Simplifying conformance to the new ISO 23783 & ISO 8655 for liquid handling devices
Process standardization for increased quality, data integrity, productivity, and regulatory compliance
Regulatory Compliance & Conformance to ISO Standards are at the heart of data integrity
In the world of liquid handling devices, your lab can find itself in one of two situations: Either your company needs to adhere to legal requirements from the FDA, CLIA, or other regulatory agencies, or your lab simply chooses to align their processes to published consensus standards for increased lab productivity, higher quality results and easier audits. In both cases, there are two ISO standards that are important to note : ISO 23783 for automated liquid handlers (ALH) is brand new, and ISO 8655 for manual liquid handling devices recently underwent major updates. Artel products and services can help you conform to both.
Best Practices include Calibrations and Routine Tests
From the simplest manual handheld device to the most complex automated system, calibration and routine tests are a necessity to ensure data quality and consistent assay performance. While calibration is thorough, routine tests are faster and more frequent checks. Definitions, requirements and acceptable methods for measuring the volumetric performance, including dual-dye ratiometric photometry, are described in ISO 8655 Parts 7 & 8 for manually operated liquid handling devices, and ISO 23783 Part 2 for automated liquid handlers. Both the PCS and MVS facilitate conformity to these standards and provide a complete, packaged, and easy-to-use solution that simplifies implementing these calibration and test procedures in your lab. Alternatively, Artel offers volume verification services so you can stay focused and productive, while we test your automated liquid handlers.
Operator Training is a Growing Necessity
Training lab personnel on proper pipetting technique and regularly evaluating pipetting competency are important, particularly for labs that need to meet regulatory GxP requirements. It involves recording pipetting performance and keeping the documentation handy for auditors. The reason is simple: operator technique is by far the largest source of pipetting variability and errors. The PCS simplifies the operator training and assessment process, by offering an automated self-assessment module to demonstrate pipetting competency, coupled with full audit trail and electronic signatures.
MVS® Multichannel Verification System
Efficiently assess the accuracy and precision of liquid transfers dispensed into each well simultaneously by automated liquid handlers and multichannel handheld pipettes.
PCS Pipette Calibration System
Streamline pipette calibration, volume verification, and user assessment and training with this easy-to-use and affordable system for handheld pipettes.
Check out our other resources to learn more about ISO Standards and how Artel can help you comply
Get details on the latest 2022 revisions to ISO 8655, the new ISO 23783 series of standards for automated liquid handing instruments, and what they mean for your laboratory.
Hear how Dr. George Rodrigues explains what it means for your automated liquid handlers and pipettes.
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