Standard Operating Procedure for Operating Nebulizer Filling Pumps
1) Purpose
The purpose of this SOP is to outline the standardized procedure for operating nebulizer filling pumps to ensure accurate and consistent filling of nebulizer products while maintaining product quality.
2) Scope
This SOP applies to all filling pumps used in the nebulizer production lines within the manufacturing facility.
3) Responsibilities
Operators: Operate the filling pumps as per this SOP and ensure proper documentation.
Maintenance Team: Perform routine maintenance and troubleshooting of filling pumps.
Quality Assurance (QA): Validate the filling accuracy and ensure compliance with the batch specifications.
4) Procedure
4.1 Pre-Operation Checks
- Ensure the filling pump is cleaned as per the cleaning SOP and is free from any residue or contaminants.
- Inspect the pump for proper functioning, including seals, nozzles, and tubing connections.
- Verify the calibration status of the pump to ensure accuracy in volume delivery.
- Ensure that the nebulizer solution and containers are prepared and approved for filling.
- Document the pump’s identification details and pre-operation checks in the Filling Pump Operation Log.
4.2 Setting Up the Filling Pump
- Connect the filling pump to the solution container and ensure all tubing connections are secure.
- Set the filling volume, speed, and cycle parameters as per
4.3 Operating the Filling Pump
- Start the filling process and monitor the operation for consistent performance.
- Ensure that containers are aligned properly on the conveyor or filling station.
- Inspect the filled containers periodically for volume accuracy and sealing integrity.
- Record any deviations or anomalies during the filling process in the Equipment Observation Log.
4.4 Post-Operation Activities
- Stop the filling pump and disconnect it from the solution container.
- Clean the pump and associated equipment as per the cleaning SOP to prepare for the next batch.
- Inspect the pump for wear and tear, and report any issues to the maintenance team.
- Document the filling operation details and observations in the Filling Pump Operation Log.
4.5 Safety Precautions
- Always wear personal protective equipment (PPE), such as gloves and safety glasses, while operating the pump.
- Avoid placing hands or objects near moving parts during operation.
- Ensure that all electrical connections are secure and that the equipment is properly grounded.
4.6 Handling Non-Conforming Products
- Segregate containers that are overfilled, underfilled, or improperly sealed and label them as “Rejected.”
- Document the non-conformance details in the Defective Product Report.
- Inform the QA team for further investigation and corrective action.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Filling Pump Operation Log
- Equipment Observation Log
- Defective Product Report
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Good Manufacturing Practices (GMP) Guidelines
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Filling Pump Operation Log
| Date | Pump ID | Batch No. | Volume Set | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Pump Identifier | Batch Identifier | Set Volume (mL) | Operator Name | Details of operation |
Annexure Title: Equipment Observation Log
| Date | Pump ID | Observation | Action Taken | Performed By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Pump Identifier | Details of Observation | Corrective Actions | Operator Name | Details |
Annexure Title: Defective Product Report
| Date | Batch No. | Defect Type | Quantity | Reported By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Overfill/Underfill/Seal Defect | Number of Units | Operator Name | Details of defect |