Standard Operating Procedure for Operation of Induction Sealer

1. Purpose

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

2. Scope

This SOP applies to all personnel involved in the operation of induction sealers 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 induction sealer 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 utilities (e.g., electricity, cooling water) are available and functioning properly.

4.2. Set-Up

1. Position the induction sealer in the designated location for operation.
2. Adjust the machine settings, including sealing power and sealing head height, according to the product specifications and batch record.
3. Load containers with induction-sealed caps onto the conveyor or infeed system, ensuring they are properly oriented for sealing.

4.3. Sealing Process

1. Start the induction sealer according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Ensure that the machine is set to the correct sealing power and that the caps are properly aligned with the sealing head.
3. Monitor the sealing process closely to verify that caps are securely sealed to the containers.
4. Check for any misfeeds, jams, or improperly sealed containers and take corrective action as necessary.
5. Record the sealing time, sealing power, and any deviations from the standard procedure.

4.4. Post-Sealing Checks

1. Stop the induction sealer when the sealing process is completed or as directed by the supervisor.
2. Perform visual inspections of the sealed containers to ensure proper seal integrity 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 induction sealer 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 induction sealer 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 induction sealers in the pharmaceutical industry.]

7. SOP Version

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