Pressure Gauge 0-5 bar (CAL-0070) – Calibration Documents

Calibration Documents: Pressure Gauge 0-5 bar (CAL-0070)

Asset ID CAL-0070
Equipment Pressure Gauge 0-5 bar
Equipment Type Pressure Gauge
Department Microbiology
Area/Location Sterilization
Process Use Autoclave pressure
Parameter Pressure
Units bar
Range Min 0
Range Max 5
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 0-5 bar is performed to ensure accurate measurement of pressure during the autoclave sterilization process. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Inaccurate pressure readings can lead to ineffective sterilization, potentially compromising product safety and efficacy.

2. Scope

  • Asset ID: CAL-0070
  • Equipment Name/Type: Pressure Gauge 0-5 bar / Pressure Gauge
  • Department/Area: Microbiology / Sterilization
  • Process Use: Autoclave pressure
  • Parameter: Pressure
  • Range: 0 – 5 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 an instrument meets specified requirements.
  • Adjustment: The act of modifying an instrument to bring it into alignment with a standard.
  • 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 falls outside the specified acceptance criteria.
  • Drift: The gradual change in an instrument’s output over time.
  • Traceability: The ability to trace the history, application, or location of an item through documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A periodic check of an instrument’s performance between scheduled 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 calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and properly positioned.
  • Verify power supply is stable and within required specifications.
See also  Tablet Hardness Tester (CAL-0132) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

The calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 bar and 5 bar) and midpoints (2.5 bar).
  • Replicate readings at each point: 3 repeats as a best practice.

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 initial pressure readings at specified points.
  4. Adjustment rules: If OOT is detected, follow adjustment procedures if allowed; otherwise, escalate to QA.
  5. As Left verification: Record final readings after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the reading.

Error calculation formula: Error (%) = (Observed Value – True Value) / True Value * 100

Pass/Fail logic: If the error falls 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.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as needed.
  • 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: Calibrated date, due date, by whom, 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 clean and leveled
  • Stabilization period completed
  • All readings recorded contemporaneously

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-0070 Pressure Gauge 0-5 bar Pressure Gauge Microbiology Sterilization Autoclave pressure Pressure bar 0 – 5 ±1% 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 bar
  • 25% of Range: 1.25 bar
  • 50% of Range: 2.5 bar
  • 75% of Range: 3.75 bar
  • Maximum: 5 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] ±0.01 bar [TBD] [TBD] [TBD] [TBD]
1.25 bar 1.25 bar [TBD] [TBD] ±0.0125 bar [TBD] [TBD] [TBD] [TBD]
2.5 bar 2.5 bar [TBD] [TBD] ±0.025 bar [TBD] [TBD] [TBD] [TBD]
3.75 bar 3.75 bar [TBD] [TBD] ±0.0375 bar [TBD] [TBD] [TBD] [TBD]
5 bar 5 bar [TBD] [TBD] ±0.05 bar [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the pressure gauge is clean and free from any contaminants. Verify that the calibration equipment is within its calibration date.
  2. Stabilization: Allow the pressure gauge to stabilize at room temperature for at least 30 minutes before calibration.
  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 errors against the acceptance criteria. Determine Pass/Fail status for each test point.
  6. Documentation: Complete the results table and ensure all data is recorded accurately, maintaining ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the pressure gauge 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0070 Pressure Gauge 0-5 bar Microbiology Sterilization Pressure 0 – 5 bar ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up appropriately
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for documentation

As Found Execution

  • [ ] Set the gauge to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Flow Meter (Compressed Air) (CAL-0082) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation in logbook
  • [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] 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.

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Deviation Impact Assessment

Event Summary
Asset: Pressure Gauge 0-5 bar
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: [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/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-0070 Pressure Gauge 0-5 bar Pressure Gauge Microbiology Sterilization [TBD] [TBD] [TBD] Pressure 0-5 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
1 [TBD] ±1% [TBD]
2 [TBD] ±1% [TBD]
3 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
5 [TBD] ±1% [TBD]

As Left Results

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