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. 

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• 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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