Standard Operating Procedure for Operating Nebulizer Sealing Machines
1) Purpose
The purpose of this SOP is to establish a standardized procedure for operating nebulizer sealing machines to ensure proper sealing of components and maintain product integrity.
2) Scope
This SOP applies to all nebulizer sealing machines used during the assembly and packaging process in the production facility.
3) Responsibilities
Operators: Operate sealing machines and monitor performance.
Maintenance Team: Perform routine maintenance and troubleshoot issues.
Quality Assurance (QA): Validate the sealing process and approve the output for compliance with quality standards.
4) Procedure
4.1 Pre-Operation Checks
- Ensure the sealing machine is clean and free of any residual material or debris from previous batches.
- Verify that all safety guards are in place and functional.
- Inspect the machine components, including heating elements and pressure plates, for any signs of damage or wear.
- Calibrate the machine settings, such as temperature, pressure, and sealing duration, as per the batch requirements.
- Perform a dry run without any components to confirm the machine is functioning correctly.
4.2 Machine Operation
- Load the components (e.g., nebulizer housings or caps) into the machine manually or via the conveyor system, ensuring proper alignment.
- Start the sealing process by activating the control panel or foot pedal,
4.3 In-Process Monitoring
- Perform random sampling at regular intervals during the sealing process to check for defects, such as incomplete seals or overheating.
- Adjust machine settings if any deviations are observed in sealing quality.
- Document any adjustments made in the Equipment Operation Log.
4.4 Post-Operation Activities
- Turn off the machine and allow it to cool before cleaning or maintenance.
- Inspect the sealed components to ensure they meet quality standards and segregate any defective units.
- Clean the machine as per the cleaning SOP to prevent contamination or residue buildup.
- Record the batch details and machine performance in the logbook.
4.5 Safety Precautions
- Always wear personal protective equipment (PPE), including gloves and safety glasses, during operation.
- Ensure proper grounding of the machine to avoid electrical hazards.
- Do not touch the heating elements or pressure plates while the machine is operational.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Equipment Operation Log
- Batch Sealing Report
- Sealing Defect Log
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Equipment Operation Log
| Date | Machine ID | Batch No. | Parameters Set | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Machine Identifier | Batch Number | Temperature, Pressure, Time | Operator Name | Details of operation |
Annexure Title: Batch Sealing Report
| Date | Batch No. | Sealed Units | Defective Units | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Number of Units | Number of Units | QA Name | Details of batch |
Annexure Title: Sealing Defect Log
| Date | Batch No. | Defect Type | Operator Initials | Action Taken | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Defect Description | Operator Name | Correction/Rework | Details of defect |