Dissolved Oxygen Sensor (Bioreactor) (CAL-0098) – Calibration Documents

Calibration Documents: Dissolved Oxygen Sensor (Bioreactor) (CAL-0098)

Asset ID CAL-0098
Equipment Dissolved Oxygen Sensor (Bioreactor)
Equipment Type DO Sensor
Department Biologics
Area/Location Bioreactor
Process Use DO control
Parameter Dissolved Oxygen
Units %DO
Range Min 0
Range Max 200
Acceptance Criteria ±2%
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 Dissolved Oxygen Sensor (Bioreactor) is performed to ensure accurate measurement of dissolved oxygen levels, which is critical for maintaining optimal conditions in bioprocessing. This calibration controls risks associated with inaccurate readings that could compromise patient safety, batch quality, and data integrity.

2. Scope

  • Asset ID: CAL-0098
  • Equipment Name/Type: Dissolved Oxygen Sensor (DO Sensor)
  • Department/Area: Biologics/Bioreactor
  • Process Use: DO control
  • Parameter: Dissolved Oxygen
  • Range: 0 – 200 %DO
  • Units: %DO
  • Calibration Frequency: 180 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 is functioning correctly.
  • Adjustment: The act of correcting a measurement instrument to ensure it meets 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 falls 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 expected to lie.
  • Intermediate Check: A periodic check performed to ensure the instrument 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • Owner Department: Ensure equipment is available and maintained.
  • 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 is stable and within specifications.
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7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: Ensure all certificates are current and valid.
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of calibration points will be five, including endpoints and midpoints. Each point will have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the sensor to stabilize as per manufacturer instructions.
  3. As Found checks and data capture: Record initial readings before any adjustments.
  4. Adjustment rules: If OOT is found, adjustments may be made if permitted; otherwise, escalate to QA.
  5. As Left verification: Confirm that the sensor is within tolerance after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±2% from the true value. The error calculation formula is:

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

Pass/Fail logic: If the error is within ±2%, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and initiate deviation process.
  • Impact assessment trigger: Define 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: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records as per 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-0098 Dissolved Oxygen Sensor (Bioreactor) DO Sensor Biologics Bioreactor DO control Dissolved Oxygen %DO 0 – 200 ±2% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 %DO
  • 25% of Range: 50 %DO
  • 50% of Range: 100 %DO
  • 75% of Range: 150 %DO
  • Maximum: 200 %DO

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 %DO [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
50 %DO [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
100 %DO [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
150 %DO [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
200 %DO [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Dissolved Oxygen Sensor is clean and calibrated according to the manufacturer’s specifications.
  2. Stabilization: Allow the sensor to stabilize in the calibration environment for at least [TBD] minutes.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±2%.
  6. Documentation: Record all observations, errors, and pass/fail results in the results table.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine the impacted results window: [TBD].
  • Await QA decision before proceeding.

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-0098 Dissolved Oxygen Sensor (Bioreactor) Biologics Bioreactor Dissolved Oxygen 0 – 200 %DO ±2% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow sensor to warm up for the recommended time
  • [ ] Clean the sensor as per SOP
  • [ ] Level the sensor if applicable
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation
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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
  • [ ] Stop use of the sensor
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all results are within acceptance 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
Asset: Dissolved Oxygen Sensor (Bioreactor)
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/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-0098 Dissolved Oxygen Sensor (Bioreactor) DO Sensor Biologics Bioreactor [TBD] [TBD] [TBD] Dissolved Oxygen / 0-200 %DO ±2%

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] Traceability: ISO17025

Results

As Found Results

Test Point Measured Value (%DO) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (%DO) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [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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