a widely used method for monitoring the level of microorganisms in purified laboratory water, and this edition continues to specify this approach. However, epifluorescence and endotoxin testing have been added as optional tests, because they provide additional information and results can be determined quickly. Specifications and methods for measuring pH, SiO2, and sterility have not been carried forward from the previous edition. Resistivity is more sensitive than pH to H+ and OH- contamination. Resistivity is not a sensitive indicator of weakly ionized contaminants, which may elute as concentrated pulses from ion- exchange beds when they approach depletion. However, the release of weakly ionized contaminants (silica being but one example) can be avoided by appropriate design and regular maintenance of ion-exchange components. A parameter for sterility has not been included in this edition of the guideline, because most laboratory applications do not require sterile water. When necessary, water can be sterilized; however, the method of sterilization must not degrade the purity of the water. Key Words Clinical laboratory water, high-purity water, purified water, reagent water, water purification Invitation for Participation in the Consensus Process An important aspect of the development of this and all CLSI documents should be emphasized, and that is the consensus process. Within the context and operation of CLSI, the term “consensus” means more than agreement. In the context of document development, “consensus” is a process by which CLSI, its members, and interested parties (1) have the opportunity to review and to comment on any CLSI publication; and (2) are assured that their comments will be given serious, competent consideration. Any



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CLSI document will evolve as will technology affecting laboratory or healthcare procedures, methods, and protocols; and therefore, is expected to undergo cycles of evaluation and modification. The Area Committee on Clinical Chemistry and Toxicology has attempted to engage the broadest possible worldwide representation in committee deliberations. Consequently, it is reasonable to expect that issues remain unresolved at the time of publication at the proposed level. The review and comment process is the mechanism for resolving such issues. The CLSI voluntary consensus process is dependent upon the expertise of worldwide reviewers whose comments add value to the effort. At the end of a 90-day comment period, each subcommittee is obligated to review all comments and to respond in writing to all which are substantive. Where appropriate, modifications will be made to the document, and all comments along with the subcommittee’s responses will be included as an appendix to the document when it is published at the next consensus level.



Volume 25 C3-P4

©Clinical and Laboratory Standards Institute. All rights reserved. 1

Preparation and Testing of Reagent Water in the Clinical Laboratory; Proposed Guideline—Fourth Edition

1 Scope Purified water requirements are specified for clinical laboratory testing procedures. The following purity grades are described: • clinical laboratory reagent water (CLRW); • special reagent water (SRW); • instrument feed water; • autoclave and wash water; and • commercially available bottled water. Procedures are provided for measuring and trending parameters to control ionic, organic, and microbial contamination in purified laboratory water. Recommendations are provided to control particulate and colloidal contamination. The guideline requires the laboratory to validate a selected grade of water as fit for its intended purpose in laboratory tests. Suggested approaches for validation of water purification systems are included. It is beyond the scope of this guideline to recommend specific types of water purification systems. Instead, the guideline provides information about discrete purification technologies and monitoring strategies that can be applied in various combinations to achieve and maintain the required water purity. 2 Introduction A key element of success in the clinical laboratory is the constancy of test result quality. The physician or caregiver counts on results that represent only patient analyte measurement, not the measurement of microbial or chemical contaminants that may be extraneously introduced during a laboratory procedure. Purified water constitutes the major component of many reagents, buffers, and diluents used in clinical laboratory testing. It can also become an indirect component of tests when it is used for washing and sanitizing instruments and laboratory ware, generating autoclave steam, etc. Purified water is a potential cause of laboratory error. This guideline recommends measuring certain parameters of purified water used in clinical laboratory applications as a means of quality control for purification systems. The parameters are: resistivity, an indicator of ionic contamination; viable plate counts, an indicator of microorganism contamination; and total organic carbon, an indicator of organic contamination. Epifluorescence and endotoxin testing are included as optional approaches for measuring contamination from microbial sources. Particulate contamination is controlled by including appropriate filtration, or distillation, in the purification system. The guideline is not intended to assure the adequacy of purified water for a given laboratory application; rather, water of a specified purity must be validated as fit for use in a particular laboratory application. Any parameters used to specify a grade of purified water, or to monitor the performance of a purification system, should be measured frequently enough to detect potential changes in the system, and the measurements should be trended to detect drift and anticipate maintenance. Other organizations have published guidelines and specifications for purified water intended for various applications. Water conforming to the guidelines and specifications of these organizations may or may not be equivalent to the grades of purified water described in this CLSI guideline. Any type of purified water should be validated as fit for purpose before being used in clinical laboratory testing.



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