Standard Operating Procedure for Operation of Case Packer

1. Purpose

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

2. Scope

This SOP applies to all personnel involved in the operation of case packer 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 case packer 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 case blanks, product units, and utilities (e.g., electricity, compressed air) are available and functioning properly.

4.2. Set-Up

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

4.3. Case Packing Process

1. Start the case packer 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 packing into cases or cartons.
3. Monitor the case packing process closely to verify that products are accurately and consistently placed into cases or cartons.
4. Check for any incomplete cases, misplacements, or other defects and take corrective action as necessary.
5. Record the packing time, machine settings, and any deviations from the standard procedure.

4.4. Post-Packing Checks

1. Stop the case packer machine when the packing process is completed or as directed by the supervisor.
2. Perform visual inspections of the packed cases or cartons to verify proper product unit placement, sealing, and labeling if applicable.
3. Segregate and label any cases or cartons with defective packing for further evaluation or re-packing.

4.5. Cleaning and Maintenance

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

7. SOP Version

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