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