Standard Operating Procedure for Calibrating Particle Size Analyzers Used in Nebulizer Testing
1) Purpose
The purpose of this SOP is to define a standardized procedure for the calibration of particle size analyzers to ensure accurate and reliable measurement of aerosol particle sizes in nebulizer products.
2) Scope
This SOP applies to all particle size analyzers used in the quality control and testing of nebulizers within the manufacturing facility.
3) Responsibilities
Operators: Perform basic calibration checks and operate the particle size analyzer.
Quality Assurance (QA): Review calibration records and approve analyzer functionality.
Maintenance Team: Conduct scheduled calibration, troubleshooting, and advanced maintenance.
4) Procedure
4.1 Pre-Calibration Preparation
- Ensure the particle size analyzer is clean and free of dust, debris, or residues.
- Verify that the required calibration standards, such as polystyrene microspheres or other certified reference materials, are available and within their validity period.
- Check the analyzer’s power supply and ensure all connections are secure.
- Document the analyzer’s identification details, including model number and serial number, in the calibration log.
4.2 Calibration Procedure
- Turn on the particle size analyzer and allow it to warm up as per the manufacturer’s guidelines.
- Run a system diagnostic test to ensure the analyzer’s components, such as lasers, detectors, and pumps, are functioning correctly.
- Prepare the calibration standard by diluting it according to the manufacturer’s instructions, if applicable.
- Load the calibration standard into the analyzer following the operational manual’s procedure.
- Set the analyzer to calibration mode and select the appropriate parameters, such as particle size range and refractive index.
- Initiate the calibration process and monitor the analyzer’s output to verify it matches the expected reference values.
- Repeat the calibration process three times to confirm consistency and reliability.
4.3 Post-Calibration Verification
- Run a sample test using a known standard to validate the accuracy of the calibrated analyzer.
- Document the calibration results and include the expected and observed values in the Particle Size Analyzer Calibration Log.
- Label the analyzer with the calibration date, next due date, and initials of the person performing the calibration.
4.4 Frequency of Calibration
- Routine Calibration: Monthly or as specified in the analyzer’s manual.
- Post-Maintenance Calibration: After any repairs or replacement of critical components.
- Annual Calibration: Comprehensive calibration by a certified third-party vendor.
4.5 Handling Calibration Errors
- If calibration fails, isolate the analyzer and notify the maintenance team for troubleshooting.
- Record any issues and corrective actions taken in the Calibration Error Report.
- Do not use the analyzer until it has been successfully recalibrated and validated.
5) Abbreviations
- QA: Quality Assurance
- PPE: Personal Protective Equipment
6) Documents
The following documents should be maintained:
- Particle Size Analyzer Calibration Log
- Calibration Error Report
- Calibration Validation Records
7) References
Relevant regulatory guidelines and references include:
- ISO 21501: Determination of Particle Size Distribution
- Good Laboratory Practices (GLP) Guidelines
- Equipment Manufacturer’s Manual
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Particle Size Analyzer Calibration Log
| Date | Analyzer ID | Standard Used | Expected Value | Observed Value | Operator Initials | Remarks |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Analyzer Identifier | Standard Name | Reference Value | Measured Value | Operator Name | Details of calibration |
Annexure Title: Calibration Error Report
| Date | Analyzer ID | Error Observed | Corrective Action | Performed By | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Analyzer Identifier | Error Description | Action Taken | Operator Name | QA Name |
Annexure Title: Calibration Validation Records
| Date | Analyzer ID | Validation Standard | Validation Status | Performed By | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Analyzer Identifier | Standard Name | Pass/Fail | Operator Name | Details of validation |