Standard Operating Procedure for Cap Sealing Machines

1) Purpose

The purpose of this SOP is to provide guidelines for the operation and maintenance of cap sealing machines used in the manufacturing of dental dosage forms to ensure proper sealing of containers and compliance with regulatory standards.

2) Scope

This SOP applies to all cap sealing machines used in the manufacturing process of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Production Department is responsible for operating and cleaning the cap sealing machines. The Quality Assurance (QA) Department is responsible for verifying and documenting compliance with this SOP.

4) Procedure

4.1 Preparation

4.1.1 Verify that the cap sealing machine is clean and in good working condition before use.

4.1.2 Ensure all containers with caps are prepared and ready for sealing according to the batch record.

4.2 Setup and Adjustment

4.2.1 Set up the cap sealing machine as per the manufacturer’s instructions and batch record requirements.

4.2.2 Adjust machine settings such as temperature and pressure according to the cap and container specifications.

4.3 Sealing Process

4.3.1 Place containers with caps under the cap sealing unit of the machine.

4.3.2 Activate the cap sealing process according to the batch record and machine settings.

4.3.3 Monitor the sealing process to ensure proper sealing of caps onto containers.

4.3.4 Record start time, end time, and any deviations observed during sealing in the batch record.

4.4 Cleaning

4.4.1 After use, turn off the cap sealing machine and disconnect it from the power source.

4.4.2 Disassemble parts of the cap sealing machine and clean all contact surfaces using approved cleaning agents.

4.4.3 Rinse thoroughly with purified water to remove any residual cleaning agents.

4.4.4 Inspect the cap sealing machine for cleanliness and reassemble it after it is completely dry.

4.5 Maintenance

4.5.1 Perform regular preventive maintenance on the cap sealing machine as per the manufacturer’s guidelines.

4.5.2 Record all maintenance activities in the equipment maintenance log.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

Batch Record

Equipment Maintenance Log

7) Reference, if any

Current Good Manufacturing Practices (cGMP) guidelines

8) SOP Version

Version 1.0