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SOP for Operation of Dissolution Apparatus

OBJECTIVE 
To lay down the Operation procedure of dissolution test apparatus for better and error free use. 

SCOPE 
This procedure is applicable for all dissolution test apparatus apparatus installed in Quality Control Laboratory.


RESPONSIBILITY 
Execution : Chemist and above – QC department. 
Checking : Asst. Manager and above – QC department 

PROCEDURE 
  • Ensure that working bench and instrument is clean. 
  • Ensure that the instrument is calibrated. 
  • Switch on the mains power. 
  • Fill the bath with water up to the mark leveled. 
  • Switch on the instrument. 
  • When the power is on, the display shows previously set time, RPM and the temperature display shows the bath temperature. 
  • Place the lift jar filled with the medium according to the STP. 
  • Fix the paddle/basket according to the product STP. 
  • Press the temperature set switch and rotate the setting knob till digital display shows 37°C. 
  • Change the mode switch to RPM mode and switch on the motor. 
  • Using speed knob, adjust the RPM to required level and switch off the motor.
  • Press both Alarm and Reset switch so that Timer display shows 0.00. 
  • By pressing both Alarm and Slow or Alarm and Fast, set Alarm to the required time 
  • Allow the bath temperature instrument. 
  • After the test is completed the instrument will stop which is indicated by beep sound. 
  • Press the ↑ and ↓ keys to lift the stirrer unit. 
  • Take the required amount of the sample from the jars and clean. 
  • Switch OFF the instrument.

ABBREVIATION(s) 
SOP - Standard Operating Procedure 
Q.A - Quality Assurance 
Q.C - Quality control 
USP - United States Pharmacopoeia 

REVISION HISTORY
Nil

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