“The only reason for time is so that everything doesn’t happen at once.”
– Albert Einstein
Despite Einstein’s assurance, it does seem that almost everything is happening almost all at once in the world of liquid handling standards. The year 2015 will see the publication of the new ISO/IWA 15 standard for automated pipetting systems, and important work to revise the ISO 8655 series of standards. In addition, a further revision of the current ASTM E1154 version (released in December 2014) is being planned for this year. Let’s take these topics in order.
ISO/IWA 15 is a just-completed standard which harmonizes methods for the determination of volumetric performance of automated liquid handling systems. This will benefit laboratories worldwide by providing a consistent basis for evaluating and validating volumetric performance. Standardized data collection and evaluation will increase clarity for users and manufacturers when assessing the performance of liquid handling systems – and therefore achieving increased confidence in the results of laboratory processes. This will not only save time and money but, in allowing greater harmonization of practices, will contribute to improving laboratory quality and efficiency – speeding development and availability of drugs and diagnostics, and therefore advancing healthcare globally. You can download a flyer describing ISO/IWA 15 at www.iwa15.org.
Specifically addressing the determination of trueness and precision of automated liquid handlers, the new standard is based on the consensus agreement among a broad spectrum of participating organizations. The working group included many of the major manufacturers of automated liquid handling systems, as well as leading manufacturers of volume testing equipment and test service organizations. Instrument users are also a critical constituency, and the participants included representatives from pharmaceutical, clinical and biotechnology laboratories plus academic and government research organizations.
The technical content of ISO/IWA 15 was reviewed during the SLAS meeting in Washington DC earlier this year, and also at the recent ACHEMA conference in Frankfurt, Germany, where my colleague Dr. Bjoern Carle presented a fascinating A-Z overview of the background, current importance and future of volumetric performance assessment.
We are all excited about ISO/IWA 15 and the benefits it can bring to individual laboratories, global organizations and to healthcare generally. ISO is now readying the document for publication and availability. I expect that next time you hear from me on this issue – in a month or so – ISO/IWA 15 will be ready for any forward-thinking laboratory to implement. Of course, all of us are eager to help any interested parties take advantage of this new development, and we encourage you to contact Renata Koerfer or me, as described in the press release.
I am happy to report that there will be an ISO working group meeting in Portland, Maine this September, where the focus of the participants—a global team from multiple organizations—will be to refine the usability and benefits of the ISO 8655 series of standards. These standards pertain to assessment of the volumetric performance of handheld pipetting and related piston-operated liquid handling devices. First published in 2002, the standards are now due for a revision, based on the wealth of experience and knowledge gained since that time in the technology, performance, and usage of handheld pipettes. The meeting will encompass a variety of perspectives, and we anticipate getting many new thoughts on the table, and making significant progress.
The last downpour of the year, in the world of liquid handling standards, relates to the December 2014 publication of the most recent version of ASTM E 1154 – “Standard Specification for Piston or Plunger Operated Volumetric Apparatus.” The 2014 version included greater clarity in the balance resolution requirements when using the weighing method to calibrate pipettes and similar devices. It also clarifies the mathematical basis of the balance precision requirement, and how compliance is demonstrated. For example, it is now clear that weighing volumes in the range of one to ten microliters requires a six or seven place balance capable of achieving a standard deviation of 0.002 milligrams or better.
The additional revision of ASTM E 1154 now planned will incorporate the latest equations for most accurately accomplishing conversion of weight to volume. This will provide a standard set of the most detailed equations which can be implemented in software to enable accurate computation of delivered volume – something of critical importance to laboratories concerned with pipette performance.
If you are interested in any of the projects mentioned here, please contact me. I look forward to hearing from you!
George Rodrigues, Ph.D., is Senior Scientific Manager at Artel, the global leader in liquid delivery quality assurance. Rodrigues is responsible for developing and delivering communications and consulting programs designed to maximize laboratory quality and productivity through science-based management of liquid delivery. Rodrigues is Artel’s chief representative to key commercial clients, government regulatory bodies and industry organizations. His speaking and teaching engagements, along with his publications, build awareness of the challenges and solutions for laboratories in maintaining data integrity and confidence in their testing protocols. He plays a key role in developing the manufacturing and quality assurance processes for Artel products and organizes programs to assist pharmaceutical, biotechnology and clinical laboratories in improving their liquid delivery quality assurance and analytical process control. Rodrigues earned his BS in Chemical Engineering at the U.C. Berkeley, and a PhD in Chemical Engineering at the University of Wisconsin.