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SOP for Calibration of Plunger Operated Pipette


Standard operating procedure to evaluate the performance of automatic plunger operated pipette.

1.0  Objective

       To calibrate the plunger operated pipette for reliable and accurate results.                                          

2.0  SCOPE

       This procedure is applicable to all plunger operated pipettes used in Q. C. department.

3.0  Responsibility 

3.1  Doing      : Technical Assistant
3.2  Checking : Executive /Manager

4.0  Accountability

       Head of the Department

5.0  Procedure

       Frequency  :Every six month

5.1  On receipt of plunger operated pipette, perform calibration of the same.
5.2  Before testing, condition the pipette by pipetting purified water for five times and discard pipette tip.
5.3  Mount a new pipette tip and rinse with the purified water.
5.4  Weigh the beaker having weight less than 4 gm on micro balance.
5.5  Withdraw three different volume (maximum, minimum and middle of the range) of purified water and pipette out in to dry beaker which is previously weighed.
5.6  Calibrate the pipette by wt/wt and convert to ml by using standard wt/ml at temperature of water at the time of calibration referring Annexure –II.
5.7  Repeat the above exercise for three times and record the results in Annexure-I.

5.7  Acceptance Criteria

For   20 µl
        50 µl                     =  + 0.7 %
        100 µl          
        200 µl
For  500 µl                    =  +  0.5%
       1000 µl

6.0  ABBREVIATIONS

6.1  SOP = Standard Operating Procedure
6.2  % = Percentage
6.3  gm = gram



ANNEXURE-I
Q. C. Department
CALIBRAITON OF PLUNGER OPERATED PIPETTE
1)  Adjustable Automated pipette :
Serial No.
: __________

Type

: __________
Trade Mark
: __________
Nominal Capacity
: __________

Subdivision :
2)  Damages                             :  None
                                                  :  Type of damage __________
3)  Testing condition                 : Temperature : __________°C
                                                     Balance Identification No         :
                                                     Thermometer Identification No.:
4)  Calculation                           :  V = W x Z
                                                     Where V  = Actual volume
                                                                W = Weight of filled water in gm
                                                                 Z = Factor in relation to temperature (Annexure II)
5)  Evaluation 
Min
Middle
Max
1
2
3
Mean
1
2
3
Mean
1
2
3
Mean
Measured volume  
Wt. of water
Volume of water
Tolerance


  • Calibration passed (within Tolerance limit)
  • Calibration not passed (not within Tolerance limits)
Calibration done By :_____________                          Checked By:______________
                                     (Sign & Date)                                                    Sign & Date)

                                                         ANNEXURE-II
                                                       Q. C. Department
                        CALIBRATION OF PLUNGER OPERATED PIPETTE
                                                    FACTOR "Z" [ml/g]
Medium atmospheric pressure range
1000 to 1020 hPa
Testing Temperature [oc]
Z [ml/g]
15
1.00202
15.5
1.00209
16
1.00216
16.5
1.00224
17
1.00232
17.5
1.00240
18
1.00248
18.5
1.00257
19
1.00266
19.5
1.00275
20
1.00285
20.5
1.00295
21.0
1.00305
21.5
1.00316
22
1.00323
22.5
1.00337
23
1.00348
23.5
1.00360
24
1.00371
24.5
1.00383
25
1.00395
25.5
1.00408
26
1.00420
26.5
1.00433
27
1.00446
27.5
1.00459
28
1.00473
28.5
1.00487
29
1.00501
29.5
1.00515
30
1.00529
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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