Standard Operating Procedure for Ampoule Filling Machine Operation
1) Purpose
The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Ampoule Filling Machine used in the manufacturing of ocular dosage forms.
2) Scope
This SOP applies to the Ampoule Filling Machine 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 Ampoule Filling Machine. 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
- Ensure the ampoule filling machine and surrounding area are clean and sanitized.
- Verify that all necessary materials and equipment are available and within expiry dates.
- Check that the ampoule filling machine is connected to the appropriate power supply and is functioning properly.
4.2 Operation
- Turn on the ampoule filling machine and allow it to perform its self-checks.
- Load the ampoules and the sterile solution into the machine’s feed system.
- Set the desired parameters (filling volume, speed) on the machine control panel.
- Initiate the filling process by pressing the start button on the machine.
- Monitor the filling process to ensure accuracy and sterility are maintained.
- Once filling is complete, inspect the filled ampoules
for any defects.
Transfer the filled ampoules to the designated storage area for further processing.
4.3 Post-Operation
- Turn off the ampoule filling machine and disconnect it from the power supply.
- Clean all contact parts and the surrounding area as per the cleaning procedure.
- Record the operation details in the equipment logbook.
4.4 Maintenance
- Regularly inspect the ampoule filling machine for wear and tear.
- Lubricate moving parts as per the manufacturer’s recommendations.
- Perform calibration checks as per the schedule to ensure consistent filling accuracy.
- Replace any worn-out parts promptly to maintain the efficiency of the machine.
5) Abbreviations, if any
None
6) Documents, if any
- Equipment logbook
- Maintenance record
- Calibration record
7) Reference, if any
GMP Guidelines for pharmaceutical production and equipment handling.
8) SOP Version
Version 1.0
