Standard Operating Procedure for Sealing Gel Tubes

1) Purpose

The purpose of this SOP is to provide guidelines for the proper sealing of gel tubes to ensure the sterility and integrity of the ocular dosage forms during and after the sealing process.

2) Scope

This SOP applies to all gel tubes filled with ocular dosage forms within the pharmaceutical manufacturing facility, ensuring that they are securely sealed to prevent contamination and leakage.

3) Responsibilities

The responsibilities include operating the sealing equipment, monitoring the sealing process, and maintaining the sealing machinery. Production staff are responsible for following this procedure, and the maintenance team is responsible for regular checks and servicing of the sealing equipment.

4) Procedure

4.1 Preparation

1. Ensure that the sealing machine is clean and properly sanitized.
2. Verify that the gel tubes are filled and capped correctly.
3. Set up the sealing machine according to the manufacturer’s instructions, including adjusting the sealing parameters.

4.2 Sealing Process

1. Place the filled and capped gel tubes on the conveyor belt of the sealing machine.
2. Start the sealing machine and monitor the sealing process to ensure proper operation.
3. Check the sealed tubes for any defects or irregularities, such as improper seals or leaks.
4. Remove any defective tubes from the production line and investigate the cause of the defect.
5. Continue the sealing process until all tubes in the batch are sealed.

4.3 Post-Sealing Inspection

1. Inspect the sealed tubes for any visible defects or inconsistencies.
2. Perform a leak test on a sample of sealed tubes to ensure the integrity of the seals.
3. Document the results of the leak test and any defects found during the inspection.

4.4 Maintenance

1. Perform regular cleaning and maintenance of the sealing machine as per the manufacturer’s recommendations.
2. Check and replace any worn or damaged parts to ensure the machine’s reliability.
3. Document all maintenance activities in the maintenance logbook.

5) Abbreviations, if any

None

6) Documents, if any

1. Sealing machine logbook
2. Maintenance records
3. Leak test results

7) Reference, if any

GMP Guidelines for sealing processes in pharmaceutical manufacturing.

8) SOP Version

Version 1.0