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SOP for Calibration of Halogen Moisture Analyzer


Standard operating procedure for Temperature Calibration and Balance Calibration of halogen moisture analyzer for result accuracy.

1.0  OBJECTIVE 

       To calibrate the equipment for reliable and accurate results.

2.0  SCOPE

       This procedure is applicable to Halogen moisture Analyzer, installed in quality control department.

3.0  RESPONSIBILITY

3.1  Doing      : Technical Assistant
3.2  Checking : Executive /Manager   

4.0  ACCOUNTABILITY

       Head of the Department

5.0  PROCEDURE

5.1  For the Temperature Calibration                         

5.1.1  Operate the instrument as per S.O.P.
5.1.2  Set the temperature 60°C by providing temperature key.   
5.1.3  Insert the calibrated thermometer of suitable range from top side to near temperature sensor.
5.1.4  After constant temperature achieved, observe the temperature in thermometer and record it in Annexure.
5.1.5  Same way set the temperature 105°C & 150°C & observe the temperature & record it in Annexure.

5.2  For Accuracy of Drying : 

5.2.1  Place approximately 0.2gm of water.
5.2.2  Start the instrument & observe the results.
5.2.3  Repeat the test two time again & record the observed result in Annexure.

5.3  For the Balance Calibration 

5.3.1  Press ‘MENU’ key & select w.cal :yes by ‘Ù’ or ‘Ú’ key  & enter by ←  key.
5.3.2  After few seconds w.cal : 50.000gm  will appear.
5.3.3  Open the sample chamber by pressing × key & remove the sample pan holder.  
5.3.4  Put calibrated 50gm weight. 
5.3.5  Wait till w.cal 0.000 appear, replace 50gm weight.    
5.3.6  Collect the printout of weight calibration & record the observation in Annexure.

5.4  For Accuracy of Balance

5.4.1  Remove the sample pan holder.
5.4.2  Place 1 gm weight & note the weight.   
5.4.3  Calculate the difference between the weight in certificate & observe the weight.     
5.4.4  Repeat the above steps using 2 gm & 5 gm weights.
5.4.5  Record the observed weight in Annexure.

5.5  For Precision

5.5.1  Place 500mg weight & note it.   
5.5.2  Repeat the above steps nine times.
5.5.3  Record the weight in Annexure.
5.5.4  Calculate the standard deviation   
5.5.5  Calculate the measurement uncertainity using the following equation. 


 =               3  x  SD                    
                  Actual weight from certificate 

5.6  Frequency  :

      Once in a three months.

6.0  ABBREVIATIONS

6.1  SD     = Standard deviation
6.2  gm.    = Gram
6.3  mg     = Milligram
6.4  Temp.= Temperature



ANNEXURE
QUALITY CONTROL DEPT.
CALIBRATION RECORD OF HALOGEN MOISTURE ANALYZER

CALIBRATION DATE

DATE OF LAST CALIBRATION
DONE
NEXT DUE FOR
CALIBRATION





INSTRUMENT DETAILS
INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.





OBSERVATION

(A)  Balance Calibration :
(1)  For Precision
Sr. No.
Theoretical weight
Actual weight from certificates
Observed weight
Measurement uncertainty
Tolerance
1




500 mg







Not more than 0.001
2

3

4

5

6

7

8

9

10

                                                                                                    SD=



OBSERVATION

(2)   For Accuracy :

Sr. No.
Internal
Calibration
With 50 gm
Nominal value of weight
Actual weight from certificate
Observed    weight
Tolerance
+0.2% at Actual weight
1
1 gm
2
2 gm
3
5gm
(B)    Temperature Calibration :
(1)   
Sr. No.
Setting Temperature 0C
Observed Temperature 0C
Tolerance 20C
1
60
2
105
3
150

(2)  Accuracy of Drying  :                 
Sr. No.
Taken weight of water in mg
% of water
Limit 100 + 2%
1
2
3

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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