Standard Operating Procedure for Using Tube Filling Machine

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the tube filling machine used in the manufacturing of otic dosage forms to ensure accurate and consistent filling of tubes.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the tube filling machine in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the tube filling machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the filling process and verifying the accuracy of the fill volumes.
Maintenance Personnel: Responsible for maintaining the tube filling machine in proper working condition.

4) Procedure

4.1 Operation
4.1.1 Preparation
4.1.1.1 Ensure the tube filling machine is on a stable, level surface.
4.1.1.2 Check that the machine is clean and free of any debris.
4.1.1.3 Verify that the machine is properly calibrated and functioning.

4.1.2 Loading the Machine
4.1.2.1 Prepare the tubes and the product to be filled as per the batch record.
4.1.2.2 Load the empty tubes into the machine’s feeding system.
4.1.2.3 Fill the product hopper with the product to be dispensed.

4.1.3 Filling Process
4.1.3.1 Select the appropriate filling parameters (e.g., volume, speed) as per the batch record.
4.1.3.2 Start the machine and monitor the filling process.
4.1.3.3 Ensure that each tube is filled accurately and consistently.
4.1.3.4 After the filling cycle is complete, stop the machine.

4.1.4 Unloading the Machine
4.1.4.1 Carefully remove the filled tubes from the machine.
4.1.4.2 Inspect the tubes to ensure they are properly filled and free from defects.

4.2 Calibration
4.2.1 Daily Check
4.2.1.1 Perform a daily check of the machine’s settings and indicators.
4.2.1.2 Record the results in the equipment log.

4.2.2 Monthly Calibration
4.2.2.1 Conduct a full calibration of the tube filling machine monthly using standard test methods.
4.2.2.2 Document the calibration results and any adjustments made.

4.3 Maintenance
4.3.1 Routine Maintenance
4.3.1.1 Clean the machine and all parts regularly to prevent contamination.
4.3.1.2 Inspect the machine for any signs of wear or damage and replace parts as necessary.

4.3.2 Troubleshooting
4.3.2.1 If the machine displays error messages or fails to reach the required conditions, refer to the manufacturer’s manual for troubleshooting steps.
4.3.2.2 Contact maintenance personnel if the issue cannot be resolved.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Filling log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the tube filling machine
Regulatory guidelines for equipment calibration and maintenance

8) SOP Version

Version 1.0