SOP for Calibration of Nebulizer Dosage Measurement Devices

Auditor

1 month ago

Standard Operating Procedure for Calibrating Nebulizer Dosage Measurement Devices

1) Purpose

The purpose of this SOP is to establish a standard procedure for the calibration of nebulizer dosage measurement devices to ensure accurate and consistent dosage delivery during production and testing.

2) Scope

This SOP applies to all dosage measurement devices used in the nebulizer manufacturing process, including manual and automated systems.

3) Responsibilities

Operators: Conduct preliminary checks and basic calibration procedures.
Maintenance Team: Perform advanced calibration and troubleshoot device errors.
Quality Assurance (QA): Validate the calibration results and maintain records.

4) Procedure

4.1 Pre-Calibration Preparation

Ensure the device is powered off before calibration.
Clean the device using a lint-free cloth and approved cleaning solution to remove any residue.
Check the device’s calibration status from the previous record and verify the next due date.
Gather all required tools, such as calibration weights, reference standards, and necessary documentation.

4.2 Calibration Process

Turn on the device and allow it to warm up as per the manufacturer’s guidelines.
Connect the device to a reference standard using approved adapters and connectors.
Follow the steps in the device manual to access the calibration mode.
Input the reference standard’s values into the device system.
Run the calibration process and record the

output values for each test.

Adjust settings if the output values deviate from the reference standards.

Repeat the process three times to ensure consistency and accuracy.

4.3 Post-Calibration Activities

Document the calibration results in the calibration log.
Label the device with the calibration date, next due date, and the initials of the person performing the calibration.
Perform a sample test with the calibrated device to validate its functionality.

4.4 Frequency of Calibration

Monthly: Routine calibration to ensure consistent performance.
Quarterly: Comprehensive calibration using advanced tools and methods.
Annually: Third-party calibration verification (if applicable).

5) Abbreviations

PPE: Personal Protective Equipment
QA: Quality Assurance

6) Documents

The following documents should be maintained:

Calibration Log
Device Validation Records
Error Adjustment Report

7) References

Relevant regulatory guidelines and references include:

Device Manufacturer’s Manual
ISO 13485: Medical Devices Quality Management Systems

8) SOP Version

Version: 1.0

Annexure

Annexure Title: Calibration Log for Nebulizer Dosage Measurement Devices

Date	Device Name	Reference Standard	Calibration Status	Operator Initials	Remarks
DD/MM/YYYY	Dosage Measurement Device	Standard Value	Pass/Fail	Operator Name	Details of calibration output

Annexure Title: Device Validation Records

Date	Device Name	Validation Type	Operator Initials	Supervisor Signature
DD/MM/YYYY	Dosage Measurement Device	Routine/Comprehensive	Operator Name	Supervisor Name