Manometer (U-tube/Digital) (CAL-0078) – Calibration Documents

Calibration Documents: Manometer (U-tube/Digital) (CAL-0078)

Asset ID CAL-0078
Equipment Manometer (U-tube/Digital)
Equipment Type Manometer
Department HVAC
Area/Location Cleanroom
Process Use DP verification
Parameter Pressure
Units Pa
Range Min 0
Range Max 500
Acceptance Criteria ±5 Pa
Calibration Frequency (days) 365
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 Manometer (U-tube/Digital) is performed to ensure accurate pressure measurements within the Cleanroom environment. This calibration controls risks associated with inaccurate pressure readings that could compromise patient safety, batch quality, and overall data integrity.

2. Scope

  • Asset ID: CAL-0078
  • Equipment Name/Type: Manometer (U-tube/Digital)
  • Department/Area: HVAC / Cleanroom
  • Process Use: DP verification
  • Parameter: Pressure
  • Range: 0 to 500 Pa
  • Units: Pa
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against 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 specifications.
  • 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 specified acceptance criteria.
  • Drift: The gradual change in a measurement instrument’s output 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 range of values within which the true value is asserted to lie.
  • Intermediate Check: A check performed between calibrations to ensure ongoing accuracy.

4. References

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

5. Responsibilities

  • Technician/Metrology: Perform calibration and document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • Owner Department: Ensure equipment is available and accessible for calibration.
  • External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment warm-up/stabilization time as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level before calibration.
  • Verify power supply is stable and within specifications.
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7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: Ensure all certificates are current and valid.
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints within the specified range of 0 to 500 Pa. It is recommended to take three replicate readings at each point to ensure accuracy, unless otherwise specified.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the manometer to stabilize in the calibration environment.
  3. As Found checks and data capture: Record initial readings at defined points.
  4. Adjustment rules: If OOT is detected, follow escalation procedures as adjustments may not be allowed.
  5. As Left verification: After any adjustments, verify and record the final readings.
  6. Labeling + documentation completion: Ensure all calibration records are completed and labeled appropriately.

Record raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±5 Pa

Error calculation formula: Error = Observed Value – True Value

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

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

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

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records as per company policy.
  • 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
[TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Annexure B: Quick Checklist

  • Environmental controls verified
  • Equipment warm-up completed
  • Cleanliness confirmed
  • Leveling checked
  • Power supply stable

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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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-0078 Manometer (U-tube/Digital) Manometer HVAC Cleanroom DP verification Pressure Pa 0 – 500 ±5 Pa 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 Pa
  • 25% of Range: 125 Pa
  • 50% of Range: 250 Pa
  • 75% of Range: 375 Pa
  • Maximum: 500 Pa

Results Table

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

Stepwise Instructions

  1. Preparation: Ensure the manometer is clean and calibrated prior to use. Verify that the calibration equipment is within its calibration date.
  2. Stabilization: Allow the manometer to stabilize in the cleanroom environment for at least 30 minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point. Record all observed values.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed Value – Reference Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±5 Pa.
  6. Documentation: Complete the results table and ensure all data is recorded accurately following ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).

Deviation Instruction for OOT

If any observed value exceeds the acceptance criteria:

  • Stop use of the manometer.
  • Notify the supervisor immediately.
  • Open a deviation report.
  • Quarantine impacted results window: [TBD]
  • Await QA decision on further actions.

Approvals

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

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0078 Manometer (U-tube/Digital) HVAC Cleanroom Pressure 0 – 500 Pa ±5 Pa 365 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 manometer before calibration
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the initial pressure setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for analysis
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OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the manometer
  • [ ] Notify the supervisor/QA
  • [ ] Document the deviation
  • [ ] Trigger impact review process

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 in logbook

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

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Deviation Impact Assessment

Event Summary Details
Asset Manometer (U-tube/Digital)
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

Summary of investigation findings: [TBD]

Root Cause: [TBD]

CAPA Plan

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

QA Disposition

Release/Hold/Retest/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-0078 Manometer (U-tube/Digital) Manometer HVAC Cleanroom [TBD] [TBD] [TBD] Pressure (0 – 500 Pa) ±5 Pa

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (Pa) Remarks
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (Pa) Remarks
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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