The accurate, reliable, timely and regulatory-compliant calibration of pipettes is essential, especially for those customers who need to meet GMP or GLP regulations. Many of Histocom’s pipette calibration customers include scientists in clinical diagnostics laboratories who, for example, routinely perform tests on patient blood samples in order to identify certain diseases.
These tests involve adding reagents to samples in precise and minute volumes, often within the microlitre range. Inaccurate pipetting could lead to test-reaction failure or, even worse, false negative or false positive test results.
Similarly, Histocom’s customers, working within research environments, must be confident in their pipetting accuracy to generate reproducible and reliable results.
High Quality Service Needs Superior Equipment
The service engineers at Histocom use the gravimetric calibration technique, which is the most commonly used and accepted as the industry standard due to its accuracy. The service relies on two automated devices− METTLER TOLEDO’s XP26PC for single channel pipettes and MCP pipette calibration workstations for multichannel pipettes; both of which have been developed specifically for pipette calibration in accordance with ISO 8655 regulations.
These computerized, sensitive balances can determine the precise volume dispensed by a pipette in an extremely fast, easy and cost-effective way. Dispensed volumes are weighed for each pipette or pipette channel and these data are converted into volumes for further processing.
“We chose these instruments because they are the only available systems that have been fully validated for the applications.” explained Oliver Klenner, general manager at Histocom. “This gives us more confidence in our service quality and ensures that the process is as close to the industry standard requirements as possible.”
The complementary Calibry Software package guides the operator through each step of the procedure, providing comprehensive calibration history for each pipette channel and delivers a report of each process, meeting 21 CFR part 11 requirements.
“We use the XP26PC to calibrate single channel pipettes down to 1 μl nominal volume and the MCP for multichannel pipettes down to 10 μl nominal volume,” says Thomas Lienbacher, service engineer at Histocom. “With these automated instruments we can calibrate more pipettes each day. Calibrating a 12-channel pipette, for example, would normally require 360 measurements, but with the MCP we only have to take 30 measurements.”
The laboratory’s particularly rigorous calibration methods are important to many of its customers looking for validated and compliant procedures backed up with fully documented evidence. The XP26PC and MCP workstation are important tools for this service, providing regulatory compliant systems for measuring, capturing and storing essential data during each step of the calibration and helping to speed up and simplify the process.