1) SOP for Coating Process

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for the coating process of pharmaceutical products, including equipment setup, coating solution preparation, and parameters, to achieve uniform and stable coating.

3) Scope

This SOP applies to all personnel involved in the coating process within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for setting up, operating, and monitoring the coating equipment according to this SOP.
• Supervisors are responsible for overseeing the coating process and ensuring compliance.
• Quality Assurance (QA) personnel are responsible for verifying that procedures are followed correctly and addressing any deviations.

5) Procedure

1. Preparation
   1. Ensure the coating area is clean and free of contaminants.
   2. Verify the availability and quality of coating materials, including coating solution and tablets/capsules.
   3. Check the cleanliness and readiness of the coating equipment, including the coater.
2. Equipment Setup
   1. Set up the coating equipment according to the manufacturer’s instructions and the batch record.
   2. Install the coating pan and adjust the speed and angle as per the coating process parameters.
   3. Prepare the coating solution following the formulation and mixing instructions.
   4. Filter the coating solution to remove any particulate matter before use.
3. Coating Process
   1. Load the tablets or capsules into the coating pan according to the batch record.
   2. Start the coating process and adjust the spray rate and drying parameters (e.g., temperature, air flow) as per the batch record.
   3. Monitor the coating process continuously to ensure uniform coating coverage.
   4. Record coating parameters, such as spray rate, inlet air temperature, and process time, in the batch record.
4. Troubleshooting
   1. If the coating process deviates from the expected parameters or if quality issues arise, stop the operation immediately.
   2. Investigate the root cause of the issue and implement corrective actions.
   3. Document all deviations, investigations, and corrective actions in the appropriate records.
   4. Resume operation only after ensuring that the issue has been addressed and the coating process is back within acceptable limits.
5. Cleaning and Maintenance
   1. Turn off and clean the coating equipment thoroughly after each use.
   2. Use appropriate cleaning agents and procedures as specified in the cleaning SOP.
   3. Document the cleaning process and inspections in the cleaning logbook.
   4. Perform regular maintenance checks on the coating equipment and document them in the maintenance logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Batch Record
• Coating Solution Preparation Record
• Cleaning Logbook
• Maintenance Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual for the coating equipment

9) SOP Version

Version 1.0