SOP for Calibration of Pipettes, Burettes and Volumetric Flasks Used in Quality Control : Pharmaceutical Guidelines

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SOP for Calibration of Pipettes, Burettes and Volumetric Flasks Used in Quality Control

Standard operating procedure to calibrate the volumeteric pipettes, burettes and volumeteric flasks used in quantitative analysis in quality control laboratory.

1.0 OBJECTIVE

To lay down the procedure for calibration of pipettes, burettes and volumetric flasks used in the Quality control.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Quality Control Supervisor

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 Graduated Pipettes

Calibration of following types of graduated pipettes is performed.
a) 1 ml b) 2 ml c) 5 ml d) 10 ml
Demineralised water is drawn in the pipette and the level of water is accurately adjusted at 0.0 mark. A small dry, empty beaker is placed on the balance and its tare weight (W0) is recorded. Gradually water is transferred dropwise from 0.0 mark up to 0.1 mark of the pipette, to the tared beaker, and its weight is recorded (W1). From the difference of weights (W1 – W0) the exact volume of water transferred by the pipette is calculated by the following formula:
               (W1 – W0)
V = ------------------------- (ml)
                0.99602
Where, 0.99602 is the density of water at 25°C
The pipettes are calibrated at other specified marks / positions as mentioned below.
1 ml pipette : 0.5 ml and 1.0 ml
2 ml pipette : 0.5 ml, 1.0 ml, 1.5 ml, 2.0 ml.
5 ml pipette : 1.0 ml, 2.0 ml, 3.0 ml, 4.0 ml, and 5.0 ml.
10 ml pipette : 2.0 ml, 4.0 ml, 6.0 ml, 8.0 ml and 10.0 ml.
Frequency of Calibration: At the time of receipt.

5.2 Volumetric Pipettes

Calibration of volumetric pipettes of following capacities are performed.
a) 1 ml b) 2 ml c) 5 ml d) 10 ml e) 20 ml f) 25 ml g) 50 ml
De-mineralized water is drawn in the pipette and the level of water is accurately adjusted at 0.0 mark. A small dry, empty beaker is placed on the balance and its tare weight (W0) is recorded. Gradually the whole amount of water is transferred dropwise from the mark of the pipette to the tared beaker, and its weight is recorded (W1). From the difference of weights (W1 – W0) the exact volume of water transferred by the pipette is calculated by the following formula:
                     (W1 – W0)
V = -------------------------------- (ml)
                       0.99602

Where, 0.99602 is the density of water at 25°C.
Frequency of Calibration: At the time of receipt.

5.3 Burettes

The burette is filled up to the mark with demineralized water and the level of water is accurately adjusted at 0.0 mark. A small dry, empty beaker is placed in the balance and its tare weight (W0) is recorded. Gradually water is transferred dropwise from 0.0 mark up to 0.05 mark of the burette, to the tared beaker, and its weight is recorded (W1). From the difference of weights (W1 – W0) the exact volume of water transferred by the burette is calculated by the following formula:
                  (W1 – W0)
V = --------------------------------- (ml)
                    0.99602

Where, 0.99602 is the density of water at 25°C.
The burette is calibrated at the following zones as mentioned below.
a) 0.0 – 1.0 ml b) 25.0 ml – 26.0 ml c) 49.0 ml – 50.0 ml
At each of the above zones calibration is carried out at the following marks/positions: i) 0.5 ml ii) 1.0 ml
The volume of water transferred each time from each of the above-mentioned zones are similarly calculated by the above formula.
Frequency of Calibration: at the time of receipt.

5.4 Volumetric Flasks

Volumetric flasks of following capacities are calibrated.
a) 100 ml b) 50 ml c) 25 ml d) 20 ml e) 10 ml
A clean and dry volumetric flask is taken and its weight is recorded (W0). The volumetric flask is then filled with demineralized water up to the mark. The weight of water filled flask is taken (W1). The capacity of the volumetric flask is calculated by the following formula:
                             (W1 – W0)
Capacity = --------------------------------- (ml)
                               0.99602

Where, 0.99602 is the density of water at 25°C.
Frequency of Calibration: At the time of receipt.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 Dept.: Department
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