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Balances and Micropipettes. By: Paola Restrepo and Ankita Desai. Balances. Types Micro balances Top Loaders Analytical Balances Floor Scales. Validation. Pre-purchase meeting with QA, users, and a member of Metrology

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balances and micropipettes

Balances and Micropipettes

By: Paola Restrepo and Ankita Desai

balances
Balances
  • Types
    • Micro balances
    • Top Loaders
    • Analytical Balances
    • Floor Scales
validation
Validation
  • Pre-purchase meeting with QA, users, and a member of Metrology
    • Discuss the user requirements and the suitability of the proposed balance to be purchased.
  • The Lab Strategy form is completed once the equipment arrives to determinewhether it will be used for GXP purposes.
  • If the unit is to be validated, protocols are drafted, reviewed and approved by the user and the validation team. Example of protocols include the Installation Qualification and Operational Qualification.
    • Additional task include:
      • The calibration/maintenance requirements to be performed periodically.
      • Users and Metrology will create or revise any SOPs (use/calibration).
  • Once all of the pertinent documents and tasks are executed, reviewed, and approved (meets all specifications), the balance may be release for GXP laboratory purposes.
calibration
Calibration
  • All of the calibration requirements (determined during the validation phase) are setup in the validated software database referred to as Calibration Manager.
  • The database information
    • Includes the location of the equipment, user department, cost of unit, history (calibration, unscheduled repairs, etc.), scheduling, and calibration data references.
  • Calibration scheduling may include monthly, quarterly, and semiannual checks.
how its done
How its done?
  • The monthly checks may require minimum and maximum weight checks.
  • The monthly uncertainty is checked using the min weights.
  • Additional maintenance is done as required.
  • The semiannual calibration checks may involve the use of an approved outside vendor to perform calibrations and maintenance
    • Includes lubing and thorough cleaning.
accuracy
Accuracy
  • Accuracy Checks are done using calibrated Class 1 weights.
  • During Calibration
    • Min/Max +/- 0.1 % (measured vs. certified); Uncertainty +/- 0.1 % (repeat of 10 measurements of the min)
  • Daily Activities
    • Min +/- 0.1 % (measured vs. certified)
weights
Weights
  • The weights are calibrated by a certified vendor.
  • Solvay sends their weights to Heusser Neweigh.
daily use
Daily Use
  • Users perform daily checks using the minimum weight accepted on the balance. This is required before the balance may be used for any GXP purposes that day.
  • The daily accuracy specification is the certified minimum weight vs. the measured minimum weight +/- 0.1 % of the weight.
  • The daily checks along with any other entries such as the material to be weighed are recorded in the logbook.
  • The logbook is cross referenced with the lab notebook.
micropipettes
Micropipettes
  • Micropipettes are used to transfer small liquid volumes.
  • It is used for more accurate and precise measurements of volumes smaller than 1ml.
  • It was invented in 1957 by Heinrich Schnitger in Germany.
micropipettes13
Micropipettes
  • Micropipettes have 3 positions:
    • Rest position.
    • First stop.
    • Second stop.
  • How to use it :
    • Set volume.
    • Attach disposable tip.
    • Depress the plunger to 1st stop.
    • Immerse tip in sample and Draw up sample.
    • Withdraw the tip.
    • Dispense the sample by pushing the plunger to the 2nd stop.
    • Withdraw the pipette and release the plunger.
    • Discard the tip
accuracy and precision
Accuracy and precision
  • Optimal range: 35% - 100% of volume
  • Use a correct immersion angle. Pipette perpendicular to solution.
  • Withdraw tip slowly and smoothly from liquid.
  • Maintain controlled aspiration rates. Don’t let plunger snap back.
  • Be consistent with pipetting rhythm, pressure on the plunger and speed.
micro pipettes
Micro Pipettes
  • The pipettes are purchased based on the users preference.
  • Solvay Pharmaceuticals typically purchases from Eppendorf.
  • Standard pipettes are not validated (IQ/OQ)
  • Calibrated on a semiannual basis
calibration16
Calibration
  • Solvay’s calibration is currently done by Troemner
  • Troemner has been audited and deemed as an acceptable vendor to calibrate them.
  • They do “As Found” (when received or as is) and “As Left” (after adjustments/maintenance).
references
References:
  • http://us.mt.com/home
  • http://en.wikipedia.org/wiki/Micropipette
  • Solvay Pharmaceuticals