Inline Conductivity Sensor (PW) (CAL-0094) – Calibration Documents

Calibration Documents: Inline Conductivity Sensor (PW) (CAL-0094)

Asset ID CAL-0094
Equipment Inline Conductivity Sensor (PW)
Equipment Type Inline Conductivity Sensor
Department Utilities
Area/Location PW 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 (PW) is performed to ensure accurate measurement of conductivity within the PW Loop. This is critical for maintaining patient safety, ensuring batch quality, and upholding data integrity. Accurate conductivity readings are essential for compliance with Good Manufacturing Practices (GMP) and to mitigate risks associated with product quality and safety.

2. Scope

  • Asset ID: CAL-0094
  • Equipment Name/Type: Inline Conductivity Sensor (PW)
  • Department/Area: Utilities
  • 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 device against a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement device operates within specified limits.
  • Adjustment: The process of modifying a measurement device to bring it into compliance with specified standards.
  • As Found: The condition of the measurement device prior to any adjustments.
  • As Left: The condition of the measurement device after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement device’s output falls outside the defined acceptance criteria.
  • Drift: The gradual change in the output of a measurement device 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 a measurement device to ensure it remains within specified limits between calibrations.

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 compliance with calibration schedule.
  • 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 sensor installation.
  • Verify power supply stability and functionality.
See also  Multimeter (CAL-0270) - Calibration Documents

7. Standards & Tools

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

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 specified range (0 – 2000 µS/cm). Each point will have three replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the Inline Conductivity Sensor to stabilize as per manufacturer instructions.
  3. As Found checks and data capture: Record initial readings at defined test points.
  4. Adjustment rules: If OOT is detected, follow escalation procedures for adjustment.
  5. As Left verification: Confirm that the sensor is within tolerance after adjustments.
  6. Labeling + documentation completion: Ensure all records are completed and raw observations are recorded contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the Inline Conductivity Sensor is ±1%. The error calculation formula is as follows:

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

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

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use until resolved.
  • Notification & deviation initiation: Notify QA and initiate deviation process.
  • Impact assessment trigger: Assess the impact on results/batches within the defined impact window.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries must include all calibration activities.
  • Calibration report/certificate filing must be maintained for audit purposes.
  • 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 clean and leveled
  • Power supply checked
  • Calibration standards available

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

See also  UPLC System (CAL-0121) - Calibration Documents

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-0094 Inline Conductivity Sensor (PW) Inline Conductivity Sensor Utilities PW Loop Conductivity Conductivity µS/cm 0 – 2000 ±1% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

  • 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] ±1% [TBD] [TBD] [TBD] [TBD]
500 µS/cm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
1000 µS/cm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
1500 µS/cm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
2000 µS/cm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Inline Conductivity Sensor is clean and properly installed in the PW Loop.
  2. Stabilization: Allow the sensor to stabilize for [TBD] minutes before taking readings.
  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 error against the acceptance criteria of ±1%.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

If any reading is out of tolerance (OOT):

  • 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-0094 Inline Conductivity Sensor (PW) Utilities PW Loop Conductivity 0 – 2000 µS/cm ±1% 180 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Record initial setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Manometer (U-tube/Digital) (CAL-0078) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

  • [ ] Perform post-adjustment checks
  • [ ] Confirm measurements 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. Maintain compliance with GxP standards.

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Deviation Impact Assessment

Event Summary
Asset: Inline Conductivity Sensor (PW)
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-0094 Inline Conductivity Sensor (PW) Inline Conductivity Sensor Utilities PW 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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