Standard Operating Procedure for Operation of Capping Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a capping machine in pharmaceutical manufacturing. This ensures the correct sealing and capping of containers while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of capping machines within the pharmaceutical manufacturing facility.

3. Responsibilities

• Machine Operator: Responsible for following the procedures outlined in this SOP during machine operations.
• Supervisor: Oversees and verifies compliance with this SOP, including training and documentation.

4. Procedure

4.1. Pre-Operation Checks

1. Inspect the capping machine for any visible damage, jams, or defects. Report any issues to the supervisor.
2. Ensure that the machine is clean and free from any residues or contaminants from previous operations.
3. Verify that all necessary utilities (e.g., electricity, air pressure) are available and functioning properly.

4.2. Set-Up

1. Position the capping machine in the designated location for operation.
2. Adjust the machine settings, including capping head or chuck, to match the type and size of containers to be capped.
3. Load empty containers onto the conveyor or infeed system, ensuring they are properly oriented for capping.

4.3. Capping Process

1. Start the capping machine according to the manufacturer’s instructions and the parameters specified in the batch record or formula.
2. Monitor the capping process closely to verify that caps or closures are applied correctly and securely to the containers.
3. Check for any misfeeds, jams, or improperly capped containers and take corrective action as necessary.
4. Record the capping time, speed, and any deviations from the standard procedure.

4.4. Post-Capping Checks

1. Stop the capping machine when the capping process is completed or as directed by the supervisor.
2. Perform visual inspections of the capped containers to ensure proper sealing and alignment of caps.
3. Verify that container labels, lot numbers, and expiration dates are accurate and legible.

4.5. Cleaning and Maintenance

1. Clean the capping machine and associated equipment after use, following the cleaning procedure.
2. Perform routine maintenance as per the manufacturer’s recommendations to ensure the machine’s continued performance.

4.6. Documentation

Properly document all aspects of the capping machine operation, including pre-operation checks, machine settings, capping parameters, and post-capping checks. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices

6. Reference

[Insert any relevant references or standards applicable to the operation of capping machines in the pharmaceutical industry.]

7. SOP Version

This is version 1.0 of the “Operation of Capping Machine SOP,” issued on [insert issuance date].