Calibration Documents: Bioreactor DO Probe (CAL-0302)

Asset ID	CAL-0302
Equipment	Bioreactor DO Probe
Equipment Type	DO Probe
Department	Biologics
Area/Location	Bioreactor
Process Use	DO control
Parameter	DO
Units	%DO
Range Min	0
Range Max	200
Acceptance Criteria	±2%
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Bioreactor DO Probe is performed to ensure accurate dissolved oxygen (DO) measurements, which are critical for maintaining optimal conditions in biologics production. Accurate calibration mitigates risks related to patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

• Asset ID: CAL-0302
• Equipment Name/Type: Bioreactor DO Probe
• Department/Area: Biologics
• Process Use: DO control
• Parameter: DO
• Range: 0% DO to 200% DO
• Units: %DO
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
• Verification: The process of confirming that an instrument is functioning correctly.
• Adjustment: The act of altering the instrument to bring it into compliance with 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 exceeds the 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 associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement.
• Intermediate Check: A periodic verification of an instrument’s performance 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 for compliance.
• Owner Department: Ensure equipment is available and properly maintained.
• External Service Provider: Conduct external calibration as per the defined schedule.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment warm-up/stabilization time as per manufacturer guidelines.
• Maintain cleanliness of the equipment and surrounding area.
• Check leveling of the equipment.
• Verify power supply stability and functionality.

7. Standards & Tools

• Reference Standards: [TBD]
• Traceability Statement: ISO17025
• Certificate Validity Check: Ensure all 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 and midpoints across the range of 0% DO to 200% DO.
• Replicate readings: 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the Bioreactor DO Probe to stabilize before taking measurements.
3. As Found checks and data capture: Record initial readings and document them contemporaneously (ALCOA+).
4. Adjustment rules: If OOT is found, follow the adjustment protocol; otherwise, escalate the issue.
5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Bioreactor DO Probe is ±2%. The error calculation formula is:

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

Pass/Fail Logic: If the error is within ±2%, the calibration is considered a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag the equipment and stop its 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: Ensure recalibration is performed post-adjustment.
• 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 warm-up completed
• Cleanliness checked
• Leveling confirmed
• Power supply verified

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-0302	Bioreactor DO Probe	DO Probe	Biologics	Bioreactor	DO control	DO	%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%: 50 %DO
• 50%: 100 %DO
• 75%: 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 Bioreactor DO Probe is clean and free from contaminants.
2. Stabilization: Allow the probe to stabilize in the calibration environment 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 test point using the formula: Error = Observed – Ref Value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±2%.
6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

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

• Stop use of the Bioreactor DO Probe immediately.
• Notify the QA department.
• 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-0302	Bioreactor DO Probe	Biologics	Bioreactor	DO	0 – 200 %DO	±2%	180 days	ISO17025

Pre-calibration

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

As Found Execution

• [ ] Set the probe to specified setpoints
• [ ] Perform repeat measurements
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations

OOT Immediate Actions

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

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm all 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, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Bioreactor DO 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: [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-0302	Bioreactor DO Probe	DO Probe	Biologics	Bioreactor	[TBD]	[TBD]	[TBD]	DO: 0 – 200 %DO	±2%

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 (%DO)	Acceptance Criteria	Pass/Fail
1	[TBD]	±2%	[TBD]
2	[TBD]	±2%	[TBD]
3	[TBD]	±2%	[TBD]
4	[TBD]	±2%	[TBD]
5	[TBD]	±2%	[TBD]

As Left Results

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