1) SOP for Operating Capsule Filling Machines

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for operating capsule filling machines, including setup, cleaning, filling, and troubleshooting, to ensure consistent and accurate filling of capsules.

3) Scope

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

4) Responsibilities

• Operators are responsible for setting up, operating, and cleaning capsule filling machines according to this SOP.
• Supervisors are responsible for overseeing the filling 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 filling area is clean and free of contaminants.
   2. Verify the availability and quality of raw materials and empty capsules as per the batch record.
   3. Check the cleanliness and readiness of the capsule filling machine.
2. Equipment Setup
   1. Assemble the capsule filling 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., capsule size, fill weight) according to the batch record.
3. Filling Process
   1. Load the empty capsules and raw materials into the designated hoppers.
   2. Start the machine and monitor the filling process continuously.
   3. Ensure that the fill weight meets the specified requirements by sampling filled capsules at regular intervals.
   4. Adjust the machine settings if necessary to maintain consistency.
   5. Document any observations and adjustments made during the filling process.
4. Troubleshooting
   1. If the machine malfunctions, stop the operation immediately and troubleshoot the issue.
   2. Refer to the manufacturer’s manual for troubleshooting guidelines.
   3. Document the issue and the corrective actions taken in the maintenance logbook.
   4. Resume operation once the issue is resolved and the machine is functioning properly.
5. Cleaning and Maintenance
   1. Turn off and disassemble the capsule filling 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