SOP for Calibration of Nebulizer Particle Counters

Standard Operating Procedure for Calibrating Nebulizer Particle Counters

1) Purpose

The purpose of this SOP is to define the standardized procedure for calibrating nebulizer particle counters to ensure accurate and reliable particle size measurement, which is critical for product quality and regulatory compliance.

2) Scope

This SOP applies to all particle counters used for monitoring and validating nebulizer solution and aerosol particle size in the facility.

3) Responsibilities

Operators: Assist with calibration setup and document activities.
Maintenance Team: Perform the calibration of particle counters and address any issues.
Quality Assurance (QA): Validate calibration results and approve calibration records.
Supervisors: Oversee calibration activities and ensure adherence to the SOP.

4) Procedure

4.1 Pre-Calibration Checks

Ensure the particle counter is clean, free from any contamination, and powered off.
Verify that the calibration equipment, such as standard particle generators, is within its calibration validity period.
Review the equipment manual to identify specific calibration requirements.
Document the particle counter details, such as model and serial number, in the Calibration Log.

4.2 Calibration Setup

Connect the particle counter to the calibration test bench as per the manufacturer’s instructions.
Prepare the particle size reference standards or calibration aerosols.
Ensure that the testing environment meets the specified conditions, such as

temperature and humidity.

4.3 Calibration Procedure

Power on the particle counter and allow it to stabilize for the recommended warm-up period.
Introduce the reference particles or calibration aerosols into the particle counter using a clean and sealed delivery system.
Measure the particle size and concentration using the counter and compare the results with the known reference standards.
Adjust the particle counter’s settings if deviations from the reference values are identified.
Repeat the calibration process for multiple particle sizes within the instrument’s operational range.
Record all readings and adjustments in the Calibration Report.

4.4 Post-Calibration Activities

Disconnect the particle counter from the test bench and clean any components exposed to calibration aerosols.
Label the particle counter with the calibration status, date, and next due date.
Submit the calibration report to QA for validation and approval.
Update the Calibration Log with the details of the activity.

4.5 Frequency of Calibration

Routine Calibration: Annually or as specified by the manufacturer.
Post-Maintenance Calibration: After repairs or replacement of critical components.

4.6 Handling Calibration Failures

Isolate the particle counter if calibration fails and report the issue to the maintenance team.
Document the failure details in the Calibration Failure Report.
Repair or replace the faulty components and repeat the calibration process.

4.7 Safety Precautions

Wear appropriate personal protective equipment (PPE), such as gloves and safety goggles, during calibration.
Ensure that the calibration environment is free of dust or unintended aerosols that could affect results.
Follow the equipment manual and safety guidelines for handling calibration aerosols and reference standards.

5) Abbreviations

QA: Quality Assurance
PPE: Personal Protective Equipment

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  Equipment ID  Calibration Type  Performed By  QA Approval  Remarks  
  DD/MM/YYYY  Equipment Identifier  Routine/Post-Maintenance  Technician Name  QA Name  Details of activity

Date	Equipment ID	Calibration Type	Performed By	QA Approval	Remarks
DD/MM/YYYY	Equipment Identifier	Routine/Post-Maintenance	Technician Name	QA Name	Details of activity

Annexure Title: Calibration Report

   Date  Equipment ID  Reference Particle Size  Measured Particle Size  Performed By  QA Approval  
  DD/MM/YYYY  Equipment Identifier  Standard Value  Measured Value  Technician Name  QA Name

Date	Equipment ID	Reference Particle Size	Measured Particle Size	Performed By	QA Approval
DD/MM/YYYY	Equipment Identifier	Standard Value	Measured Value	Technician Name	QA Name

Annexure Title: Calibration Failure Report

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