Standard Operating Procedure for Operation of ROPP Cap Sealing Machine

1. Purpose

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

2. Scope

This SOP applies to all personnel involved in the operation of ROPP cap sealing 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

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

4.2. Set-Up

Position the ROPP cap sealing machine in the designated location for operation.
Adjust the machine settings, including cap head and sealing pressure, according to the product specifications and batch record.
Load empty containers with ROPP caps onto the conveyor or infeed system, ensuring they are properly oriented for sealing.

4.3. Cap Sealing Process

Start the ROPP cap sealing

machine according to the manufacturer’s instructions and the parameters specified in the batch record or formula.

Ensure that the machine is set to the correct sealing pressure and that the caps are properly aligned with the containers.

Monitor the sealing process closely to verify that caps are securely sealed to the containers.

Check for any misfeeds, jams, or improperly sealed containers and take corrective action as necessary.

Record the sealing time, sealing pressure, and any deviations from the standard procedure.

4.4. Post-Sealing Checks

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

4.5. Cleaning and Maintenance

Clean the ROPP cap sealing machine and associated equipment after use, following the cleaning procedure.
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 ROPP cap sealing machine operation, including pre-operation checks, machine settings, sealing parameters, and post-sealing 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 ROPP cap sealing machines in the pharmaceutical industry.]

7. SOP Version

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