Standard Operating Procedure for Operation of Cartoning Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a cartoning machine in pharmaceutical manufacturing. This ensures the correct packaging of product units into cartons while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of cartoning 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 cartoning machine for any visible damage, malfunctions, 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 carton blanks, product units, and utilities (e.g., electricity) are available and functioning properly.

4.2. Set-Up

1. Position the cartoning machine in the designated location for operation.
2. Load carton blanks into the machine’s magazine, ensuring they are properly aligned and securely held.
3. Adjust the machine settings, including carton size, product unit placement, and labeling, according to the product specifications and batch record.

4.3. Cartoning Process

1. Start the cartoning machine according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Feed product units into the machine’s hopper or infeed system, ensuring they are properly oriented for cartoning.
3. Monitor the cartoning process closely to verify that product units are accurately and consistently packaged into cartons.
4. Check for any carton defects, misfeeds, or improperly packaged units and take corrective action as necessary.
5. Record the cartoning time, machine settings, and any deviations from the standard procedure.

4.4. Post-Cartoning Checks

1. Stop the cartoning machine when the cartoning process is completed or as directed by the supervisor.
2. Perform visual inspections of the cartons to verify proper product unit placement, labeling, and carton integrity.
3. Segregate and label any defective cartons for further evaluation or disposal.

4.5. Cleaning and Maintenance

1. Clean the cartoning 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 cartoning machine operation, including pre-operation checks, machine settings, cartoning parameters, and post-cartoning 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 cartoning machines in the pharmaceutical industry.]

7. SOP Version

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