Standard Operating Procedure for Inspecting Nebulizer Container Integrity
1) Purpose
The purpose of this SOP is to establish a standardized procedure for inspecting the integrity of nebulizer containers to ensure they meet quality standards and protect the product from contamination or leakage.
2) Scope
This SOP applies to all nebulizer containers used in the manufacturing, storage, and distribution processes within the facility.
3) Responsibilities
Operators: Conduct routine inspections and document findings.
Quality Control (QC) Team: Perform detailed integrity tests and verify compliance with specifications.
Quality Assurance (QA): Approve inspection records and take necessary actions for non-conformities.
Maintenance Team: Address any equipment issues related to inspection processes.
4) Procedure
4.1 Pre-Inspection Activities
- Ensure the inspection area and equipment are clean and free from any contamination.
- Verify that all necessary tools and equipment, such as vacuum testers, pressure testers, and visual inspection stations, are calibrated and functional.
- Retrieve the batch record and verify that the containers to be inspected match the specifications outlined in the batch documents.
4.2 Visual Inspection
- Inspect each container for visible defects such as cracks, dents, discoloration, or incomplete sealing.
- Check the cap and seal for proper alignment and intactness.
- Mark defective containers with a “Rejected” label and segregate them for further evaluation.
4.3 Physical Integrity Testing
- Conduct vacuum or pressure tests on containers to verify their resistance to leaks:
- Vacuum Test: Place the container in a vacuum chamber and reduce the pressure. Observe for any signs of air bubbles or structural deformation.
- Pressure Test: Apply pressure inside the container using a pressure tester and monitor for leaks or bursts.
- Perform dye penetration tests by submerging containers in a dye solution and observing for leaks.
- Record all test results in the Container Integrity Test Log.
4.4 Batch Sampling and Statistical Analysis
- Inspect a representative sample from each batch as per the sampling plan outlined in the batch record.
- Perform statistical analysis of the sample results to determine batch acceptability.
- If the batch fails to meet the acceptable quality limit (AQL), escalate to QA for investigation.
4.5 Post-Inspection Activities
- Segregate and document containers that pass inspection for further processing or shipment.
- Dispose of or rework rejected containers as per the facility’s guidelines.
- Submit inspection records to QA for review and approval.
4.6 Handling Non-Conforming Products
- Document all non-conforming containers in the Defective Product Report.
- Investigate the root cause and take corrective actions to prevent recurrence.
- Do not release the batch until QA approves the resolution of non-conformities.
4.7 Safety Precautions
- Wear personal protective equipment (PPE), such as gloves and safety glasses, during inspection activities.
- Handle testing equipment with care to avoid damage or injury.
- Follow the manufacturer’s instructions for operating vacuum and pressure testers.
5) Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- PPE: Personal Protective Equipment
- AQL: Acceptable Quality Limit
6) Documents
The following documents should be maintained:
- Container Integrity Test Log
- Batch Sampling Record
- 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: Container Integrity Test Log
| Date | Batch No. | Test Type | Result | Performed By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Vacuum/Pressure/Dye | Pass/Fail | Technician Name | Details of test |
Annexure Title: Batch Sampling Record
| Date | Batch No. | Sample Size | Defects Found | Performed By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Number of units | Details of defects | Inspector Name | Comments |
Annexure Title: Defective Product Report
| Date | Batch No. | Defect Type | Quantity | Reported By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Identifier | Crack/Leak/Dent | Number of units | Technician Name | Details of resolution |