Standard Operating Procedure for Inspecting and Testing Nebulizer Components
1) Purpose
The purpose of this SOP is to define a systematic approach for the inspection and testing of nebulizer components to ensure they meet quality standards and regulatory compliance.
2) Scope
This SOP applies to all components used in the manufacturing of nebulizers, including housings, nozzles, filters, and tubing, during incoming inspection, in-process checks, and final testing.
3) Responsibilities
Quality Control (QC) Inspectors: Perform inspections and testing as per the defined procedure.
Operators: Provide components and facilitate testing.
Quality Assurance (QA): Verify and approve inspection reports.
4) Procedure
4.1 Incoming Inspection
- Check the packaging of incoming components for damage or tampering.
- Verify the components against the supplier’s Certificate of Analysis (COA) for material specifications.
- Conduct visual inspections to identify surface defects, such as cracks, discoloration, or deformities.
- Record the results in the Incoming Inspection Log.
4.2 In-Process Inspection
- Perform dimensional checks using calibrated measuring tools, such as calipers or micrometers, to ensure the components meet design specifications.
- Verify the fit and assembly of components during the assembly process to prevent alignment issues.
- Conduct random sampling at regular intervals as per the sampling plan.
- Document findings in the In-Process Inspection Log.
4.3 Final Testing
- Inspect the fully assembled nebulizers for proper integration of components.
- Test critical functionalities, such as air flow, aerosol generation, and leak resistance.
- Perform stress tests to verify durability under operating conditions.
- Record the results in the Final Testing Log and segregate non-conforming units for further analysis.
4.4 Handling Non-Conforming Components
- Isolate defective components and label them as “Non-Conforming.”
- Inform the Quality Assurance team for disposition decisions.
- Record all non-conformities in the Non-Conformance Report.
4.5 Frequency of Inspections
- Incoming: Each shipment received.
- In-Process: Random sampling per batch.
- Final Testing: Every batch before release.
5) Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- COA: Certificate of Analysis
6) Documents
The following documents should be maintained:
- Incoming Inspection Log
- In-Process Inspection Log
- Final Testing Log
- Non-Conformance Report
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: Incoming Inspection Log
| Date | Component Name | Supplier | Inspection Status | Inspector Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Component Identifier | Supplier Name | Pass/Fail | Inspector Name | Details of inspection findings |
Annexure Title: Final Testing Log
| Date | Batch No. | Test Performed | Result | Inspector Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Test Type | Pass/Fail | Inspector Name | Details of test results |
Annexure Title: Non-Conformance Report
| Date | Component Name | Defect Type | Inspector Initials | Disposition | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Component Identifier | Defect Description | Inspector Name | Rework/Scrap | Details of defect and resolution |