When the time comes to have your pipettes calibrated, it’s important to know which of the many service providers and calibration levels is right for you. Regulatory compliance needs vary greatly throughout the market, but all labs want a sound, reliable service provider. The good news is, regardless of what your level of calibration compliance, TTE Laboratories provides 5 pipette calibration options; each level includes complete preventative maintenance and repair. Whether an academic lab requiring the basic needs of our level 1 calibration level, or a regulated lab requiring the standardized compliance of our ISO accredited calibration level, we provide a complete service with each calibration level. TTE Laboratories will disassemble, clean, repair and perform a detailed preventative maintenance on every pipette that comes into our lab, all at no extra cost. Each of our pipette calibration levels ensure that your pipettes are TTE-certified, performing to tolerance and functioning “like-new.” You will see and feel the difference.
There are five available levels of calibration: levels 1-4 and ISO. In this blog post, we will explain how each level can help you meet a certain market compliance requirement. This information will help you determine which level of calibration will suit the needs of your laboratory.
Levels 1-2: These calibration levels are intended to provide customers with a TTE certificate of compliance and traceability, a calibration label, and validation of each pipette’s performance. Pipettes calibrated to level 1 service do not provide measurement data, but instead state that pipettes are compliant to a manufacturer’s tolerance specifications. Level 1 and 2 services both include a complete pm and repair service, with four “as left” measurements from each test volume. Level 2 calibration certificates report “as left” measurement data, along with a calculated “PASS/FAIL” result.
- Who needs Levels 1-2? Academic and research laboratories provide basic scientific development and testing. Since much of their process has yet to be standardized or regulated, TTE’s level 1 and level 2 calibrations provide the necessary service and measurement information.
Levels 3-4: Calibration services at these levels provide traceable, compliance-oriented certificates that include both “as found” and “as left” measurements and. “As found” test measurements reflect pipette performance prior to TTE’s service, while “as left” data reflects performance following TTE’s pipette service. Included in both is a complete pm and repair service. Level 3 calibrations provide four measurements at all test volumes and Level 4 calibrations provide four “as found” measurements, but 10 “as left” measurements for each test volume.
- Who needs levels 3-4? In the U.S., laboratories that develop, produce, and test drugs and therapeutics are regulated by the FDA. Clinical testing labs that provide diagnostic test information are regulated by CLIA and CAP. As a result, compliance to cGMP and cGLP standards and other regulatory requirements is critical, even ensured by periodic site audits from these agencies. TTE’s level 3 and 4 services provide the fundamental compliance point to meet the requirements of these government agencies.
ISO Level: Calibration service at the ISO accreditation level provides a calibration service with strict adherence to ISO 17025 and ISO 8655 standards. ISO 8655 requires 10 measurements from each test volume and that those test volumes represent 10, 50, and 100% of a pipette’s maximum measurement volume. Also required are the allowable limits of both systematic (accuracy) and random (precision) test error and the environmental conditions with which to determine that information. ISO level calibrations provide no less than 10 measurements for all “as found” and “as left” testing.
- Who needs ISO level? ISO accredited laboratories and the most strictly regulated test laboratories will ensure compliance with TTE’s ISO calibration level. Companies may also choose ISO level calibration to maximum risk mitigation during FDA audits.
Regardless of the level of compliance needed, TTE provides a complete calibration, cleaning, repair, and preventative maintenance. Why? Because a complete, full-service calibration program can provide the highest levels of regulatory compliance, while minimizing the risk of pipette failure. It is what separates us from other calibration companies. TTE calibration services are performed with only highest methodology standards, validated competence and the right test equipment, to provide the most accurate and precise pipette measurement results.