Pressure Gauge 0-10 bar (CAL-0071) – Calibration Documents

Calibration Documents: Pressure Gauge 0-10 bar (CAL-0071)

Asset ID CAL-0071
Equipment Pressure Gauge 0-10 bar
Equipment Type Pressure Gauge
Department Production
Area/Location Process Area
Process Use Process pressure
Parameter Pressure
Units bar
Range Min 0
Range Max 10
Acceptance Criteria ±1%
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 Pressure Gauge 0-10 bar is performed to ensure accurate measurement of process pressure within the Production department. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0071
  • Equipment Name/Type: Pressure Gauge 0-10 bar / Pressure Gauge
  • Department/Area: Production / Process Area
  • Process Use: Process pressure
  • Parameter: Pressure
  • Range: 0 – 10 bar
  • Units: bar
  • 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 alignment with a standard.
  • As Found: The condition of the instrument prior to any adjustments made during calibration.
  • As Left: The condition of the instrument after calibration and any adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in the accuracy of a measurement 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 range of values within which the true value of a measurement lies.
  • Intermediate Check: A periodic check of an instrument’s performance between calibrations.

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 for compliance.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as per the defined schedule.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up/stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment before calibration.
  • Verify power supply is stable and within required specifications.
See also  GC System (CAL-0122) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: Calibration will be traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are valid and up to date.
  • Standard ID Placeholders: [TBD]

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, 2.5, 5, 7.5, 10 bar). Each point will have three replicate readings taken to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the pressure gauge to stabilize at room temperature.
  3. As Found checks and data capture: Record the initial readings at each test point.
  4. Adjustment rules: If any readings are OOT, escalate to the QA department for further action.
  5. As Left verification: After adjustments, verify that the gauge is within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

All raw observations must be recorded contemporaneously to ensure data integrity (ALCO+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the Pressure Gauge 0-10 bar is ±1%. The error calculation formula is:

Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail logic: If the calculated error is within ±1%, the gauge passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify the QA department and initiate a deviation report.
  • Impact assessment trigger: Assess the impact on results/batches produced since the last calibration.
  • Recalibration after repair/adjustment: Ensure recalibration is performed after any adjustments.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries must include calibration date, due date, technician name, and status.
  • Calibration report/certificate filing must be maintained for audit purposes.
  • E-records if applicable: [TBD]

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

  • Equipment clean and ready for calibration.
  • All necessary tools and standards available.
  • Calibration environment controlled.
  • Calibration schedule adhered to.

Annexure C: Example Label Text

Calibration Date: [TBD]

See also  Torque Tester (Cap torque) (CAL-0265) - Calibration Documents

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-0071 Pressure Gauge 0-10 bar Pressure Gauge Production Process Area Process pressure Pressure bar 0 – 10 ±1% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 bar
  • 25% of Range: 2.5 bar
  • 50% of Range: 5 bar
  • 75% of Range: 7.5 bar
  • Maximum: 10 bar

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 bar 0 bar [TBD] [TBD] ±0.1 bar [TBD] [TBD] [TBD] [TBD]
2.5 bar 2.5 bar [TBD] [TBD] ±0.025 bar [TBD] [TBD] [TBD] [TBD]
5 bar 5 bar [TBD] [TBD] ±0.05 bar [TBD] [TBD] [TBD] [TBD]
7.5 bar 7.5 bar [TBD] [TBD] ±0.075 bar [TBD] [TBD] [TBD] [TBD]
10 bar 10 bar [TBD] [TBD] ±0.1 bar [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the pressure gauge is clean and free from any obstructions. Verify that the calibration equipment is available and functioning.
  2. Stabilization: Allow the pressure gauge to stabilize at room temperature for at least [TBD] minutes before calibration.
  3. Performing Readings: Apply pressure at each test point. Take three replicate readings at each point and record the values.
  4. Calculating Error: For each test point, calculate the error as: Error = Observed Value – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±1% of the full scale.
  6. Documentation: Complete the results table with all observed values and errors. Ensure all data is recorded accurately to maintain ALCOA+ principles.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the pressure gauge immediately.
  • Notify the supervisor and QA department.
  • 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-0071 Pressure Gauge 0-10 bar Production Process Area Pressure 0 – 10 bar ±1% 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 necessary
  • [ ] Ensure the equipment is leveled
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for documentation
See also  Friability Tester (CAL-0134) - Calibration Documents

As Found Execution

  • [ ] Set the gauge to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label
  • [ ] Attach calibration certificate
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

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Deviation Impact Assessment

Event Summary Details
Asset Pressure Gauge 0-10 bar
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the equipment
  • Label/Tag the equipment as out of service
  • 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/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-0071 Pressure Gauge 0-10 bar Pressure Gauge Production Process Area [TBD] [TBD] [TBD] Pressure / 0-10 / bar ±1%

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 (bar) Deviation
0 [TBD] [TBD]
2 [TBD] [TBD]
4 [TBD] [TBD]
6 [TBD] [TBD]
8 [TBD] [TBD]
10 [TBD] [TBD]

As Left Results

Test Point Measured Value (bar) Deviation
0 [TBD] [TBD]
2 [TBD] [TBD]
4 [TBD] [TBD]
6 [TBD] [TBD]
8 [TBD] [TBD]
10 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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