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 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

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 the annexure.
5.4 Select any raw material like starch or any in-process granules sample. Carry out LOD at 105oC. Calculate and record % LOD in annexure-I
5.5 For the 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 the oven, otherwise follow the S.O.P.

6.0 ABBREVIATIONS

6.1 % = Percentage
6.2 LOD = Loss on drying
6.3 I.R. = Infrared





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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