Inline pH Sensor (Bioreactor) (CAL-0092) – Calibration Documents

Calibration Documents: Inline pH Sensor (Bioreactor) (CAL-0092)

Asset ID CAL-0092
Equipment Inline pH Sensor (Bioreactor)
Equipment Type Inline pH Sensor
Department Biologics
Area/Location Bioreactor
Process Use pH control
Parameter pH
Units pH
Range Min 1
Range Max 14
Acceptance Criteria ±0.05
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 pH Sensor (Bioreactor) is performed to ensure accurate pH control within the bioreactor process. This calibration is critical for maintaining batch quality, ensuring patient safety, and preserving data integrity. Accurate pH measurements are essential to prevent deviations that could compromise product quality and safety.

2. Scope

  • Asset ID: CAL-0092
  • Equipment Name/Type: Inline pH Sensor (Bioreactor)
  • Department/Area: Biologics/Bioreactor
  • Process Use: pH control
  • Parameter: pH
  • Range: 1 to 14
  • Units: pH
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The confirmation that a measurement instrument is functioning within specified limits.
  • Adjustment: The process of modifying a measurement instrument to bring it within specified limits.
  • As Found: The condition of the instrument prior to calibration.
  • As Left: The condition of the instrument after calibration.
  • OOT (Out of Tolerance): A condition where the measurement results fall outside the specified acceptance criteria.
  • Drift: The gradual change in the output of a measurement instrument over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A verification process conducted between scheduled 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results for compliance.
  • Owner Department: Ensure equipment is available and properly maintained.
  • External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer specifications.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
See also  Balance Calibration Weight 100 g (CAL-0336) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within their validity period.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (1, 14) and midpoints (7).
  • 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 Inline pH Sensor to stabilize as per manufacturer guidelines.
  3. As Found checks and data capture: Record initial pH readings at defined points.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Confirm that the sensor is within acceptance criteria after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

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

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.05 pH

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of Error is less than or equal to ±0.05, then Pass; otherwise, Fail.

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 of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-repair.
  • 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, by whom, 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 stabilized
  • Calibration data recorded
  • Documentation completed

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

See also  Differential Pressure Gauge 0-250 Pa (CAL-0076) - 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-0092 Inline pH Sensor (Bioreactor) Inline pH Sensor Biologics Bioreactor pH control pH pH 1 – 14 ±0.05 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 1
  • 25%: 4
  • 50%: 7.5
  • 75%: 11
  • Maximum: 14

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
1 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
4 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
7.5 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
11 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
14 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Inline pH Sensor is clean and properly installed in the bioreactor.
  2. Stabilization: Allow the sensor to stabilize for [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.
  5. Evaluation: Compare the error against the acceptance criteria of ±0.05.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

In the event of an Out of Tolerance (OOT) condition:

  • Stop use of the Inline pH 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-0092 Inline pH Sensor (Bioreactor) Biologics Bioreactor pH 1 – 14 ±0.05 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow sensor to warm up as per manufacturer guidelines
  • [ ] Clean the sensor according to SOP
  • [ ] Ensure sensor is level
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Record initial setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record all raw data
  • [ ] Perform necessary calculations
See also  Pressure Gauge 0-10 bar (CAL-0071) - 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

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all readings are within acceptance limits

Documentation & Closure

  • [ ] Update calibration 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, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Inline pH 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 service
  • 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-0092 Inline pH Sensor (Bioreactor) Inline pH Sensor Biologics Bioreactor [TBD] [TBD] [TBD] pH (1 – 14) ±0.05

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (pH) Acceptance Criteria Pass/Fail
1 [TBD] ±0.05 [TBD]
2 [TBD] ±0.05 [TBD]
3 [TBD] ±0.05 [TBD]
4 [TBD] ±0.05 [TBD]
5 [TBD] ±0.05 [TBD]

As Left Results

Test Point Measured Value (pH) Acceptance Criteria Pass/Fail
1 [TBD] ±0.05 [TBD]
2 [TBD] ±0.05 [TBD]
3 [TBD] ±0.05 [TBD]
4 [TBD] ±0.05 [TBD]
5 [TBD] ±0.05 [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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