Accuracy Matters Blog

Pipette Calibration Requirements for CAP Certified Laboratories

May 24, 2019 3:54:02 PM / by Kent Koeman

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As a trusted CAP Accredited laboratory, a lab manager or quality director is charged with the responsibility of maintaining all laboratory equipment according to CAP guidelines.  This post can help you learn what the College of American Pathologists requires for pipette calibration, and choose the best pipette service program for your needs.

WE’VE SEEN A THING OR TWO…

For more than 25 years, TTE Laboratories, an ISO Accredited independent pipette calibration lab,  has been working with CAP accredited laboratories all around the country.  The glaring truth is that the approach to equipment maintenance varies widely.   In our area of expertise of pipette calibration, we’ve observed that CAP labs, all under the same requirements, approach pipette calibration in many different ways. Some CAP labs do not service their instruments at all. In our opinion, pipette calibration services are often chosen on price and convenience as a first priority instead of fulfilling specific CAP requirements. We’re glad to let you know that there is a way to meet both needs!


WHAT ARE CAP REQUIREMENTS REGARDING PIPETTE CALIBRATION?

The answer is quite simple.

All laboratory equipment in a CAP Accredited lab should perform as the manufacturer intended.  

Pipettes should be serviced according to the manufacturer directions, use genuine manufacturer parts for replacement, and be tested (calibrated) to, and according to, their unique manufacturer test specifications.

As noted in the College of American Pathologists Laboratory Accreditation Manual,

“Calibration should be performed according to manufacturer instructions. Calibration or calibration verification must be performed every six months. If excessive time has elapsed between calibrations, a separate calibration verification process is required. (Laboratory Accreditation Manual, 2012 Edition, page 67).  Access the entire CAP Manual here


HOW ARE PIPETTES BEST CALIBRATED TO MEET STRICT MANUFACTURER SPECIFICATIONS?

There are more than 7 major manufacturers of pipettes and bottletop dispensers, in addition to several other smaller manufacturers. Each manufacturer might have several models, both manual and electronic, single channel and multi channel.  Each singular pipette model requires its own unique manufacturer test specifications, which often provide some of the tightest test tolerances in the industry.  Due to this challenge, the only acceptable method for calibrating pipettes to manufacturer specifications is a gravimetric test done with the correct methodology which reduces the test uncertainty to indiscernible levels.  This requires a calibration done using ISO:8655 test procedures, the definitive ISO procedure for pipette calibration.  A closer examination of these ISO 8655 procedures dictates that calibrations be done in a stable test environment which is controlled for temperature, humidity, and vibration; the three largest forces that affect the gravimetric test balances required for an ISO:8655 pipette calibration.  Conclusion: As a best practice, the CAP Certified lab needs pipette calibrations performed in a controlled lab that operates using ISO:8655 procedures.


HOW CAN WE SEND PIPETTES OFF-SITE FOR CALIBRATIONS WITHOUT INTERRUPTING THE LAB PROCESS ?

It is not only possible to send pipettes to the controlled lab, now it’s often preferred.  The industry is changing. Lab space has become expensive and congested. And onsite providers often are known for substandard work due to the limitations of their test equipment and parts replacement capabilities.  Companies are becoming less eager to host a calibration team in their lab space for any length of time.

In a competitive market, pipette calibration companies have developed their services to compete for your business, but only a select few are able to provide the calibration that a CAP lab requires.  Some providers deliver a high quality calibration, but service turnarounds are just too long, and costs are too high. The best vendors provide the best of both worlds: a high quality calibration that is easy to use, fairly priced, and of the highest quality.  Independent labs, such as TTE Laboratories Inc, have built a quality calibration process that is centered on the needs of the customer without sacrificing the quality process necessary to deliver an accurate calibration. Since calibrations performed in a controlled environment are required, these calibrations should be done with a quick turnaround (24 hours) to keep the lab functioning, and it should be easy and secure to send pipettes from any national location via common carrier (FedEx or UPS) using reusable protective packaging especially designed for pipettes.  Companies local to the calibration lab should be able to use a dedicated courier service that guarantees security and convenience.  


This type of service exists, and is available for every CAP Accredited Lab in the United States.

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Topics: ISO Calibration Services, Pipette Calibration, 17025, CAP

Kent Koeman

Written by Kent Koeman