Inline Conductivity Sensor (WFI) (CAL-0095) – Calibration Documents

Calibration Documents: Inline Conductivity Sensor (WFI) (CAL-0095)

Asset ID CAL-0095
Equipment Inline Conductivity Sensor (WFI)
Equipment Type Inline Conductivity Sensor
Department Utilities
Area/Location WFI Loop
Process Use Conductivity
Parameter Conductivity
Units µS/cm
Range Min 0
Range Max 2000
Acceptance Criteria ±1%
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 Inline Conductivity Sensor (WFI) is performed to ensure accurate measurement of conductivity, which is critical for maintaining the quality of Water for Injection (WFI). This calibration controls risks related to patient safety, batch quality, and data integrity by ensuring that the sensor operates within specified limits.

2. Scope

  • Asset ID: CAL-0095
  • Equipment Name/Type: Inline Conductivity Sensor (WFI)
  • Department/Area: Utilities / WFI Loop
  • Process Use: Conductivity
  • Parameter: Conductivity
  • Range: 0 – 2000 µS/cm
  • Units: µS/cm
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to ensure 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.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement exceeds specified limits.
  • 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 continued accuracy.

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 results and documentation.
  • 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 for warm-up/stabilization of the sensor as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
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7. Standards & Tools

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

8. Calibration Strategy

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

  • Minimum number of points: At least 5 points including endpoints (0, 2000 µS/cm) and midpoints.
  • Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the Inline Conductivity Sensor to stabilize as per manufacturer recommendations.
  3. As Found checks and data capture: Record initial readings and conditions.
  4. Adjustment rules: If OOT is found, follow escalation procedures; adjustments are only allowed if specified.
  5. As Left verification: Confirm that the sensor is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

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

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1%

Error calculation formula: Error (%) = (Measured Value – True Value) / True Value × 100

Pass/Fail Logic: If the error falls within ±1%, the calibration is considered a pass.

Rounding rule: [TBD]

11. Handling OOT / Failures

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

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with 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 clean and leveled
  • Power supply checked
  • Calibration standards available

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-0095 Inline Conductivity Sensor (WFI) Inline Conductivity Sensor Utilities WFI Loop Conductivity Conductivity µS/cm 0 – 2000 ±1% 180 days External ISO17025
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Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 µS/cm
  • 25% of Range: 500 µS/cm
  • 50% of Range: 1000 µS/cm
  • 75% of Range: 1500 µS/cm
  • Maximum: 2000 µS/cm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 µS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
500 µS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
1000 µS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
1500 µS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2000 µS/cm [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Inline Conductivity Sensor is clean and properly installed in the WFI Loop.
  2. Stabilization: Allow the sensor to stabilize for at least [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±1%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any reading falls outside the acceptance criteria:

  • Stop use of the Inline Conductivity Sensor.
  • Notify the supervisor immediately.
  • Open a deviation report.
  • Quarantine 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-0095 Inline Conductivity Sensor (WFI) Utilities WFI Loop Conductivity 0 – 2000 µS/cm ±1% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure sensor has warmed up for the required duration
  • [ ] Clean the sensor as per SOP
  • [ ] Level the sensor installation if applicable
  • [ ] Confirm reference standards are valid and calibrated
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the sensor to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel of the OOT condition
  • [ ] Document deviation and investigation steps
  • [ ] Trigger impact review as per SOP
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As Left Verification

  • [ ] Conduct post-adjustment checks to confirm accuracy
  • [ ] Ensure all measurements are within specified limits

Documentation & Closure

  • [ ] Update calibration label with new date
  • [ ] Attach calibration certificate to log
  • [ ] Obtain reviewer sign-off on calibration documentation
  • [ ] Update next due date in the logbook

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

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Deviation Impact Assessment

Event Summary Details
Asset Inline Conductivity Sensor (WFI)
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/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-0095 Inline Conductivity Sensor (WFI) Inline Conductivity Sensor Utilities WFI Loop [TBD] [TBD] [TBD] Conductivity / 0 – 2000 / µS/cm ±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 (µS/cm) 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 (µS/cm) 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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