SOP for Inspection of Nebulizer Container Integrity

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

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

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

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