Operation and Maintenance of Tablet Coating Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet coating machine to ensure the production of coated tablets with uniform quality and appearance.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the tablet coating machine in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the tablet coating machine.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the coating process.
2. Verify the availability and integrity of tablets to be coated and the coating solution.
3. Inspect the tablet coating machine, including the pan and spray system, to ensure they are clean and calibrated.

4.2 Coating Process

1. Set up the coating parameters such as pan speed, inlet air temperature, and spray rate according to the coating recipe.
2. Load the tablets into the coating pan and start the coating process.
3. Gradually add the coating solution while maintaining the required process parameters.

4.3 Drying and Polishing

1. Continue the coating process until the tablets achieve the desired coating thickness.
2. Monitor the drying phase to ensure complete solvent evaporation and uniform coating adherence.
3. If required, polish the coated tablets to enhance their appearance and reduce sticking.

4.4 Cleaning and Maintenance

1. Stop the tablet coating machine after completing the coating batch.
2. Empty the coating pan and clean all contact surfaces thoroughly to remove residual coating material.
3. Perform routine maintenance tasks such as lubrication and inspection of machine parts.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Coating solution preparation record

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet coating machine

8) SOP Version

Version 1.0