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SOP for Calibration of Glassware in Pharmaceuticals


Standard operating procedure to calibrate the glassware used in quality control for analysis of Raw material and Finished products.

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.

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.  
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
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 & Reject those which does not pass in calibration. Destroy the rejected glassware immediately.
5.4  Calibrate the glass wares as per attached annexure. The value should fall with in the tolerance limits as mention in 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.
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 dry weighing vessel and record the weight.
5.6.2  Pipette water at approx 5 mm above the top mark using a pipeting 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.

Related: Calibration of Glassware (Class A and Class B)

5.7  For burette 

5.7.1  First take the weight of 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 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 time of calibration referring Annexure. 
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   oC    = Degree centigrade



ANNEXURE-I
Q. C. Department
 TESTING OF VOLUMETRIC INSTRUMENTS
FACTOR "Z" [ml/g]


Medium atmospheric pressure range 1000 to 1020 hPa
Testing
Temperature [oc]
Type of glass
Duran® Z [ml/g]
AR-Glas ® Z [ml/g]
15
1.00202
1.00211
15.5
1.00209
1.00217
16
1.00216
1.00223
16.5
1.00224
1.00230
17
1.00232
1.00237
17.5
1.00240
1.00245
18
1.00248
1.00252
18.5
1.00257
1.00260
19
1.00266
1.00268
19.5
1.00275
1.00277
20
1.00285
1.00285
20.5
1.00295
1.00294
21.0
1.00305
1.00303
21.5
1.00316
1.00313
22
1.00323
1.00320
22.5
1.00337
1.00333
23
1.00348
1.00343
23.5
1.00360
1.00354
24
1.00371
1.00364
24.5
1.00383
1.00375
25
1.00395
1.00386
25.5
1.00408
1.00398
26
1.00420
1.00410
26.5
1.00433
1.00422
27
1.00446
1.00434
27.5
1.00459
1.00447
28
1.00473
1.00459
28.5
1.00487
1.00472
29
1.00501
1.00485
29.5
1.00515
1.00499
30
1.00529
1.00512



VOLUMETRIC FLASKS: IS  915:1975
Nominal capacity, ml
5
10
25
50
100
250
500
1000
Tolerance,  ± ml
Class  A
0.02
0.02
0.03
0.04
0.06
0.1
0.15
0.2
Class  B
0.04
0.04
0.06
0.08
0.15
0.2
0.3
0.8
ONE-MARK PIPETTES : IS 1117:1975
Nominal capacity, ml
1
2
5
10
20
25
50
100
Tolerance,  ± ml
Class  A
0.01
0.01
0.02
0.02
0.03
0.03
0.04
0.06
Class  B
0.02
0.02
0.03
0.04
0.05
0.06
0.08
0.12
GRADUATED PIPETTES: IS 4162:1967
Nominal capacity, ml 1 2 5 10 25
Subdivision, ml 0.01 0.02 0.05 0.10 0.2
Tolerance,  ± ml
Class  A
0.006
0.01
0.03
0.05
0.1
Class  B
0.02
0.06
0.10
0.15
BURETTES: IS 1997:1967
Nominal capacity, ml 10 25 50 100
Subdivision, ml
0.05 0.05 0.1 0.1
Tolerance,  ± ml
Class  A
0.01
0.03
0.05
0.1
Class  B
0.02
0.06
0.1
0.2

Calibration passed (within tolerance limits)
Calibration not passed (Out of  tolerance  limits)
Date :                                       Analyst    __________        Checked by _________
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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