SOP for Calibration of Nebulizer Aerosol Generators

Standard Operating Procedure for Calibrating Nebulizer Aerosol Generators

1) Purpose

The purpose of this SOP is to outline the calibration procedure for nebulizer aerosol generators to ensure accurate and consistent aerosol output during production and testing.

2) Scope

This SOP applies to all aerosol generators used in nebulizer manufacturing, testing, and quality control processes within the facility.

3) Responsibilities

Operators: Assist with the calibration setup and record results.
Maintenance Team: Perform calibration and ensure proper functionality of aerosol generators.
Quality Assurance (QA): Validate calibration results and approve the calibration report.

4) Procedure

4.1 Pre-Calibration Checks

Inspect the aerosol generator for physical damage, wear, or blockages.
Ensure the calibration equipment (e.g., particle size analyzers) is within its calibration validity period.
Assemble the required calibration tools, including flow meters and reference solutions.
Document the equipment details, such as model number and serial number, in the Calibration Log.

4.2 Setting Up for Calibration

Connect the aerosol generator to a certified particle size analyzer or flow measurement device.
Fill the generator with the standard aerosol solution as specified in the product guidelines.
Configure the equipment parameters, such as flow rate and aerosol size, as per the calibration protocol.
Ensure the test environment is free from airflow disturbances or contaminants.

4.3

Calibration Process

Activate the aerosol generator and allow it to stabilize for the specified duration.
Measure the aerosol output using the connected calibration device and record the results.
Repeat the measurement at different flow rates or particle size settings to cover the generator’s operational range.
Compare the recorded values against the expected specifications provided by the manufacturer or regulatory standards.
If deviations exceed the acceptable range, adjust the generator settings and recalibrate.

4.4 Post-Calibration Verification

Perform a final round of measurements after adjustments to verify the accuracy of the aerosol generator.
Label the generator with the calibration status, date, and next due date.
Submit the calibration results and supporting documents to QA for validation.

4.5 Frequency of Calibration

Routine Calibration: Quarterly or as per the manufacturer’s recommendations.
Post-Maintenance Calibration: After repairs or replacement of critical components.
Annual Calibration: Comprehensive calibration by an external certified agency.

4.6 Handling Calibration Failures

Isolate the aerosol generator if it fails calibration and report the issue to the maintenance team.
Document the failure details in the Calibration Failure Report.
Implement corrective actions and repeat the calibration process before resuming use.

4.7 Safety Precautions

Wear personal protective equipment (PPE), including gloves and safety glasses, during calibration.
Handle aerosol solutions and calibration equipment as per their Material Safety Data Sheets (MSDS).
Ensure all electrical connections are secure to avoid accidents during calibration.

5) Abbreviations

QA: Quality Assurance
PPE: Personal Protective Equipment
MSDS: Material Safety Data Sheet

6) Documents

The following documents should be maintained:

Calibration Log
Calibration Report
Calibration Failure 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: Calibration Log

   Date  Generator ID  Reference Device ID  Deviation (%)  Performed By  Remarks  
  DD/MM/YYYY  Generator Identifier  Reference Device Identifier  Deviation Percentage  Technician Name  Details of calibration

Date	Generator ID	Reference Device ID	Deviation (%)	Performed By	Remarks
DD/MM/YYYY	Generator Identifier	Reference Device Identifier	Deviation Percentage	Technician Name	Details of calibration

Annexure Title: Calibration Report

   Date  Generator ID  Pre-Calibration Reading  Post-Calibration Reading  Performed By  QA Approval  
  DD/MM/YYYY  Generator Identifier  Pre-Reading  Post-Reading  Technician Name  QA Name

Date	Generator ID	Pre-Calibration Reading	Post-Calibration Reading	Performed By	QA Approval
DD/MM/YYYY	Generator Identifier	Pre-Reading	Post-Reading	Technician Name	QA Name

Annexure Title: Calibration Failure Report

   Date  Generator ID  Issue Identified  Corrective Action  Performed By  QA Approval  
  DD/MM/YYYY  Generator Identifier  Description of issue  Details of action  Technician Name  QA Name

Date	Generator ID	Issue Identified	Corrective Action	Performed By	QA Approval
DD/MM/YYYY	Generator Identifier	Description of issue	Details of action	Technician Name	QA Name