Standard Operating Procedure for Ointment Tubing Sealer Operation

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Tubing Sealer for Ointments used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Tubing Sealer for Ointments used in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Tubing Sealer for Ointments. The machine operator is responsible for following the procedure, and the maintenance team is responsible for regular maintenance and calibration.

4) Procedure

4.1 Preparation

1. Ensure the tubing sealer and surrounding area are clean and sanitized.
2. Verify that all necessary materials and equipment are available and within expiry dates.
3. Check that the tubing sealer is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on the tubing sealer and allow it to warm up as per the manufacturer’s instructions.
2. Load the ointment tubes into the sealer’s feed system.
3. Adjust the sealing parameters (temperature, pressure, time) according to the specific ointment tube being sealed.
4. Initiate the sealing process by pressing the start button.
5. Monitor the sealing process to ensure that the seals are uniform and free from defects.
6. Once sealing is complete, inspect the sealed tubes for integrity and quality.
7. Collect the sealed tubes and transfer them to the designated storage area.

4.3 Post-Operation

1. Turn off the tubing sealer and disconnect it from the power supply.
2. Clean the sealer and surrounding area according to the cleaning procedure.
3. Record the operation details in the equipment logbook.

4.4 Maintenance

1. Regularly inspect the tubing sealer for any signs of wear or damage.
2. Lubricate moving parts as per the manufacturer’s recommendations.
3. Perform calibration checks as per the schedule to ensure consistent sealing quality.
4. Replace any worn-out parts promptly to maintain the efficiency of the sealer.

5) Abbreviations, if any

None

6) Documents, if any

1. Equipment logbook
2. Maintenance record
3. Calibration record

7) Reference, if any

GMP Guidelines for pharmaceutical production and equipment handling.

8) SOP Version

Version 1.0