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 |
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 |
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 |