Standard Operating Procedure for Tube Filling Machines

1) Purpose

The purpose of this SOP is to provide guidelines for the operation and maintenance of tube filling machines used in the manufacturing of dental dosage forms to ensure accurate and consistent filling of tubes and compliance with regulatory standards.

2) Scope

This SOP applies to all tube filling 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 tube filling 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 tube filling machine is clean and in good working condition before use.

4.1.2 Ensure all tubes and caps are prepared and ready for filling according to the batch record.

4.2 Setup and Calibration

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

4.2.2 Calibrate the tube filling machine to ensure accurate filling of tubes (volume or weight).

4.2.3 Verify calibration with standard weights or volumes as per the batch record.

4.3 Filling Operation

4.3.1 Start the tube filling machine and adjust the settings as per the batch record (e.g., fill volume, speed).

4.3.2 Load tubes