SOP for Inspection and Testing of Nebulizer Components

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

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

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

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