SOP for Operation of Dissolution Test Apparatus

Learn how to write a standard SOP for operation of dissolution test apparatus in the laboratory.

1. PURPOSE

To describes the process for the operation of the Dissolution Test Apparatus to ensure accurate and consistent dissolution testing of pharmaceutical dosage forms in accordance with pharmacopoeial standards

2. SCOPE

This SOP is applicable for all personnel involved in operating the dissolution test apparatus in the laboratory for pharmaceutical testing.

3. RESPONSIBILITIES

3.1 Executive/Officer/Analyst is responsible for operating the dissolution apparatus, following the procedure, and documenting results accurately.

3.2 Quality Control (QC) Manager is responsible to ensure that the dissolution test apparatus is calibrated and maintained according to regulatory requirements.

3.3 Maintenance Personnel is responsible for performing regular maintenance and ensuring the apparatus is in proper working condition.

4. ACCOUNTABILITY

Head of the Quality Control Department

5. ASSOCIATED DOCUMENTS / REFERENCES

5.1 USP Chapter <711> – Dissolution

5.2 BP (British Pharmacopoeia) – Dissolution Test Methods

5.3 IP (Indian Pharmacopoeia) – Dissolution Methods

5.4 Manufacturer’s User Manual for Model

5.5 SOP for Good Laboratory Practices (GLP)

6. PRECAUTIONS

6.1 After performing the test, clean-up of all used spare parts and its proper storage must be taken in careful consideration.

6.2 Handle all chemicals, including solvents, in accordance with Material Safety Data Sheets (MSDS).

6.3 Dispose of samples and solvents in accordance with laboratory safety protocols.

7. PROCEDURE

7.1 Pre-Operation Checks

7.1.1 Ensure that the dissolution test apparatus is calibrated as per the SOP for calibration of dissolution test apparatus and manufacturer’s specifications and regulatory requirements.

7.1.2 Calibration certificate for the apparatus should be available and up to date.

7.1.3 Ensure all apparatus components (e.g., vessels, paddles/baskets, motor) are clean, in good working condition, and securely positioned.

7.1.4 Ensure that the dissolution medium is freshly prepared or pre-warmed to the required temperature, and verify the pH (if applicable).

7.1.5 Add required dissolution media (volume as per procedure) on the six vessels individually.

7.2 Set Parameters

7.2.1 Switch on power button of machine.

7.2.2 Select the “Preset” mode.

7.2.3 Press “HEAT/ TEMP” button to preset temperature. For example 37.0°C set and then waits for few seconds.

7.2.4 Preset the rotation speed. For example 50 set and then wait for few seconds.

7.2.5 Preset the time. For example set 60 minutes set and then wait for few seconds.

7.3 Initiate the Test

7.3.1 Accurately place the dosage form (e.g., tablet or capsule) into each dissolution vessel at the specified position.

7.3.2 Ensure that no dosage form is in contact with the vessel wall or other dosage forms.

7.3.3 When actual temperature is match with required temperature then start the apparatus and allow the dissolution test to run for the specified duration.

7.3.4 Monitor the temperature, speed, and position of the dosage form during the test to ensure proper operation.

7.3.5 After complete the dissolution time, press off button for stop rotation.

7.4 Sampling:

7.4.1 At specified intervals (e.g., every 5, 10, 15, or 30 minutes), use the sampling device to withdraw a specified volume of the dissolution medium.

7.4.2 Filter the sample (if necessary) and prepare for analysis.

7.5 Post-Test Procedure:

7.5.1 Once the test is completed, stop the apparatus and remove the vessels.

7.5.2 Properly dispose of or store the dissolution medium as per the laboratory’s waste disposal guidelines.

7.6 Cleaning

7.6.1 Remove the paddle or baskets from the stands.

7.6.2 Wash the stands with purified water by squib bottles.

7.6.3 Discard the dissolution media on the vessels.

7.6.4 Wash the vessel by tape water and finally rinse the vessels with purified water.

7.6.5 Replace the vessels on the machine.

7.6.6 Wipe the rods with soft duster or tissues.

7.6.6 Wash the paddles or baskets with tape water and finally rinse with purified water.

7.6.7 Put the paddles or baskets in oven (105°C) for drying.

7.6.8 Keep the machine ready for next operation.

7.6.9 Fill up the log book after operation.

7.7 Troubleshooting

7.7.1 If the apparatus fails to meet expected performance, refer to the troubleshooting guide in the operator’s manual for the specific model. Report any unresolved issues to the maintenance team

7.7.2 Common issues may include:

Incorrect rotation speed

Temperature deviations

Vibration or instability in the apparatus

Issues with the motor or paddle/basket

8. ABBREVIATIONS / DEFINITIONS

8.1 Dissolution Test: A laboratory procedure used to measure the rate at which a drug is released from its dosage form into a given dissolution medium under controlled conditions.

8.2 Dissolution Apparatus: The equipment used to perform dissolution testing.

8.3 SOP: Standard Operating Procedure

8.4 QC: Quality Control

8.5 MSDS: Material Safety Data Sheets

8.6 USP: United States Pharmacopoeia

9. ANNEXES

9.1 Annex-1: Log Book for Operation of Dissolution Test Apparatus

10. Revision History

Version	Date	Description of Change	Reviewed By	Approved By
1.0