Differential Pressure Gauge 0-250 Pa (CAL-0076) – Calibration Documents

Calibration Documents: Differential Pressure Gauge 0-250 Pa (CAL-0076)

Asset ID CAL-0076
Equipment Differential Pressure Gauge 0-250 Pa
Equipment Type Diff Pressure Gauge
Department HVAC
Area/Location Cleanroom
Process Use Room DP
Parameter Differential Pressure
Units Pa
Range Min 0
Range Max 250
Acceptance Criteria ±5 Pa
Calibration Frequency (days) 180
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Differential Pressure Gauge 0-250 Pa is performed to ensure accurate measurement of differential pressure within the cleanroom environment. This is critical for maintaining compliance with Good Manufacturing Practices (GMP) and ensuring patient safety, batch quality, and data integrity. Accurate readings help prevent deviations that could impact product quality and safety.

2. Scope

  • Asset ID: CAL-0076
  • Equipment Name/Type: Differential Pressure Gauge 0-250 Pa / Diff Pressure Gauge
  • Department/Area: HVAC / Cleanroom
  • Process Use: Room DP
  • Parameter: Differential Pressure
  • Range: 0 – 250 Pa
  • Units: Pa
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the defined acceptance criteria.
  • Drift: The gradual change in the measurement output of an instrument over time.
  • Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A check performed between calibrations to ensure the instrument remains within specified limits.

4. References

  • Company Metrology SOP [TBD]
  • ISO/IEC 17025 traceability via calibration certificates
  • ALCOA+ principles

5. Responsibilities

  • Technician/Metrology: Perform calibration and maintain records.
  • QC/QA Reviewer: Review calibration records and ensure compliance.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer recommendations.
  • Maintain cleanliness in the calibration area.
  • Check leveling of the equipment before calibration.
  • Verify power supply is stable and within specifications.
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7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current and valid.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints of the range (0, 62.5, 125, 187.5, 250 Pa). Each point will have three replicate readings to ensure accuracy, unless otherwise specified.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the gauge to stabilize in the calibration environment.
  3. As Found checks and data capture: Record initial readings at each test point.
  4. Adjustment rules: If any reading is OOT, follow the adjustment protocol; if not allowed, escalate the issue.
  5. As Left verification: Record final readings after any adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously, adhering to ALCOA+ principles.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Differential Pressure Gauge is ±5 Pa. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of the error is within acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel and document the deviation.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Maintain detailed logs of all calibration activities.
  • Calibration report/certificate filing: Store all calibration certificates securely.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Points Reference Observed Error Acceptance Pass/Fail As Found As Left
0 Pa [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
62.5 Pa [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
125 Pa [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
187.5 Pa [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
250 Pa [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Annexure B: Quick Checklist

  • Environmental controls verified
  • Equipment warmed up and stabilized
  • Calibration area cleaned
  • Equipment leveled
  • Power supply checked

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

See also  Hot Air Oven Temp Sensor (CAL-0154) - Calibration Documents

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Calibration Protocol

Calibration Protocol

Protocol ID Asset ID Equipment Name Equipment Type Dept Area Process Use Parameter Units Range Acceptance Criteria Frequency Calibration Type Traceability
[TBD] CAL-0076 Differential Pressure Gauge 0-250 Pa Diff Pressure Gauge HVAC Cleanroom Room DP Differential Pressure Pa 0 – 250 ±5 Pa 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 Pa
  • 25% of Range: 62.5 Pa
  • 50% of Range: 125 Pa
  • 75% of Range: 187.5 Pa
  • Maximum: 250 Pa

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 Pa 0 Pa [TBD] [TBD] ±5 Pa [TBD] [TBD] [TBD] [TBD]
62.5 Pa 62.5 Pa [TBD] [TBD] ±5 Pa [TBD] [TBD] [TBD] [TBD]
125 Pa 125 Pa [TBD] [TBD] ±5 Pa [TBD] [TBD] [TBD] [TBD]
187.5 Pa 187.5 Pa [TBD] [TBD] ±5 Pa [TBD] [TBD] [TBD] [TBD]
250 Pa 250 Pa [TBD] [TBD] ±5 Pa [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the differential pressure gauge is clean and calibrated within the last 180 days.
  2. Stabilization: Allow the gauge to stabilize for at least 30 minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each reading as follows: Error = Observed Value – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±5 Pa.
  6. Documentation: Record all observed values, errors, and pass/fail results in the results table.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • Open a deviation report.
  • Quarantine the impacted results window: [TBD].
  • Await QA decision on further actions.

Approvals

Prepared Reviewed Approved
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0076 Differential Pressure Gauge 0-250 Pa HVAC Cleanroom Differential Pressure 0 – 250 Pa ±5 Pa 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results
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OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel of OOT condition
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all measurements are within acceptance limits

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] Attach calibration certificate to logbook
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date for calibration

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate.

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Deviation Impact Assessment

Event Summary Details
Asset Differential Pressure Gauge 0-250 Pa
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the asset
  • Label/tag the asset as out of tolerance
  • Segregate impacted work

Define Impact Window

Last Known In-Tolerance Date Discovery Date
[TBD] [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID Results Potentially Impacted Re-Test/Re-Weigh Decision
[TBD] [TBD] [TBD]

Data Integrity Review Prompts (ALCOA+)

  • Attributable: [TBD]
  • Legible: [TBD]
  • Contemporaneous: [TBD]
  • Original: [TBD]
  • Accurate: [TBD]
  • Complete: [TBD]
  • Consistent: [TBD]
  • Enduring: [TBD]
  • Available: [TBD]

Risk Assessment

Severity Probability Detectability Rationale Overall Risk
[TBD] [TBD] [TBD] [TBD] [TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Re-Test/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID Equipment Name Equipment Type Dept Area Make/Model Serial No Location Parameter/Range/Units Acceptance Criteria
CAL-0076 Differential Pressure Gauge 0-250 Pa Diff Pressure Gauge HVAC Cleanroom [TBD] [TBD] [TBD] Differential Pressure (0-250 Pa) ±5 Pa

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Measured Value (Pa) Acceptance Criteria Pass/Fail
1 [TBD] ±5 Pa [TBD]
2 [TBD] ±5 Pa [TBD]
3 [TBD] ±5 Pa [TBD]
4 [TBD] ±5 Pa [TBD]
5 [TBD] ±5 Pa [TBD]

As Left Results

Test Point Measured Value (Pa) Acceptance Criteria Pass/Fail
1 [TBD] ±5 Pa [TBD]
2 [TBD] ±5 Pa [TBD]
3 [TBD] ±5 Pa [TBD]
4 [TBD] ±5 Pa [TBD]
5 [TBD] ±5 Pa [TBD]

Measurement Uncertainty Statement

[TBD]

Statement of Conformity

[TBD]

Remarks

[TBD]

Signatures

Performed by: ____________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: _____________________ Date: ____________

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