1. Balances and Micropipettes By: Paola Restrepo and Ankita Desai

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

3. Validation Pre-purchase meeting with QA, users, and a member of Metrology 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. 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. 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. 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: 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, reviewed, and approved (meets all specifications), the balance may be release for GXP laboratory purposes. 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.

5. Calibration All of the calibration requirements (determined during the validation phase) are setup in the validated software database referred to as Calibration Manager. 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 The database information Includes the location of the equipment, user department, cost of unit, history (calibration, unscheduled repairs, etc.), scheduling, and calibration data references. 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. Calibration scheduling may include monthly, quarterly, and semiannual checks.

7. How its done? The monthly checks may require minimum and maximum weight checks. The monthly checks may require minimum and maximum weight checks. The monthly uncertainty is checked using the min weights. The monthly uncertainty is checked using the min weights. Additional maintenance is done as required. Additional maintenance is done as required. The semiannual calibration checks may involve the use of an approved outside vendor to perform calibrations and maintenance The semiannual calibration checks may involve the use of an approved outside vendor to perform calibrations and maintenance Includes lubing and thorough cleaning. Includes lubing and thorough cleaning.

8. Accuracy Accuracy Checks are done using calibrated Class 1 weights. Accuracy Checks are done using calibrated Class 1 weights. During Calibration During Calibration Min/Max +/- 0.1 % (measured vs. certified); Uncertainty +/- 0.1 % (repeat of 10 measurements of the min) Min/Max +/- 0.1 % (measured vs. certified); Uncertainty +/- 0.1 % (repeat of 10 measurements of the min) Daily Activities Daily Activities Min +/- 0.1 % (measured vs. certified) Min +/- 0.1 % (measured vs. certified)

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

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

12. Micropipettes Micropipettes are used to transfer small liquid volumes. Micropipettes are used to transfer small liquid volumes. It is used for more accurate and precise measurements of volumes smaller than 1ml. It is used for more accurate and precise measurements of volumes smaller than 1ml. It was invented in 1957 by Heinrich Schnitger in Germany. It was invented in 1957 by Heinrich Schnitger in Germany.

13. Micropipettes 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 1 st stop. Depress the plunger to 1 st 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 2 nd stop. Dispense the sample by pushing the plunger to the 2 nd stop. Withdraw the pipette and release the plunger. Withdraw the pipette and release the plunger. Discard the tip Discard the tip

14. Accuracy and precision Optimal range: 35% - 100% of volume Optimal range: 35% - 100% of volume Use a correct immersion angle. Pipette perpendicular to solution. Use a correct immersion angle. Pipette perpendicular to solution. Withdraw tip slowly and smoothly from liquid. Withdraw tip slowly and smoothly from liquid. Maintain controlled aspiration rates. Don’t let plunger snap back. Maintain controlled aspiration rates. Don’t let plunger snap back. Be consistent with pipetting rhythm, pressure on the plunger and speed. Be consistent with pipetting rhythm, pressure on the plunger and speed.

15. Micro Pipettes The pipettes are purchased based on the users preference. The pipettes are purchased based on the users preference. Solvay Pharmaceuticals typically purchases from Eppendorf. Solvay Pharmaceuticals typically purchases from Eppendorf. Standard pipettes are not validated (IQ/OQ) Standard pipettes are not validated (IQ/OQ) Calibrated on a semiannual basis Calibrated on a semiannual basis

16. Calibration Solvay’s calibration is currently done by Troemner Solvay’s calibration is currently done by Troemner Troemner has been audited and deemed as an acceptable vendor to calibrate them. 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). They do “As Found” (when received or as is) and “As Left” (after adjustments/maintenance).

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