Standard Operating Procedure for Calibrating Spray Rate Measurement Equipment for Nebulizers

1) Purpose

The purpose of this SOP is to establish a standardized procedure for calibrating spray rate measurement equipment to ensure accurate and reliable performance during nebulizer production.

2) Scope

This SOP applies to all spray rate measurement equipment used in the quality control and validation of nebulizer devices within the manufacturing facility.

3) Responsibilities

Operators: Assist with equipment setup and calibration activities.
Maintenance Team: Perform calibration and troubleshoot equipment issues.
Quality Assurance (QA): Validate calibration results and approve records.

4) Procedure

4.1 Pre-Calibration Checks

• Ensure the spray rate measurement equipment is clean and free of debris or residues.
• Inspect the equipment for physical damage or wear, such as cracks, loose components, or blocked nozzles.
• Verify the calibration equipment (e.g., precision flow meters or gravimetric balances) is within its calibration validity period.
• Document the equipment details, including model number, serial number, and location, in the Calibration Log.

4.2 Calibration Setup

• Connect the nebulizer device to the spray rate measurement equipment using approved adapters or fixtures.
• Prepare a standard solution or fluid for testing as per the product specification.
• Set up the calibration equipment, ensuring it is securely connected and all required tools and materials are readily available.

4.3 Calibration Process

• Start the nebulizer device and allow it to stabilize for the duration specified in the operational manual.
• Measure the spray rate output using the calibration equipment over defined intervals, such as 30 seconds or 1 minute.
• Record the measured values and compare them with the expected spray rate specifications provided by the equipment manufacturer or product design.
• If deviations exceed the acceptable tolerance range, adjust the spray rate measurement equipment settings according to the calibration protocol.

4.4 Post-Calibration Verification

• Repeat the measurement process after adjustments to confirm the accuracy of the equipment.
• Document all pre- and post-calibration readings in the Spray Rate Calibration Report.
• Label the equipment with the calibration date, next due date, and technician initials.

4.5 Frequency of Calibration

• Routine Calibration: Biannually or as recommended by the manufacturer.
• Post-Maintenance Calibration: After any repairs or replacement of critical components.
• Annual Calibration: Comprehensive calibration performed by an external certified agency.

4.6 Handling Calibration Failures

• In the event of calibration failure, isolate the affected equipment and inform the QA team immediately.
• Document the failure details in the Calibration Failure Report and initiate corrective actions.
• Do not use the equipment until it is recalibrated and approved by QA.

5) Abbreviations

• QA: Quality Assurance
• PPE: Personal Protective Equipment

6) Documents

The following documents should be maintained:

• Spray Rate Calibration Log
• Spray Rate 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: Spray Rate Calibration Log

Date	Equipment ID	Measured Spray Rate	Standard Spray Rate	Performed By	Remarks
DD/MM/YYYY	Equipment Identifier	Measured Value (mL/min)	Standard Value (mL/min)	Technician Name	Details of Calibration

Annexure Title: Spray Rate Calibration Report

Date	Equipment ID	Pre-Calibration Reading	Post-Calibration Reading	Performed By	QA Approval
DD/MM/YYYY	Equipment Identifier	Pre-Reading (mL/min)	Post-Reading (mL/min)	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	Issue Description	Corrective Steps	Technician Name	QA Name