Standard Operating Procedure for Operating Automated Nebulizer Inspection Systems
1) Purpose
The purpose of this SOP is to outline the procedure for the effective use of automated inspection systems to ensure the quality and integrity of nebulizer products during manufacturing.
2) Scope
This SOP applies to all automated nebulizer inspection systems used in the quality control process within the manufacturing facility.
3) Responsibilities
Operators: Operate the automated inspection system as per the instructions.
Quality Assurance (QA): Validate the inspection process and approve the inspected units.
Maintenance Team: Ensure the proper functioning and calibration of the inspection system.
4) Procedure
4.1 Pre-Operation Checks
- Inspect the automated inspection system for cleanliness and ensure no debris or residue is present.
- Verify the calibration status of sensors, cameras, and other inspection components.
- Ensure the system software is updated and the inspection criteria are programmed correctly.
- Document the system’s ID, date, and operator details in the Automated Inspection Log.
4.2 Setting Up the Inspection Process
- Load the nebulizer units onto the conveyor or input tray, ensuring proper alignment.
- Configure the inspection system for the specific product batch, including parameters such as dimensions, surface defects, and functionality.
- Run a test cycle to confirm the system is detecting defects accurately.
4.3
- Start the inspection process and monitor the system for any operational issues.
- Ensure the units pass through the inspection zones, such as visual, dimensional, and functional checks.
- Review the system’s output, including defect identification, pass/fail results, and photographic records.
- Segregate non-conforming units automatically or manually for further analysis.
4.4 Post-Inspection Activities
- Stop the inspection system and ensure all inspected units are accounted for.
- Review the inspection log generated by the system and cross-check with manual entries.
- Store the inspected conforming units in designated areas and label them with batch details.
- Clean the inspection system as per the cleaning SOP to prepare it for the next batch.
4.5 Handling Non-Conforming Units
- Label non-conforming units with “Rejected” tags and move them to the quarantine area.
- Document details of defects and actions taken in the Non-Conformance Report.
- Inform the QA team for further investigation and approval of corrective actions.
4.6 Safety Precautions
- Always wear personal protective equipment (PPE) while operating the system.
- Ensure all safety guards and emergency stops are functional before starting the process.
- Avoid placing hands or objects near moving parts during operation.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Automated Inspection Log
- Defect Analysis Report
- Non-Conformance 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: Automated Inspection Log
| Date | System ID | Batch No. | Defects Detected | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | System Identifier | Batch Identifier | Type and Number | Operator Name | Details of inspection |
Annexure Title: Defect Analysis Report
| Date | Batch No. | Defect Type | Quantity | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Defect Description | Number of Units | Operator Name | Details of analysis |
Annexure Title: Non-Conformance Report
| Date | Batch No. | Defect Type | Corrective Action | QA Approval | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Defect Description | Details of Actions | QA Name | Details of resolution |