SOP for Calibration of Nebulizer Ultrasonic Cleaning Equipment

Standard Operating Procedure for Calibrating Nebulizer Ultrasonic Cleaning Equipment

1) Purpose

The purpose of this SOP is to outline the calibration process for nebulizer ultrasonic cleaning equipment to ensure its effectiveness and consistency in cleaning components as per required standards.

2) Scope

This SOP applies to all ultrasonic cleaning equipment used in the cleaning processes during the manufacturing of nebulizer components within the facility.

3) Responsibilities

Operators: Assist in calibration setup and document readings.
Maintenance Team: Perform calibration and ensure proper functioning of the equipment.
Quality Assurance (QA): Validate calibration results and approve calibration records.
Supervisors: Oversee the calibration process and ensure compliance with the SOP.

4) Procedure

4.1 Pre-Calibration Checks

Inspect the ultrasonic cleaner for physical damage, dirt, or residues from previous operations.
Ensure the cleaning solution reservoir is empty and cleaned.
Verify that all calibration instruments, such as frequency meters and watt meters, are within their calibration validity period.
Document the equipment details, such as model and serial number, in the Calibration Log.

4.2 Calibration Setup

Fill the ultrasonic cleaner’s reservoir with deionized water or a calibration-specific solution.
Insert the calibration instruments into the cleaning chamber as per the manufacturer’s instructions.
Set the equipment to the specified frequency and power

settings for calibration.

Ensure a stable power supply and proper grounding of the equipment.

4.3 Calibration Procedure

Activate the ultrasonic cleaner and allow it to run for a warm-up period as specified in the manufacturer’s guidelines.
Measure the frequency and power output using the calibration instruments and compare the readings with the equipment’s specifications.
Verify the uniformity of ultrasonic waves by placing foil strips or a cavitation meter in different areas of the cleaning tank.
Record all readings and note any deviations from the acceptable range.
If deviations exceed allowable limits, adjust the equipment settings and repeat the calibration process.

4.4 Post-Calibration Activities

Drain the calibration solution from the tank and clean the reservoir thoroughly.
Label the ultrasonic cleaner with the calibration status, date, and next due date.
Submit the calibration results to the QA team for validation and approval.
Document the calibration activity in the Calibration Log and file a copy of the Calibration Report.

4.5 Frequency of Calibration

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

4.6 Handling Calibration Failures

Isolate the equipment if calibration fails and report the issue to the maintenance team.
Document the failure details in the Calibration Failure Report and notify the QA team.
Rectify the issue and repeat the calibration process before using the equipment.

4.7 Safety Precautions

Wear appropriate personal protective equipment (PPE), such as gloves and safety goggles, during calibration activities.
Ensure that the equipment is disconnected from the power supply when inserting or removing calibration instruments.
Handle electrical components and calibration instruments with care to avoid damage or injury.

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  Frequency (kHz)  Power Output (W)  Performed By  Remarks  
  DD/MM/YYYY  Equipment Identifier  Frequency Measured  Power Measured  Technician Name  Details of calibration

Date	Equipment ID	Frequency (kHz)	Power Output (W)	Performed By	Remarks
DD/MM/YYYY	Equipment Identifier	Frequency Measured	Power Measured	Technician Name	Details of calibration

Annexure Title: Calibration Report

   Date  Equipment ID  Pre-Calibration Reading  Post-Calibration Reading  Performed By  QA Approval  
  DD/MM/YYYY  Equipment Identifier  Details of pre-readings  Details of post-readings  Technician Name  QA Name

Date	Equipment ID	Pre-Calibration Reading	Post-Calibration Reading	Performed By	QA Approval
DD/MM/YYYY	Equipment Identifier	Details of pre-readings	Details of post-readings	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  Details of issue  Details of corrective action  Technician Name  QA Name

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