VOLUMETRIC PERFORMANCE

OF AUTOMATED

LIQUID HANDLING SYSTEMS

ISO International Workshop Agreement

IWA15.org

WORKSHOP PARTICIPANTS Agilent Technologies, Inc.: Larry Durandette (U.S.A.)Analytik Jena AG: Katrin Undisz, Peter Zimmermann, Thomas Moore (all: Germany)Artel, Inc.: George Rodrigues, A. Björn Carle, John T. Bradshaw (all: U.S.A.)Brand GmbH & Co. KG: Antonio Romaguera, Josef Pfohl (both: Germany)Eppendorf AG: Harald Andrulat (Germany)Gilson, Inc.: Daniel Gilson (U.S.A.), Hervé Le Dorze (France)Hamilton Bonaduz AG: Renato Nay (Switzerland)Integra Biosciences AG: Daniel Bächi, Alex Studer, Ivo Mettier (all: Switzerland) Mettler-Toledo Ltd.: Craig Bush (U.K.)Sartorius AG: Antti Lilleberg (Germany)Tecan Schweiz AG: Werner J. Hälg (Switzerland)Thermo Fisher Scientific Oy: Harri Jernström (Finland)University of Freiburg (IMTEK): Peter Koltay, Andreas Ernst (both: Germany)

WORKSHOP OBSERVERSBritish Columbia Genome Sciences Center: Miruna Bala (Canada)

Hinsdale Pathology Associates: Erlo Roth (U.S.A.)

Merck Research Laboratories: Mary Jo Wildey (U.S.A)

National Virus Reference Laboratory, University College of Dublin: Zoe Yandle (Ireland)

North Carolina State University (BETEC): Nathaniel Hentz (U.S.A.)

CONTACTChair: George Rodrigues, grodrigues@artel-usa.com

Technical Editor: A. Björn Carle, bcarle@artel-usa.com

IWA 15 can be obtained from the Standards catalogue in the ISO Store:www.iso.org/standard/65552.html

WHAT IS ISO/IWA 15 ?

ISO (International Organization for Standardization) is an independent, non-gov-ernmental membership organization and the world’s largest developer of voluntary international standards. Now a familiar factor worldwide in industry and commerce, ISO has a large influence in healthcare, and is committed to promoting harmonization of practices, protecting patient safety, supporting efficient information exchange, and improving the quality of care.

ISO/IWA 15 is a consensus document developed by the workshop participants and observers in response to the need for standardization and harmonization of volumetric performance determination for Automated Liquid Handling Systems (ALHS). This document is the first step to a series of ISO standards addressing this topic.

The principal objective of ISO/IWA 15 is to develop a standards framework within which the users and manufacturers of ALHS can manage the performance and use of these devices.

ISO/IWA 15 describes ALHS test methods, volumetric performance measurement concepts, and descriptive statistics, as well as information to be presented on test reports.

The ISO/IWA 15 workgroup includes representatives from the liquid handling manufactur-ers, calibration providers, and end-users of automated liquid handling instrumentation. The workgroup is continuously open for comment and support from all interested parties.

EXPECTED IMPACT OF STANDARDIZEDMETHODS • Increased efficiencies within, and between, research laboratories.

• Faster development time lines.

• More efficient pursuit of medical advancements.

• Less expensive and more available diagnostics and pharmaceuticals.

• More successful development programs and manufacturing processes of automated liquid handling instrumentation and related laboratory tools essential to healthcare science.

GLOBAL STANDARDIZATIONISO 8655 standardizes the performance determination of non-automated mechanical liquid handling devices, while ISO/IWA 15 addresses automated devices. Both documents harmonize liquid handing performance determination across technology platforms, laboratories and geographic regions.

IWA 15IWA 15

AUTOMATED LIQUID HANDLING SYSTEMS STANDARDS – PRESENT AND FUTURE

Evolution of liquid handling technology toward smaller volumes requires continued

development of increasingly sensitive methods for performance measurement.

Harmonization between test methods is necessary for most efficient laboratory

processes. To date, two ISO standards have been developed for non-automated

liquid handling devices: ISO 4787 for Class A glassware and ISO 8655 for mechanical

piston-operated devices.

The need for standardized measurement methods, statistical analyses, and reporting

requirements for ALHS volumetric performance determinations led to the development

of ISO/IWA 15 under the direction of ISO Technical Committee 48 (ISO/TC 48) -

Laboratory Equipment. It is proposed to develop a series of ISO standards on the basis

of the concepts described in ISO/IWA 15. Consideration of this proposal is being led by

Working Group 04 (WG04) in ISO/TC 48.

ISO/IWA 15 consensus document developed under the direction of ISO/TC 48

Publish ISO/IWA 15

Future work proposed by participants

ISO/TC 48/WG 04 to lead suggestedtechnical projects

Collaboration with measurement research groups

and projects

Series of ISO standards to be developed

CONTEXT FOR THE WORK

The ISO/IWA 15 project exists in the context of the global challenge to meet society’s

needs for affordable, appropriate and available healthcare. Regardless of regional, cultural

or political differences in the approach to healthcare, there is universal agreement that

it is a critical component to progress of any kind - for all societies worldwide. • Affordable: A need for less costly testing, treatment, cure and maintenance.

• Appropriate: A need for accurately executed diagnosis and precisely targeted treatment.

• Available: A need for broader, more timely access to healthcare.

None of these three challenges can be met without more efficient and faster programs in

life science laboratories – to develop new, more effective and less expensive diagnostic

procedures and therapeutic agents. A critical factor in reaching these healthcare goals,

especially as the technical challenges become more complex and involve numerous

parties, is a common system of applied measurement. Without such a system, research

effectiveness and productivity drops, coordination is difficult, costs escalate, needless

complexities arise – and progress suffers dramatically. All of the worthwhile pursuits of

science have been catalyzed by a common system of measurement.

SPECIFIC CONTRIBUTIONS

The ISO/IWA 15 project is envisioned to result in a set of ISO standards specific to users

and manufacturers of automated liquid handling systems. These elements are essential to

development and manufacturing in life sciences – and therefore to meeting the larger

challenges of improved healthcare globally.

ISO/IWA 15 includes:

• Definitions of technical terminology and concepts describing volumetric performance.

• Test methods and descriptive statistics for volume performance determination.

• Guidance for users, developers and manufacturers, including descriptions of testing environments, operating ranges, maximum permissible errors, and reporting requirements.

• Recommendations for continuing work towards a set of ISO standards for ALHS.

Need for ALHS standardization identifiedISO/IWA 15 project initiated

All interested parties are encouraged to participate in this process and visit: IWA15.org for more details.

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