Standard Operating Procedure for Ointment Preparation Tank

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Ointment Preparation Tank used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Ointment Preparation Tank 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 Ointment Preparation Tank. The equipment 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 ointment preparation tank and surrounding area are clean and sanitized.
2. Verify that all necessary materials (base ointments, active pharmaceutical ingredients) and equipment are available and within expiry dates.
3. Check that the ointment preparation tank is properly connected to utilities (steam, air, etc.) if required.

4.2 Operation

1. Turn on the ointment preparation tank and verify that the temperature and mixing settings are appropriate for the ointment formulation.
2. Add the required raw materials into the tank according to the batch formulation.
3. Start the mixing process as per the specified parameters.
4. Monitor the temperature and mixing process to ensure the ointment formulation is homogenous.
5. Once the ointment preparation is complete, stop the mixing process.

4.3 Post-Operation

1. Transfer the prepared ointment to the designated storage container or directly to the filling machine, if applicable.
2. Clean the ointment preparation tank and all associated equipment thoroughly as per the cleaning procedure.
3. Record the details of the ointment preparation (batch number, quantity produced, any deviations) in the batch record logbook.

4.4 Maintenance

1. Regularly inspect the ointment preparation tank for cleanliness and signs of wear.
2. Perform preventive maintenance tasks such as checking seals, lubricating moving parts, and inspecting heating elements.
3. Calibrate temperature controls periodically to maintain process accuracy.
4. Replace any worn-out parts or components as per the maintenance schedule.

5) Abbreviations, if any

None

6) Documents, if any

1. Batch record 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