6/7/22, 4:57 PM SOP for Calibration of Halogen Moisture Analyzer : Pharmaceutical Guidelines

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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 the 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 uncertainty using the following equation.

= 2 x  SD
Actual weight from certificate

5.6 Frequency: Once in three months.

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

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6/7/22, 4:57 PM SOP for Calibration of Halogen Moisture Analyzer : Pharmaceutical Guidelines

QUALITY CONTROL DEPT.

CALIBRATION RECORD OF HALOGEN MOISTURE ANALYZER

CALIBRATION DATE DATE OF LAST CALIBRATION NEXT DUE FOR

DONE CALIBRATION

INSTRUMENT DETAILS
INSTRUMENT NAME INSTRUMENT MAKE INSTRUMENT
IDENTIFICATION NO.

OBSERVATION

(A)  Balance Calibration :

(1) For Precision

Sr. No. Theoretical Actual weight from Observed weight Measurement uncertainty Tolerance
weight certificates
1
2
3
4
5 500 mg Not more than
0.10
6
7
8
9
10
SD=

OBSERVATION

Sr. No. Internal Nominal value of Actual weight from Observed Tolerance
Calibration weight certificate weight +0.2% at Actual weight
With 50 gm

1 1 gm

2 2 gm

3 5gm

(B) Temperature Calibration :

(1)
0 0
Sr. No. Setting Temperature  C Observed Temperature  C 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

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6/7/22, 4:57 PM SOP for Calibration of Halogen Moisture Analyzer : Pharmaceutical Guidelines

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