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Balances and Micropipettes

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Users and Metrology will create or revise any SOPs (use/calibration). ... 100% of volume Use a correct immersion angle. Pipette perpendicular to solution. – PowerPoint PPT presentation

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Title: Balances and Micropipettes


1
Balances and Micropipettes
  • By Paola Restrepo and Ankita Desai

2
Balances
  • Types
  • Micro balances
  • Top Loaders
  • Analytical Balances
  • Floor Scales

3
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 determine whether 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.

4
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5
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.

6
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7
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.

8
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)

9
Weights
  • The weights are calibrated by a certified vendor.
  • Solvay sends their weights to Heusser Neweigh.

10
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11
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.

12
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.

13
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

14
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. Dont let
    plunger snap back.
  • Be consistent with pipetting rhythm, pressure on
    the plunger and speed.

15
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

16
Calibration
  • Solvays 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).

17
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18
References
  • http//us.mt.com/home
  • http//en.wikipedia.org/wiki/Micropipette
  • Solvay Pharmaceuticals
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