Standard Operating Procedure for Operating Nebulizer Bottle Filling Machines
1) Purpose
The purpose of this SOP is to establish a standardized procedure for operating nebulizer bottle filling machines to ensure accurate, efficient, and contamination-free filling of nebulizer solutions.
2) Scope
This SOP applies to all bottle filling machines used in the manufacturing and packaging of nebulizer solutions within the facility.
3) Responsibilities
Operators: Operate the filling machine and monitor its performance during production.
Maintenance Team: Perform routine maintenance and troubleshoot any machine issues.
Quality Assurance (QA): Validate the filling process and approve batch records.
Production Supervisors: Ensure adherence to the SOP and coordinate machine operations.
4) Procedure
4.1 Pre-Operation Checks
- Inspect the filling machine for cleanliness and ensure it is free of residues from previous batches.
- Verify that the machine components, including nozzles and hoses, are intact and properly assembled.
- Calibrate the filling machine according to the batch size and volume requirements.
- Check the supply of bottles, caps, and nebulizer solution to ensure adequate inventory for the production run.
- Document pre-operation inspection details in the Bottle Filling Machine Log.
4.2 Setting Up the Machine
- Load the empty bottles onto the conveyor or feed them into the machine manually as required.
- Set the
4.3 Operating the Machine
- Start the filling process and monitor the machine for consistent operation.
- Inspect filled bottles periodically for accuracy in volume and absence of spills or overfills.
- Ensure proper synchronization of bottle movement with the filling nozzles to avoid misalignment.
- Record operational details, including batch number and operator initials, in the Operation Log.
4.4 Post-Operation Activities
- Stop the machine and remove any remaining bottles and caps from the system.
- Clean the filling machine thoroughly as per the cleaning SOP to prevent cross-contamination.
- Inspect the machine for wear or damage and report any issues to the maintenance team.
- Record the completion of the operation in the Bottle Filling Machine Log.
4.5 Handling Non-Conforming Products
- Segregate bottles with incorrect fill volumes or visible defects and label them as “Rejected.”
- Document the details of non-conformance in the Defective Product Report.
- Investigate the root cause and implement corrective actions before resuming production.
4.6 Safety Precautions
- Ensure the machine is turned off and isolated from the power supply before performing any maintenance or cleaning activities.
- Wear personal protective equipment (PPE), including gloves and safety glasses, during operation.
- Follow the manufacturer’s safety guidelines for handling and operating the filling machine.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Bottle Filling Machine Log
- Operation 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: Bottle Filling Machine Log
| Date | Machine ID | Batch No. | Parameters Set | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Machine Identifier | Batch Identifier | Details of parameters | Operator Name | Details of operation |
Annexure Title: Defective Product Report
| Date | Batch No. | Defect Type | Quantity | Reported By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Details of defect | Number of defective units | Technician Name | Details of resolution |
Annexure Title: Operation Log
| Date | Batch No. | Start Time | End Time | Performed By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | HH:MM | HH:MM | Operator Name | Details of operation |