1.0 OBJECTIVE:
To lay down the procedure for calibration of pipettes, burettes and volumeteric flasks used in Quality control.2.0 SCOPE:
This SOP shall be applicable to Quality Control Dept.3.0 RESPONSIBILITY:
Quality Control Supervisor4.0 ACCOUNTABILITY:
Sr. Manager Quality Assurance5.0 PROCEDURE:
5.1 Graduated Pipettes:
Calibration of following types of graduated pipettes are 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 drop wise from 0.0 mark upto 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 drop wise 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 demineralised 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 drop wise from 0.0 mark upto 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 Volumeteric Flasks:
Volumeteric 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 demineralised water upto the mark. The weight of water filled flask is taken (W1). The capacity of the volumeteric 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 Procedure6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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