1) SOP for Operating Capsule Polishing Machines

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating capsule polishing machines, including setup, cleaning, and maintenance, to ensure that capsules are polished and free of excess powder and debris.

3) Scope

This SOP applies to all personnel involved in the operation of capsule polishing machines within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for setting up, operating, and cleaning capsule polishing machines according to this SOP.
• Supervisors are responsible for overseeing the polishing 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 capsule polishing area is clean and free of contaminants.
   2. Verify the availability of filled capsules and cleaning materials as per the batch record.
   3. Check the cleanliness and readiness of the capsule polishing machine.
2. Equipment Setup
   1. Assemble the capsule polishing machine according to the manufacturer’s instructions.
   2. Verify that all components are securely in place and properly aligned.
   3. Set the machine parameters (e.g., polishing speed, time) according to the batch record.
3. Polishing Process
   1. Load the filled capsules into the polishing machine.
   2. Start the machine and monitor the polishing process continuously.
   3. Ensure that the capsules are polished uniformly and free of excess powder and debris.
   4. Adjust the machine settings if necessary to maintain consistency.
   5. Document any observations and adjustments made during the polishing process.
4. Inspection
   1. After polishing, inspect the capsules to ensure they meet the quality standards.
   2. Segregate any capsules that do not meet the standards and document the findings.
5. Cleaning and Maintenance
   1. Turn off and disassemble the capsule polishing machine according to the manufacturer’s instructions.
   2. Clean all parts thoroughly to prevent cross-contamination.
   3. Document the cleaning process in the cleaning logbook.
   4. Perform regular maintenance checks and document them in the maintenance logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Batch Record
• Cleaning Logbook
• Maintenance Logbook

8) Reference, if any

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

9) SOP Version

Version 1.0