New Standardization and robotization in pipette calibration

Uri Maurice, QCC Hazorea, Kibbutz Hazorea, Israel (uri_ma@mba.co.il)

Pipette calibration is a critical aspect of ensuring accuracy and precision in liquid handling, particularly in laboratories operating under strict quality control systems. The ISO 8655:2022 & ISO 20461:2023standards represent the latest revision in the international framework governing the calibration, performance testing, and specification of piston-operated volumetric apparatus. This updated standard reflects significant changes from previous versions, including updated metrological requirements, improved uncertainty estimation guidelines, detailed specifications for both manual and automated pipettes, and a new approach to compliance decision.

One of the key advancements in ISO 8655:2022 is the harmonization of calibration procedures and error limits across different pipette types and volumes. It emphasizes the use of gravimetric methods under controlled environmental conditions and tip change and series requirements, and provides clearer guidelines for calculating systematic (accuracy) and random (precision) errors. The standard now includes detailed measurement uncertainty components, allowing laboratories to better understand and quantify the reliability of their pipetting systems. In addition, the new version accounts for multi-channel pipettes and offers expanded annexes addressing calibration frequencies, maintenance, and operator training, which are crucial for Good Laboratory Practice (GLP) and ISO/IEC 17025 compliance.

The 2022 revision recommends that calibration intervals be determined based on risk assessment, usage intensity, and criticality of application, while upholding a maximum interval requirement.

The advancement of standardization also requires attention to a few more questions: should probability of conformity be taken into account or is a binary statement sufficient? How to calibrate over 12 channel pipettes according to the standard? (currently impossible), and can the calibration process be automized or even roboticized?

The lecture will address all the above questions and unveil the next generation of POVA calibrations developed right here, in Israel.