STANDARD OPERATING PROCEDURE OPERATION AND MAINTENANCE OF DISSOLUTION TEST APPARATUS (TDT-06 P)

STANDARD OPERATING PROCEDURE

SUBJECT :                     OPERATION AND MAINTENANCE OF DISSOLUTION TEST APPARATUS (TDT-06 P)

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

           

To provide guidelines for operation and Maintenance of Dissolution Test apparatus.

2.0       POLICY:  

                       

Dissolution test apparatus is used for testing the dissolution profile of tablets so it is necessary to maintain it in orderly condition and to check its performance.

3.0       PROCEDURE:

3.1       Switch on the power.

3.2       After the power is on the instrument will be initialized and the display will show start indicating the manual mode of operation.

3.3       Switch on the Heat switch provided on the rear right hand side of the stirrer unit.

3.4       After the power is switched the following are displayed.

3.4.1    The STEP and TIMER display shows “Start”.

3.4.2    The RPM display shows “000”.

3.4.3    The temperature display shows the present temperature of the water bath.

3.5       Lift the stirrer unit using the LIFT SWITCH provided at the rear right hand side.

3.6       Place the test jars filled with the medium in the bath.

3.7       Fix the paddle or baskets as desired for the test.

3.8       Now set the desired temperature. Press and hold the push button switch and turn the set temperature knob in clockwise / counter clockwise direction and lock the knob after setting is completed.

3.9       Now set the desired RPM by turning the SET RPM knob in clockwise / counter clockwise direction and lock it. Now set the time parameter by the computerized panel.

3.10     Test time is the cumulative time of all steps programmed in that test. While setting the step timing makes sure that the current step time is more than the previous step time. If the step timing is not entered correctly then the tm-Err will be displayed.

3.11     To set time enter step and set the time in minutes and hours with the help of arrow switches to increase and decrease. After the time is set check the temperature of the medium in the bowls.

3.12     Place one tablet inside the test bowl.

3.13     Bring the stirrer unit down using the lift switch. The stirrer unit will automatically stop.

3.14     Start the test by pressing the Run / Halt key.

3.15     At the end of the run time the buzzer beeps for a few seconds.

3.16     At the end of the specified time collect the medium from each bowl and test as per the specified test procedure.

3.17     After completion of testing ensure that the bowls and paddles are cleaned thoroughly.

3.18     CALIBRATION: Check the temperature of the water bath with a calibrated thermometer and check the RPM of the paddle once in 3 months.

4.0       FREQUENCY OF USE:  Use as and when required.

5.0       RESPONSIBILITY: Executive QA & Chemist QA.

6.0       REVIEW GUIDE: Calibration register.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x