Level 5 Accredited Pipette Calibration & Repair

ISO 17025:2005 As-Left Performance Analysis

Six Levels Service Guide | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Level 6 | Service at a Glance


Level 5 is an ISO/IEC 17025:2005 accredited service and is used by laboratories who must receive ISO 17025 accredited pipette calibrations, yet only require As-Left data. Level 5 Calibration Certificates document the environmental conditions present at the time of calibration, a statistical analysis of the instrument's performance, the process uncertainty associated with the calibration, and the final pass/fail status expressed in terms of imprecision, inaccuracy and K=2 confidence interval.

As part of our Level 5 service:


√ Parts are priced competitively at or below retail price and are subject to change.
√ Calibrate, Inc. will abide by any and all safety requirements of your company.
√ Calibrate, Inc. guarantees messages will be answered with a return call from a Calibrate, Inc. Service Representative within 48 hours of an inquiry.
√ Warranty Declaration for calibration, labor, and parts.

1. Pipette Identification:

Calibration reports are indexed by the serial number of the pipette, and/or by any additional identification codes (such as property tag numbers, or asset numbers) or by identifying markings found on the pipettes (such as initials or lab name). The next date for recommended service will be based on a semi-annual maintenance schedule unless otherwise specified by the client.

2. Preventative Maintenance and Accuracy Verification for Non-GMP/GLP Applications:
  • Complete disassembly (as applicable), inspection, and cleaning of instrument.
  • Replacement of Teflon seal and o-ring or grease, if the instrument requires a seal, and as recommended by the manufacturer.
  • Sticker affixed to pipette with information such as date of service and service provider, the serial number of the instrument, technician's initials, date of calibration, and next calibration due by month, day and year. Specific details concerning the information to be presented on the calibration label are determined with the customer during the contract review process.
  • Calibration of instrument to Calibrate, Inc.'s SOP 125–Level 5 specifications or to your unique calibration needs as defined by the contract review process.
  • Toll-Free Service Center telephone number and easy-to-use Service Ordering via our website.
  • All Measurement and Test Equipment used for calibration is SI through NIST traceable (copies of all NIST traceable Calibration Certificates are available upon request).
  • As-Left inaccuracy and imprecision data is provided for each pipette based upon the number of samples and volumes agreed upon during the contract review process. Calibrate, Inc. has a variety of validated templates designed to meet your verification needs.
  • Process uncertainty calculated for each calibration to determine if each test's results fall within the K=2 95% confidence interval.
  • Environmental conditions required for weight to volume calculation ascertained prior to each calibration event.

    3. Calibration Certificate:

    Calibrate, Inc. provides its Level 5 customers with a Calibration Certificate. This certificate provides valuable information concerning the pipette including: serial number; size; manufacturer; location; environmental conditions; and all the NIST traceability information concerning the Calibrate, Inc. Measurement and Test Equipment used in pipette calibration. Detailed As-Left Calibration Data is provided for each pipette serviced. Reference SOP 125–5.

    4. Failure Report:

    If a pipette cannot be repaired and/or fails to meet the required tolerances, the Calibration Certificate provided for that pipette will clearly indicate the failure. In addition, all failures are communicated personally to the customer. The end user must determine the disposition of the instrument.

    5. Measurement and Test Equipment Verification and Traceability:

    All Measurement and Test Equipment is calibrated by accredited third party vendors of calibration, and copies of NIST (SI) traceable Calibration Certificates are available upon request.

  • The balance is allowed to equilibrate to the customer's location, and then its performance is verified prior to use. (Reference Calibrate Inc. Quality Assurance Procedure 181.)
  • Only Class I NIST (SI) traceable weights, NIST (SI) traceable hygrometers, and NIST (SI) traceable Delta Range balances are used.

    6. Environmental Conditions:

  • Environmental conditions present in the customer's lab are entered into the Calibrate, Inc. proprietary software.
  • The program then calculates the air density, liquid density, and the Z factor from the values of barometric pressure, temperature, and relative humidity.
  • The Z factor is used to calculate the weight to volume conversion.
  • The inaccuracy and imprecision data is calculated from the volume values.

    7. Process Uncertainty:

    Process Uncertainty: Calibrate Inc.'s proprietary software calculates the process uncertainty of each test performed on client owned pipettes and the results are reported on the Calibration Certificate. The tolerances to which the pipette is calibrated are guard banded with the process uncertainty in order to determine pass/fail status. The process uncertainty formula and components are as follows:

  • Repeatability: Sample standard deviation of the replicate pipette measurements
    e.g., =stdev(range)

  • Resolution: number of decimal places divided by the square root of 12
    e.g., 0.0001/sqrt(12)

  • Combined Process Uncertainty:
    uc = √ repeatability2 + resolution2 + others...

  • Expanded Uncertainty (k=2 @ 95% Confidence Interval):
    U = 2 x uc

       
    8. Measurement Uncertainty:
  • All Calibrate, Inc. Calibration Service Department Personnel participate in monthly intra-laboratory proficiency testing (reference SOP 195 Measurement Assurance Program).
  • The results of the Intra-laboratory Proficiency Testing Program determine the company wide average uncertainty of measurement for pipette calibration and are published on our scope of accreditation to ISO 17025.

    Sample Certificates

    View a Sample Level 5 Certificate for Single Channel.
    View a Sample Level 5 Certificate for Multi Channel.




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