SOP for Operation & Calibration of Disintegration Test Apparatus for Suppositories

OBJECTIVE

To lay down the procedure for operation and calibration of the Disintegration Test Apparatus for suppositories for better and error-free use.

SCOPE

This procedure is applicable for the Disintegration Test Apparatus for suppositories installed in the Quality Control Department.

RESPONSIBILITY

Execution: Chemist and above – QC department.

Checking: Asst. Manager and above – QC department

OPERATIONAL PROCEDURE

• Fill the acrylic tank with distilled water up to the water level mark. Keep the safety acrylic lid on the tank.
• Connect the instrument to Mains and put the MAIN switch ‘ON’. The red pilot lamp and four-line LCD display will come on.
• Set the temperature of the medium and allow it to stabilize in the range of 36°C to 37°C.
• Introduce one tablet, or capsule into each tube and if prescribed in the product’s monograph, add a disk to each tube.
• Suspend the assembly in the beaker and reset the timer to ‘00’, then switch on the motor.
• After the specified time switch off the motor and mains and remove the assembly from the liquid.

ALSO READ: SOP for Calibration of Disintegration Apparatus (Make: Electrolab)

CALIBRATION PROCEDURE

Frequency: Once in 3 months

• Operate the instrument as described above in the operation procedure.
• Temperature Setting: When the indicator displays 37°C, measure the temperature of the bath with a thermometer and record the results as per Annexure- 1

ABBREVIATION

SOP - Standard Operating Procedure

Q.C - Quality control

°C - Degree centigrade

ANNEXURE

Annexure-1: Calibration Record of Disintegration Test Apparatus.

REVISION HISTORY

Nil

ALSO READ: SOP for Operating Procedure of Disintegration Apparatus