Steam Pressure Gauge (CAL-0323) – Calibration Documents

Calibration Documents: Steam Pressure Gauge (CAL-0323)

Asset ID CAL-0323
Equipment Steam Pressure Gauge
Equipment Type Pressure Gauge
Department Utilities
Area/Location Steam
Process Use Pressure
Parameter Pressure
Units bar
Range Min 0
Range Max 16
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 Steam Pressure Gauge (CAL-0323) is performed to ensure accurate pressure measurements within the steam utility system. 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-0323
Equipment Name/Type: Steam Pressure Gauge / Pressure Gauge
Department/Area: Utilities / Steam
Process Use: Pressure
Parameter: Pressure
Range: 0 to 16 bar
Units: bar
Calibration Frequency: 365 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.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement is outside the specified acceptance criteria.
  • Drift: The gradual change in the output 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 is asserted to lie.
  • Intermediate Check: A verification process conducted 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 required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer guidelines.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the equipment before calibration.
  • Verify power supply stability and functionality.
See also  Autoclave Pressure Gauge (CAL-0151) - Calibration Documents

7. Standards & Tools

Reference Standards Required: [TBD]
Traceability Statement: Calibration is traceable to ISO17025 standards.
Certificate Validity Check: Ensure all calibration certificates are current and valid.

8. Calibration Strategy

Calibration will follow an As Found and As Left logic. The minimum number of calibration points will be five, including endpoints and midpoints, across the range of 0 to 16 bar. Each point will have three replicate readings taken as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Steam Pressure Gauge to stabilize before taking measurements.
  3. As Found checks and data capture: Record initial readings at defined points.
  4. Adjustment rules: If OOT is found, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Confirm readings post-adjustment to ensure compliance.
  6. Labeling + documentation completion: Label the equipment and complete all required documentation contemporaneously, ensuring ALCOA+ principles are followed.

10. Acceptance Criteria & Calculations

Acceptance Criteria: ±1% of the measured value.
Error Calculation Formula: Error (%) = [(Observed Value – True Value) / True Value] x 100.
Pass/Fail Logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.
Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define the 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 must include calibration report/certificate filing. E-records if applicable [TBD].
Label Content Requirements: 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]

⬆ Back to TOC

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-0323 Steam Pressure Gauge Pressure Gauge Utilities Steam Pressure Pressure bar 0 – 16 ±1% 365 days External ISO17025
See also  Steam Temperature Sensor (CAL-0324) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Min: 0 bar
  • 25%: 4 bar
  • 50%: 8 bar
  • 75%: 12 bar
  • Max: 16 bar

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
4 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
8 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
12 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
16 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Steam Pressure Gauge is clean and free from any obstructions.
  2. Stabilization: Allow the gauge to stabilize at room temperature for at least 30 minutes before calibration.
  3. Performing Readings: Take readings at each test point. Record at least three replicates for each point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated error to the acceptance criteria of ±1%.
  6. Documentation: Complete the results table with all observed values and errors.

Deviation Instruction for OOT

If any observed value is out of tolerance (OOT):

  • Stop use of the equipment immediately.
  • Notify the 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]

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0323 Steam Pressure Gauge Utilities Steam Pressure 0 – 16 bar ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environment conditions are within specifications
  • [ ] Ensure equipment has warmed up as per SOP
  • [ ] Clean the equipment as required
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the gauge to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Compound Gauge (-1 to 10 bar) (CAL-0074) - Calibration Documents

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 readings are within acceptance limits

Documentation & Closure

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

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

⬆ Back to TOC

Deviation Impact Assessment

Event Summary
Asset: Steam Pressure Gauge
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 tolerance
  • Segregate impacted work

Define Impact Window

Last known in-tolerance date: [TBD] to discovery date: [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]

⬆ Back to TOC

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-0323 Steam Pressure Gauge Pressure Gauge Utilities Steam [TBD] [TBD] [TBD] Pressure (0-16 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) Acceptance Criteria Pass/Fail
0 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
8 [TBD] ±1% [TBD]
12 [TBD] ±1% [TBD]
16 [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (bar) Acceptance Criteria Pass/Fail
0 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
8 [TBD] ±1% [TBD]
12 [TBD] ±1% [TBD]
16 [TBD] ±1% [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: _____________________ Date: ___________

⬆ Back to TOC