Bioreactor pH Probe (CAL-0301) – Calibration Documents

Calibration Documents: Bioreactor pH Probe (CAL-0301)

Asset ID CAL-0301
Equipment Bioreactor pH Probe
Equipment Type pH Probe
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 Bioreactor pH Probe is performed to ensure accurate pH control during biologics production processes. This calibration is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Inaccurate pH measurements can lead to suboptimal conditions for biological processes, potentially impacting product efficacy and safety.

2. Scope

  • Asset ID: CAL-0301
  • Equipment Name/Type: Bioreactor pH Probe
  • Department/Area: Biologics
  • 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 an instrument against a known standard.
  • Verification: The confirmation that an instrument meets specified requirements.
  • Adjustment: The process of modifying an 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 instrument’s measurements fall outside the specified acceptance criteria.
  • Drift: The gradual change in an 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 periodic 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 record data.
  • QC/QA Reviewer: Review calibration data and documentation.
  • 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 pH probe as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply stability.
See also  Pycnometer (Density bottle) (CAL-0046) - Calibration Documents

7. Standards & Tools

  • Reference Standards: Calibration standards compliant with ISO17025.
  • Traceability Statement: Calibration will be traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow an As Found then As Left logic. The minimum number of calibration points will be five, including endpoints and midpoints of the specified range (1 to 14 pH). Each point will have three replicate readings recorded as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the pH probe to stabilize as per manufacturer instructions.
  3. As Found checks and data capture: Measure pH at defined points and record data contemporaneously (ALCOA+).
  4. Adjustment rules: If any readings are OOT, adjust the probe if permitted; otherwise, escalate the issue.
  5. As Left verification: Re-measure pH after adjustments and record results.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Bioreactor pH Probe is ±0.05 pH. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration after any necessary repairs.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records of calibration certificates.
  • 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-0301 Bioreactor pH Probe pH Probe Biologics Bioreactor pH control pH pH 1 – 14 ±0.05 180 days External ISO17025
See also  Chromatography Skid Flow Meter (CAL-0311) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

  • Minimum: 1
  • 25% of Range: 4
  • 50% of Range: 7.5
  • 75% of Range: 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 Bioreactor pH Probe is clean and properly connected to the calibration equipment.
  2. Stabilization: Allow the probe to stabilize in the calibration solution for at least 30 minutes.
  3. Performing Readings: Take three replicate readings at each test point and record the values.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±0.05.
  6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the Bioreactor pH Probe immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • 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-0301 Bioreactor pH Probe Biologics Bioreactor pH 1 – 14 ±0.05 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the pH probe according to cleaning procedure
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the pH probe to specified setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  BOD Incubator Temp Sensor (CAL-0157) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the supervisor and QA
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

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

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: Bioreactor pH Probe
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-0301 Bioreactor pH Probe pH Probe 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] ISO17025

Results

As Found Results

Test Point Measured Value 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 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: [TBD]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: __________

Checked by: ______________________ Date: __________

Approved by: ______________________ Date: __________

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