SOP for Calibration of Dissolution Test Apparatus

Learn how to write a standard procedure SOP for calibration of dissolution test apparatus in quality control laboratory in pharmaceuticals.

1. PURPOSE

To describe of this Standard Operating Procedure (SOP) is to provide a standardized process for the calibration of Dissolution Test Apparatus (DTA) to ensure accurate and reproducible test results in accordance with regulatory guidelines.

2. SCOPE

This SOP is applicable to all personnel involved in the calibration of the Dissolution Test Apparatus used to analysis in the laboratory. This includes both manual and automated apparatus.

3. RESPONSIBILITIES

3.1 Laboratory Personnel: Perform the calibration as per the outlined procedure and document results.

3.2 Quality Control (QC) Manager: Ensure the apparatus is calibrated at regular intervals and results are reviewed for compliance.

3.3 Maintenance Team: Provide technical support in case of any mechanical malfunctions during calibration.

4. ACCOUNTABILITY

Head of the Quality Assurance Department

5. ASSOCIATED DOCUMENTS / REFERENCES

5.1 USP Chapter <711> Dissolution

5.2 USP Chapter <1058> Analytical Instrument Qualification

5.3 ISO 9001 Quality Management Systems

6. PRECAUTIONS

6.1 Always wear appropriate Personal Protective Equipment (PPE) such as gloves, safety glasses, and lab coats when working with the dissolution apparatus.

6.2 Handle all chemicals and calibration standards according to their respective Material Safety Data Sheets (MSDS).

7. PROCEDURE

7.1 Apparatus and Materials

7.1.1 Dissolution Test Apparatus (USP Apparatus 1 or 2)

7.1.2 Calibration standards (e.g., Predetermined calibration tablets)

7.1.3 Thermometer with a valid calibration certificate

7.1.4 pH meter with valid calibration

7.1.5 Dissolution medium (e.g., simulated gastric fluid)

7.1.6 Stopwatch or timer

7.1.7 Calibration log book

7.1.8 Cleaning solutions (distilled water, ethanol, etc.)

7.1.9 Analytical balance (with valid calibration)

7.2 Pre-Calibration Preparations

7.2.1Ensure the dissolution apparatus is clean and in good working condition. Perform a visual inspection for any damaged or loose components.

7.2.2 Ensure that any connected pH meters, thermometers, or other devices are calibrated as per the manufacturer’s instructions.

7.2.3 Clean the apparatus thoroughly using appropriate cleaning agents and rinse with distilled water.

7.2.4 Prepare the dissolution medium according to the specifications outlined in the relevant pharmacopeial standards. Ensure the temperature of the medium is adjusted to the target temperature (usually 37°C ± 0.5°C).

7.3 Calibration of the Dissolution Apparatus

7.3.1 Place the dissolution vessel in the correct position in the apparatus and ensure that the shaft is aligned properly.

7.3.2 Check the stirring speed of the apparatus (50-100 rpm, depending on the apparatus type).

7.3.3 Verify that the dissolution vessels are level.

7.3.4 Use a standard dissolution tablet (e.g., BP, USP calibration tablets) for calibration purposes.

7.3.5 Place the tablet in the dissolution vessel and start the dissolution process.

7.3.6 Measure and record the temperature of the dissolution medium throughout the process. The temperature should remain constant at 37°C ± 0.5°C.

7.3.7 Record the pH of the dissolution medium at the appropriate intervals as required by the pharmacopeia.

7.3.8 Monitor the dissolution profile at pre-determined time intervals (e.g., 5, 10, 15, 30, 45, and 60 minutes).

7.3.9 Record the time taken for the tablet to dissolve completely or reach the desired dissolution endpoint.

7.3.10 Compare the dissolution data obtained from the standard calibration tablet with the acceptance criteria defined in the pharmacopeia (e.g., BP, USP standards).

7.3.11 The dissolution rate should match the expected results. Any discrepancies must be investigated and the apparatus recalibrated or serviced as necessary.

7.4 Post-Calibration Steps

7.4.1 After calibration, clean the dissolution vessels, paddles, and other components thoroughly with appropriate solvents and rinse with distilled water.

7.4.2 Record all calibration results in the calibration logbook.

7.4.3 Ensure that all data is documented with the date, time, operator name, and any anomalies or deviations.

7.4.4 Review the calibration results to ensure the apparatus is functioning within acceptable limits.

7.4.5 If the calibration results do not meet the specified limits, perform corrective actions such as re-calibration or maintenance of the apparatus.

7.5 Calibration Frequency

7.5.1 The dissolution apparatus must be calibrated at least once every six months or when there is a significant change in performance (e.g., after servicing or maintenance).

7.5.2 Additional calibration may be required if the equipment malfunctions or after significant environmental changes (e.g., temperature, humidity).

7.6 Documentation

7.6.1 All calibration results must be documented in the following formats:

7.6.2 Record the date, time, apparatus number, standard used, calibration results, and the signature of the person performing the calibration.

7.6.3 Record any deviations from the standard procedure and corrective actions taken.

7.7 Troubleshooting

7.7.1 Check for correct alignment of the dissolution vessel, stirring speed, and temperature control.

7.7.2 If the apparatus fails to maintain temperature or stirring speed, consult the maintenance manual or contact technical support for repairs.

8. DEFINITIONS AND ABBREVIATIONS

8.1 Dissolution Test Apparatus (DTA): An equipment used to measure the rate and extent to which the drug dissolves in a specified dissolution medium under controlled conditions.

8.2 Calibration: The process of verifying that an instrument is providing accurate and reliable results, typically by comparing it with a certified standard.

8.3 SOP: Standard Operating Procedure

8.4 MSDS: Material Safety Data Sheets

8.5 BP: British Pharmacopeia

8.6 USP: United States Pharmacopeia

8.7 QC: Quality Control

8.8 PPE: Personal Protective Equipment

9. ANNEXES

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

10. Revision History

Version	Date	Description of Change	Reviewed By	Approved By
1.0