SOP for Operation of Electrolab Dissolution Apparatus

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

Execution: Chemist and above – QC department.

Checking: Asst. Manager and above – QC department

PROCEDURE

• Ensure that the 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 level.
• Switch on the instrument.
• When the power is on, the display shows the 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 the digital display shows 37°C.

ALSO READ: SOP for Calibration of Electrolab Dissolution Apparatus

• Change the mode switch to RPM mode and switch on the motor.
• Using a speed knob, adjust the RPM to the required level and switch off the motor.
• Press both the Alarm and Reset switch so that the 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 a beep sound.
• Press the ↑ and ↓ keys to lift the stirrer unit.
• Take the required amount of the sample from the jars and clean it.
• Switch OFF the instrument.

ABBREVIATION

SOP - Standard Operating Procedure

Q.A - Quality Assurance

Q.C - Quality control

USP - United States Pharmacopoeia

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: Relation between Assay and Dissolution Testing