Standard Operating Procedure for Operation of Shrink Wrapping Machine

1. Purpose

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

2. Scope

This SOP applies to all personnel involved in the operation of shrink wrapping 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 shrink wrapping 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 shrink film rolls and utilities (e.g., electricity, compressed air) are available and functioning properly.

4.2. Set-Up

1. Position the shrink wrapping machine in the designated location for operation.
2. Load the shrink film roll onto the machine, ensuring proper alignment and tension control.
3. Adjust the machine settings, including film speed, sealing temperature, and cutting parameters, according to the product specifications and batch record.

4.3. Shrink Wrapping Process

1. Start the shrink wrapping machine according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Feed the products to be wrapped onto the conveyor or infeed system, ensuring they are properly oriented for wrapping.
3. Monitor the wrapping process closely to verify that products are accurately and consistently sealed and packaged in shrink film.
4. Check for any film tears, incomplete seals, or other defects and take corrective action as necessary.
5. Record the wrapping time, machine settings, and any deviations from the standard procedure.

4.4. Post-Wrapping Checks

1. Stop the shrink wrapping machine when the wrapping process is completed or as directed by the supervisor.
2. Perform visual inspections of the wrapped products to verify proper sealing, film integrity, and labeling if applicable.
3. Segregate and label any defective products for further evaluation or disposal.

4.5. Cleaning and Maintenance

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

7. SOP Version

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