SOP for Calibration of Infrared Moisture Balance : Pharmaceutical Guidelines

SOP for Calibration of Infrared Moisture Balance

Standard operating procedure to calibrate the infrared moisture balance comparing with LOD at 105 deg.C.

1.0  OBJECTIVE 


       To calibrate the equipment for reliable and accurate results.

2.0  SCOPE


       This procedure is applicable to infrared moisture balance, 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


       Frequency : Once in a three month


5.1  Operate the instrument as per SOP.

5.2  Set the temperature by ‘voltage regulator knob’.

5.3  After fifteen minute, observe the temperature and record it in annexure.
5.4  Select any raw material like starch or any inprocess granules sample. Carry out LOD at 105oC. Calculate and record % LOD in annexure-I
5.5  For same sample perform its LOD in the infrared moisture balance at the same temperature and record  the result in annexure.

5.6  The performance of the instrument is satisfactory if  the observed % L.O.D. difference between the oven and I.R.balance is within the tolerance limit of 10 % of  the % LOD observed in oven, otherwise follow the S.O.P.

6.0  ABBREVIATIONS


6.1  %  = Percentage

6.2  LOD = Loss on drying

6.3  I.R. = Infra red




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.
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