SOP for Calibration of Glassware in Pharmaceuticals
1.0 Objective
To ensure that the glassware used for analysis is accurate and is within the tolerance limits of nominal volume.
2.0 Scope
This procedure is applicable for all glassware (Burette, pipette & volumetric flask) to be used in quality control laboratory.
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3.0 Responsibility
3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Manager
4.0 Accountability
Head of the Department
5.0 Procedure
5.1.1 Clean the glassware & make it free from grease before carrying out calibration.
5.1.2 Clean the wet outer surface with tissue paper.
5.1.3 Before calibration keep all glassware at room temp for 1 hrs.
5.1.4 The glassware must not be wetted above the meniscus, if this happens, wipe it with tissue paper.
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5.1.5 Always kept your eye at the same level, while aligning the meniscus.
5.2 On receipt of glassware from the supplier, enter detail into the inward register with following details.
a. Date of receipt
b. Description
c. Serial No.
d. Quantity received
e. Supplier Name
f. Challan No.
g. Qty.Approved/Serial No.
h. Qty.rejected/Serial No.
i. Remark
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5.3 On receipt of glassware allot serial no. as per point 5.11 and then calibrate it and accept only those glassware which passes in calibration & rejects those which does not pass in calibration. Destroy the rejected glassware immediately.
5.4 Calibrate the glassware as per attached Annexure. The value should fall within the tolerance limits as mention in the annexure.
5.5 For volumetric flask
N.B. : This is applicable up to 100 ml volumetric flask.
5.5.1 First take the empty weight of dry volumetric flask and record the weight.
5.5.2 Fill it with distilled water through funnel 5 mm below the ring mark.
5.5.3 Adjust the meniscus precisely to the ring mark by adding water dropwise with a pipette.
5.5.4 In case of volume exceed the marking, remove it with help of tissue paper or pipette.
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5.5.5 Measure the weight of the filled volumetric flask and record the weight.
5.6 For pipette
5.6.1 First take the weight of the dry weighing vessel and record the weight.
5.6.2 Pipette water at approx 5 mm above the top mark using a pipetting aid.
5.6.3 Adjust the meniscus precisely by discharging the excess water.
5.6.4 Allow the water to run off into the weighing vessel. So as to touch the pipette tip to the inclined wall of the vessel.
5.6.5 Wait for few seconds and measure the weight of vessel & record it.
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5.7 For burette
5.7.1 First take the weight of the dry weighing vessel and record the weight.
5.7.2 Clamp the burette vertically.
5.7.3 Fill the burette to approx 5 mm above the zero mark
5.7.4 Remove any air bubble from burette & also from stop cork.
5.7.5 Set the zero precisely by releasing liquid.
5.7.6 Run off the water from burette as per requirement
5.7.7 Ensure that burette tip shall not touch the wall of the vessel.
5.7.8 Wait for few seconds and measure the weight of the vessel and record it.
5.8 Calibrate the glassware by wt/wt and convert to ml using std wt/ml at temp of water at the time of calibration referring Annexure.
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5.9 Record all values & finding and for graduated pipettes Annexure.
5.10 All values and findings of graduated pipette and Burette in Annexure.
5.11 Allot Serial no. for each range of glassware before calibration as follows.
YAX
Y = Type of glassware to be calibrated
V = Volumetric flask
P = Pipette
G = Graduated pipette
B = Burette:
A = Corresponds to year in which glassware calibrated (i.e. 0,1,2,3)
X = Is series starting from 1.
6.0 Abbreviations
6.1 wt/wt = weight by weight
6.2 Wt/ml = weight per mililiter
6.3 I.P. = Indian pharmacopoeia
6.4 °C = Degree centigrade
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