SOP Guide for Pharma

Aerosol: SOP for Calibration of Pressure Gauges in Utility Systems – V 2.0

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Aerosol: SOP for Calibration of Pressure Gauges in Utility Systems – V 2.0

SOP for Calibration of Pressure Gauges in Utility Systems

Department Aerosol
SOP No. SOP/Aerosol/144/2025
Supersedes SOP/Aerosol/144/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the calibration of pressure gauges used in utility systems in aerosol manufacturing. Pressure gauges are critical instruments in monitoring and maintaining proper operating conditions, ensuring that pressure levels are within the required range for safe and efficient manufacturing operations. This SOP ensures that pressure gauges are accurately calibrated to maintain the reliability and accuracy of pressure measurements, contributing to product quality and safety compliance.

2. Scope

This SOP applies to all pressure gauges used in utility systems involved in aerosol manufacturing, including systems for water, air, gas, and steam. It covers the calibration process, including the procedures for verification, adjustment, and documentation to ensure that all pressure gauges meet the specified calibration standards.

3. Responsibilities

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4. Accountability

The Manufacturing Manager is accountable for ensuring that all pressure gauges are calibrated according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Calibration

  1. Ensure that the pressure gauge is free from damage and functioning properly. Verify that the gauge is connected to the utility system and is in the appropriate condition for calibration.
  2. Verify that the necessary calibration equipment is available and properly calibrated. This includes comparison standards, calibration kits, and pressure sources such as hand pumps or calibration rigs.
  3. Review the manufacturer’s specifications for the pressure gauge to determine the calibration range and tolerances required for the specific application.
  4. Establish the calibration team, which should include representatives from the Engineering, Maintenance, and QA teams. Ensure that personnel are trained in calibration procedures and understand the required standards.
  5. Ensure that the calibration area is clean and free of any contaminants that could affect the calibration process. All instruments and equipment should be properly labeled and easily identifiable.

5.2. Performing the Calibration

  1. Begin the calibration process by verifying the zero reading of the pressure gauge. This ensures that the gauge reads accurately when there is no pressure applied.
  2. Apply a known reference pressure to the gauge being calibrated. Use a calibrated pressure source, such as a pressure calibrator or dead weight tester, to ensure that the applied pressure is accurate.
  3. Record the reading on the pressure gauge at multiple pressure points within the specified range. Compare the gauge’s readings with the reference pressure and verify that they are within the acceptable tolerance limits.
  4. If the readings are outside the tolerance limits, adjust the pressure gauge according to the manufacturer’s instructions to bring it into alignment with the reference pressure.
  5. Repeat the process for multiple pressure points (e.g., low, medium, and high pressure) to ensure accuracy across the entire range of the pressure gauge.
  6. If the pressure gauge cannot be calibrated to the specified tolerance limits, report the issue and remove the gauge from service for repair or replacement.
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5.3. Documenting the Calibration Results

  1. Document the calibration results in the Calibration Record (Annexure-1). The record should include the following information:
    • Pressure gauge ID, model number, serial number, and location
    • Calibration date and time
    • The reference pressure values applied during calibration and the readings of the gauge at each pressure point
    • Any deviations observed during calibration and corrective actions taken (if applicable)
    • The name and signature of the personnel performing the calibration
    • Approval signatures from the QA team
  2. Ensure that all calibration results are accurate, complete, and easy to review. Any deviations from the expected results should be thoroughly documented and addressed.

5.4. Reviewing and Approving the Calibration Report

  1. The QA team should review the Calibration Record to ensure that all calibration activities were performed according to this SOP and that the gauge is operating within the specified tolerance limits.
  2. If any deviations were observed during calibration, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken to address the issue.
  3. The QA team should approve the calibration report once all tests are complete and any deviations have been addressed.

5.5. Finalizing the Calibration Process

  1. Once the calibration is complete, the pressure gauge is returned to service and marked with the calibration date and the next due date for re-calibration.
  2. Ensure that all documentation, including the Calibration Record, Deviation Log, and any corrective actions, is archived for future audits and inspections.
  3. Periodic re-calibration of pressure gauges should be scheduled as per the manufacturer’s recommendations or regulatory requirements to ensure continuous accuracy.
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6. Abbreviations

7. Documents

  1. Calibration Record (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Corrective Action Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Record

Gauge ID Model Number Serial Number Test Date Pressure Point (psi) Gauge Reading (psi) Deviation Corrective Action
PG-001 Model A SN123456 06/02/2025 30 29.8 0.2 psi Adjust calibration
PG-001 Model A SN123456 06/02/2025 60 59.9 0.1 psi Adjust calibration

Annexure-2: Deviation Log

Deviation ID Deviation Description Corrective Action Assigned To Status
DEV-12345 Pressure deviation at 30 psi Recalibrated gauge Rajesh Patel Completed

Annexure-3: Corrective Action Log

Action ID Action Description Responsible Person Completion Date
CA-12345 Recalibrated pressure gauge Rajesh Patel 06/02/2025

12. Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 V 1.0 Initial Release First Issue Anjali Sharma Page 1 [Ref Point] First Release
01/01/2025 V 2.0 Updated calibration procedures To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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