SOP for Calibration of Particle Size Analyzers for Nebulizers

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

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

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