Standard Operating Procedure for Operating Nebulizer Cap Sealing Machines
1) Purpose
The purpose of this SOP is to establish a standardized procedure for the operation of cap sealing machines used in nebulizer production to ensure secure and consistent sealing of caps, maintaining product integrity.
2) Scope
This SOP applies to all cap sealing machines utilized during the production and packaging of nebulizer units within the manufacturing facility.
3) Responsibilities
Operators: Operate the cap sealing machine as per this SOP and monitor its performance.
Maintenance Team: Conduct routine maintenance and troubleshooting of the cap sealing machine.
Quality Assurance (QA): Inspect and validate sealing operations and approve batch records.
4) Procedure
4.1 Pre-Operation Checks
- Inspect the cap sealing machine for cleanliness and ensure no leftover material from the previous operation.
- Verify the machine’s settings, such as torque and pressure, according to the product specifications.
- Ensure the caps and bottles are compatible and free from damage or contamination.
- Record pre-operation inspection details in the Cap Sealing Machine Log.
4.2 Setting Up the Machine
- Load caps into the feeder and bottles onto the conveyor system, ensuring proper alignment.
- Adjust the machine parameters, such as speed and sealing pressure, as per the batch requirements.
- Run a trial with a small batch to confirm alignment, torque, and sealing consistency.
4.3 Operating the Cap Sealing Machine
- Start the machine and monitor the sealing process for smooth operation.
- Regularly inspect sealed units for defects, such as loose caps or damaged seals, during the run.
- Document operational details, including batch number and operator initials, in the Operation Log.
4.4 Post-Operation Activities
- Stop the machine and unload any remaining caps and bottles from the system.
- Clean the machine as per the cleaning SOP to prepare it for the next use.
- Inspect the machine components for wear or damage and report any issues to the maintenance team.
- Record post-operation activities in the Cap Sealing Machine Log.
4.5 Handling Non-Conforming Products
- Segregate products with defective seals and label them as “Rejected.”
- Document the non-conformance in the Defective Product Report and inform the QA team for further investigation.
- Do not release the batch until all defective units are resolved or replaced.
4.6 Safety Precautions
- Wear personal protective equipment (PPE), such as gloves and safety glasses, during operation.
- Ensure emergency stop buttons and safety guards are functional before starting the machine.
- Avoid placing hands or objects near moving parts while the machine is in operation.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Cap Sealing Machine Log
- Defective Product Report
- Maintenance Record
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: Cap Sealing Machine Log
| Date | Machine ID | Batch No. | Settings Applied | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Machine Identifier | Batch Identifier | Details of settings | Operator Name | Details of operation |
Annexure Title: Defective Product Report
| Date | Batch No. | Defect Type | Quantity | Reported By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Loose cap/Damaged seal | Number of units | Operator Name | Details of defect |
Annexure Title: Maintenance Record
| Date | Machine ID | Maintenance Type | Performed By | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Machine Identifier | Routine/Corrective | Technician Name | QA Name | Details of maintenance |