SOP for Operation & Calibration of Dissolution Test Apparatus (VDA-8D)

OBJECTIVE

To lay down a Systematic procedure for the operation and calibration of the Dissolution Test Apparatus (Model: VDA-8D).

SCOPE

This SOP is a guideline for the operation and calibration of the Dissolution Test Apparatus (Model: VDA-8D).

RESPONSIBILITY

Q.C. Officer: To follow the procedure for operation of Dissolution Test Apparatus as per the SOP, as well as to carry out calibration of Dissolution Test Apparatus.

Q.C. In-charge: To check that the operation and calibration procedure ofthe  Dissolution Test Apparatus is being followed.

ACCOUNTABILITY

Head of the Department

PRE-CHECK

Ensure that the apparatus is clean and the plug is connected to the Electricity Supply.

OPERATING PROCEDURE

• By removing one of the vessels, fill the acrylic tank with distilled water up to the level mark. Then fit the dissolution vessel back in its place.
• Choose either six or eight stirring shafts with the blades or baskets as per the requirements of the test.
• Insert these shafts from the top plate of the instrument, which is having through hole and is marked as 2, 3, 4, 5 to the front row and 1, 8, 7, 6 to the second row.
• The stirrer shafts are marked as 1-2-3-4-5-6-7-8. Insert stirrer shaft no. 1 into spindle no. 1 of stirrer platform as so on.
• Fill the dissolution vessels with the dissolution media up to the mark, 900ml, or 1000ml or as per the requirement.
• This indicates that the temperature of the bath has reached 38℃. Still the test cannot be started as the temperature of the vessel yet to attain 37℃.
• The Stirrer Platform will automatically go down to its fixed position.
• Select ‘F1’ from the keyboard or select ‘Menu Start’ key from the instrument. Then select ‘TEST’.
• Select Operator Name, enter password, then select assembly type i.e. paddle type or basket type.
• Select the product whose test is to be carried out and press the ‘ENTER’ key twice.
• After the vessel reaches the set temperature, press the ‘ENTER’ key to start the machine.
• The machine will stop after it has travelled the set time.
• Use the ‘Platform Up’ and ‘Platform Down’ key from the keyboard for up and down movement of the Stirrer Platform.
• If necessary, Use ‘STR ON’ and ‘STR OFF’ key for the Stirrer on and off.
• For setting the parameters for a product

1. Press ‘F2’ key from the keyboard.
2. Enter ‘1, 2, 3, 4, 5, 6’ as the password.
3. Select the empty product. Enter all the required parameters (i.e. Product Name, Temperature, RPM, Alarm Time and Test Time) and press ‘ENTER’.
4. Go back to home page by pressing ‘Esc’ Key.
5. Carry out the test from the above point onward.

ALSO READ: SOP for Calibration of Dissolution Test Apparatus (Make: LAB INDIA)

• For Auto sampler

1. Press ‘Start’ key. The display show,

1. Select Synchronous and press ‘ENTER’.
2. The display shows Sample Vol. and Test No. Press any key to continue.
3. Enter the required sample volume.
4. Enter the required test no. (Test no. is the no. of Alarm set). Press ‘ENTER’ two times.
5. The display will show Select position to Start. Select Home position and then press enter. The test starts.

CALIBRATION

Temperature inside the vessel

• After the temperature has been attained to the defined limit, record the temperature of the medium at different time intervals (0, 10, 20 min.) with a calibrated thermometer.
• Compare the temperature of the calibrated thermometer with the set temperature.
• Limit (USP Specification): 37±0.5ºC.

Rotation of Stirring Shaft

• Set the rotation of the stirring shaft to 50, 75, 100 RPM as per the procedure defined.
• Use a Tachometer or manually count the number of rotations against time (per minute).
• Compare the observed rotation with the set rotation of the apparatus.
• Limit (USP Specification): 4% of set RPM i.e. 48 RPM – 52 RPM (if set RPM is 50).

Distance between the inside bottom of the vessel and the basket/paddle.

• Use a calibrated measuring scale to measure the distance between the inside bottom of the vessel and the basket/paddle.
• Place the measuring scale to the adjacent side of the basket/paddle and measure the distance between the basket/paddle and the bottom of the vessel.
• Limit (USP Specification): 25±2 mm.
• Record all the data.
• If it does not meet the limit, inform to the head of the department for the necessary corrective action.

Calibration Frequency: Quarterly

ABBREVIATIONS

SOP: Standard Operating Procedure

USP: United States Pharmacopeia

RPM: Revolution Per Minute

REFERENCES

User Manual, USP

ANNEXURE

Dissolution Test Apparatus Log Sheet

Dissolution Test Apparatus Calibration Report

REVISION HISTORY

Nil

ALSO READ: SOP for Operational Qualification of Dissolution Test Apparatus