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 Disintegration Test Apparatus for suppositories installed in 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 stabilise in the range of 36OCto 37OC. 
• Introduce one tablet, 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. 

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CALIBRATION PROCEDURE 

Frequency: Once in 3 months 

Operate the instrument as described above in operation procedure. 

Temperature Setting: 

 When indicator displays 37°C, measure the temperature of the bath with thermometer and record the results as per Annexure- 1

ABBREVIATION(s) 

SOP - Standard Operating Procedure 

Q.C - Quality control 

°C - Degree centigrade 

ANNEXURE(s) 

Annexure 1 - Calibration Record of Disintegration Test Apparatus. CLICK HERE

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