Standard Operating Procedure for Operation of Desiccant Inserter

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a desiccant inserter in pharmaceutical manufacturing. This ensures the correct insertion of desiccant packets into product containers while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of desiccant inserters 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 desiccant inserter 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, compressed air) are available and functioning properly.
4. Check that an adequate supply of desiccant packets is available and properly stored.

4.2. Set-Up

1. Position the desiccant inserter in the designated location for operation.
2. Load the desiccant packets into the machine’s feed system, ensuring they are properly aligned and securely attached to the inserter.
3. Adjust the machine settings, including insertion depth and speed, according to the product specifications and batch record.

4.3. Desiccant Insertion Process

1. Start the desiccant inserter according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Monitor the insertion process closely to verify that desiccant packets are accurately and consistently inserted into product containers.
3. Check for any misfeeds, jams, or improperly inserted desiccant packets and take corrective action as necessary.
4. Record the insertion time, insertion depth, and any deviations from the standard procedure.

4.4. Post-Insertion Checks

1. Stop the desiccant inserter when the insertion process is completed or as directed by the supervisor.
2. Perform visual inspections of the containers to ensure proper desiccant packet insertion and alignment.
3. Verify that desiccant packets are intact and of the correct type and quality.

4.5. Cleaning and Maintenance

1. Clean the desiccant inserter 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 desiccant inserter operation, including pre-operation checks, machine settings, insertion parameters, and post-insertion 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 desiccant inserters in the pharmaceutical industry.]

7. SOP Version

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