Balances and Balances and MicropipettesMicropipettes

By: Paola Restrepo and Ankita By: Paola Restrepo and Ankita DesaiDesai

BalancesBalances

TypesTypes Micro balancesMicro balances Top LoadersTop Loaders Analytical BalancesAnalytical Balances Floor ScalesFloor Scales

ValidationValidation Pre-purchase meeting with QA, users, and a member of Pre-purchase meeting with QA, users, and a member of

MetrologyMetrology Discuss the user requirements and the suitability of the proposed Discuss the user requirements and the suitability of the proposed

balance to be purchased.balance to be purchased.

The Lab Strategy form is completed once the equipment arrives The Lab Strategy form is completed once the equipment arrives to determineto determine whether it will be used for GXP purposes. whether it will be used for GXP purposes.

If the unit is to be validated, protocols are drafted, reviewed and If the unit is to be validated, protocols are drafted, reviewed and approved by the user and the validation team. Example of approved by the user and the validation team. Example of protocols include the Installation Qualification and Operational protocols include the Installation Qualification and Operational Qualification. Qualification. Additional task include:Additional task include:

The calibration/maintenance requirements to be performed periodically.The calibration/maintenance requirements to be performed periodically. Users and Metrology will create or revise any SOPs (use/calibration). Users and Metrology will create or revise any SOPs (use/calibration).

Once all of the pertinent documents and tasks are executed, Once all of the pertinent documents and tasks are executed, reviewed, and approved (meets all specifications), the balance reviewed, and approved (meets all specifications), the balance may be release for GXP laboratory purposes. may be release for GXP laboratory purposes.

CalibrationCalibration

All of the calibration requirements All of the calibration requirements (determined during the validation phase) are (determined during the validation phase) are setup in the validated software database setup in the validated software database referred to as Calibration Manager. referred to as Calibration Manager.

The database information The database information Includes the location of the equipment, user Includes the location of the equipment, user

department, cost of unit, history (calibration, department, cost of unit, history (calibration, unscheduled repairs, etc.), scheduling, and unscheduled repairs, etc.), scheduling, and calibration data references.calibration data references.

Calibration scheduling may include monthly, Calibration scheduling may include monthly, quarterly, and semiannual checks. quarterly, and semiannual checks.

How its done?How its done?

The monthly checks may require minimum The monthly checks may require minimum and maximum weight checks. and maximum weight checks.

The monthly uncertainty is checked using The monthly uncertainty is checked using the min weights.the min weights.

Additional maintenance is done as required. Additional maintenance is done as required. The semiannual calibration checks may The semiannual calibration checks may

involve the use of an approved outside involve the use of an approved outside vendor to perform calibrations and vendor to perform calibrations and maintenance maintenance Includes lubing and thorough cleaning.Includes lubing and thorough cleaning.

AccuracyAccuracy

Accuracy Checks are done using Accuracy Checks are done using calibrated Class 1 weights.calibrated Class 1 weights.

During Calibration During Calibration Min/Max +/- 0.1 % (measured vs. Min/Max +/- 0.1 % (measured vs.

certified); Uncertainty +/- 0.1 % (repeat certified); Uncertainty +/- 0.1 % (repeat of 10 measurements of the min)of 10 measurements of the min)

Daily ActivitiesDaily Activities Min +/- 0.1 % (measured vs. certified) Min +/- 0.1 % (measured vs. certified)

WeightsWeights

The weights are calibrated by a The weights are calibrated by a certified vendor. certified vendor.

Solvay sends their weights to Solvay sends their weights to Heusser Neweigh.Heusser Neweigh.

Daily UseDaily Use Users perform daily checks using the Users perform daily checks using the

minimum weight accepted on the balance. minimum weight accepted on the balance. This is required before the balance may be This is required before the balance may be used for any GXP purposes that day.used for any GXP purposes that day.

The daily accuracy specification is the The daily accuracy specification is the certified minimum weight vs. the measured certified minimum weight vs. the measured minimum weight +/- 0.1 % of the weight.minimum weight +/- 0.1 % of the weight.

The daily checks along with any other The daily checks along with any other entries such as the material to be weighed entries such as the material to be weighed are recorded in the logbook. are recorded in the logbook.

The logbook is cross referenced with the lab The logbook is cross referenced with the lab notebook. notebook.

MicropipettesMicropipettes

Micropipettes are used to transfer Micropipettes are used to transfer small liquid volumes.small liquid volumes.

It is used for more accurate and It is used for more accurate and precise measurements of volumes precise measurements of volumes smaller than 1ml.smaller than 1ml.

It was invented in 1957 by Heinrich It was invented in 1957 by Heinrich Schnitger in Germany.Schnitger in Germany.

MicropipettesMicropipettes Micropipettes have 3 positions:Micropipettes have 3 positions:

Rest position.Rest position. First stop. First stop. Second stop.Second stop.

How to use it :How to use it : Set volume.Set volume. Attach disposable tip.Attach disposable tip. Depress the plunger to 1Depress the plunger to 1stst stop. stop. Immerse tip in sample and Draw up sample.Immerse tip in sample and Draw up sample. Withdraw the tip.Withdraw the tip. Dispense the sample by pushing the plunger to the 2Dispense the sample by pushing the plunger to the 2ndnd stop. stop. Withdraw the pipette and release the plunger.Withdraw the pipette and release the plunger. Discard the tipDiscard the tip

Accuracy and precisionAccuracy and precision

Optimal range: 35% - 100% of volumeOptimal range: 35% - 100% of volume Use a correct immersion angle. Pipette Use a correct immersion angle. Pipette

perpendicular to solution.perpendicular to solution. Withdraw tip slowly and smoothly from Withdraw tip slowly and smoothly from

liquid.liquid. Maintain controlled aspiration rates. Maintain controlled aspiration rates.

Don’t let plunger snap back.Don’t let plunger snap back. Be consistent with pipetting rhythm, Be consistent with pipetting rhythm,

pressure on the plunger and speed. pressure on the plunger and speed.

Micro Pipettes Micro Pipettes

The pipettes are purchased based on The pipettes are purchased based on the users preference. the users preference.

Solvay Pharmaceuticals typically Solvay Pharmaceuticals typically purchases from Eppendorf. purchases from Eppendorf.

Standard pipettes are not validated Standard pipettes are not validated (IQ/OQ)(IQ/OQ)

Calibrated on a semiannual basis Calibrated on a semiannual basis

CalibrationCalibration

Solvay’s calibration is currently done Solvay’s calibration is currently done by by Troemner Troemner

Troemner has been audited and Troemner has been audited and deemed as an acceptable vendor to deemed as an acceptable vendor to calibrate them.calibrate them.

They do “As Found” (when received They do “As Found” (when received or as is) and “As Left” (after or as is) and “As Left” (after adjustments/maintenance). adjustments/maintenance).

References:References:

http://us.mt.com/home http://en.wikipedia.org/wiki/Micropipe

tte Solvay Pharmaceuticals Solvay Pharmaceuticals