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Standard Operating Procedure for Operating, Calibrating and Cleaning of Moisture Analyzer Balance used to determine the moisture content in bulk or granulated material during manufacturing of drug product.

Moisture Analyzer Balance

1.0   Objective :

• • To lay down the procedure for cleaning, operation and calibration of Moisture Analyzer Balance.

2.0   Scope :

• • This SOP is applicable in Manufacturing Area for cleaning, operation and calibration of Moisture Analyzer Balance.

3.0   Responsibility :

• • Operator : To follow the operation and cleaning procedure.

• • Production Chemist  : To check the operation and cleaning procedure.

• • QA : To Check and verify the operation and cleaning procedure.

4.0   Procedure for cleaning, operation and calibration of Moisture Analyzer Balance:

• • General Cleaning :

• • Ensure the cleaning of Moisture Analyzer Balance before start the operation.

• • Ensure that the main switch is off.

• • Open the lid and remove the disc and clean it properly with wet lint free cloth and followed by dry lint free cloth.

• • Clean the inside area and outer surface of the Moisture Analyzer Balance using dry lint free cloth.

• • After cleaning assemble the disc holder in draft shield.

• • Check the calibration due date.

• • To set the drying Parameters :

  • Switch ON the mains.

• • Switch ON the Moisture Analyzer Balance by pressing the button [] key.

• • Display will show 0.000g.

• • Select the temperature key and set the desired heating temperature by pressing up/down arrow key

• • Confirm heating temperature by pressing Enter key

• • Set the time parameter by selecting time key for the “end of analysis” where time is required. Where time is not defined operate the Moisture Analyzer Balance in Auto mode.

• • Confirm the “end of analysis” parameter by pressing Enter key.

• • Select the result display mode in %MC by pressing up/ down arrow keys.

• • Confirm the display mode by pressing Enter key.

• • Operating Procedure

• • After Turn ON the Moisture Analyzer, set the drying parameters.

• • Open the sample chamber and place an unused sample pan on the pan holder.

• • Tare the sample pan by pressing          0/T key

• • Distribute approx. (0.5 to 2.0 g sample) evenly on the sample pan and close the sample chamber.

• • For manual mode, press start key to start the drying & measuring process / for auto mode, there is no need to press start key. We use both modes as per requirement.

• • Current moisture loss and elapsed time are displayed on the screen and drying stops automatically with beep sound along with final print of result and displays End on the screen.

• • Clear the display.

• • Remove the sample pan carefully and clean it with tissue paper and again place the sample pan in the instrument.

• • Switch off the Moisture Analyzer Balance by pressing the button [ ] key

• • Clean the pan with tissue paper after cool.

• • Enter the details in Instrument log book.

• • Precaution:

• • Do not put the water, a metal pin or any other things in the instrument.

• • Do not open the Balance case.

• • Avoid to leave anything on the weighing pan after use.

• • Do not expose the balance to any type of magnetic field / air flow.

• • Do not exceed the maximum weight limit (71.0 g) for Model (depends upon the make & model of the instrument).

• • Check that power is supplied in advance for 1 hour for proper warm up of the balance

• Calibration of Moisture Analyzer Balance:

• • Balance Calibration by Weight

  • Calibration of Weighing System available in the Moisture Balance will be done by pressing Menu from the main board & selecting CAL by pressing up/down arrow keys.

• • Press Enter to confirm calibration.

• • The instrument tares, the weight icon are displayed and 50.000 g is flashing.

Related : Calibration of Analytical Balance

• • Place the requested test weight in the center of the sample pan holder.

• • The display flashes ——–.

• • Remove the test weight when 0.000 g is flashing.

• • The instrument displays successful adjustment with DONE and changes to weighing mode.

• • Note down the display reading with tolerance limit as given in Annexure- I, Calibration Record of Moisture Analyzer Balance.

• • Calibration of Moisture Analyzer Balance

• • Issue the required quantity of Di-sodium Tartrate from QC department.

• • Now add the material on pan approx. 2.0 g of Di-Sodium Tartrate.

• • Close the chamber and start the test.

• • Note down the display reading with tolerance limit as given in Annexure- I, Calibration Record of Moisture Analyzer.

• • Enter the details in Annexure-I

• • Prepare the calibration tag and affix it on the equipment.

• • Enclose the old calibration tag with the record and don’t throw it.

• • Frequency: one month ± 3 days.

• • If the variation is not within the specified tolerance limits, label the equipment with a tag, “OUT OF CALIBRATION” and inform to Department Head.

• • Do not use equipment until all errors are rectified. After rectification, again calibrate the equipment & record the observation.

• • Temperature of the Moisture Analyzer Balance will be calibrated by outside agency, once in a year.

5.0   Annexure :

Annexure I: Calibration Record of Moisture Analyzer Balance

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