Calibration Documents: Bioreactor Temperature Probe (CAL-0300)

Asset ID	CAL-0300
Equipment	Bioreactor Temperature Probe
Equipment Type	Temperature Probe
Department	Biologics
Area/Location	Bioreactor
Process Use	Temp control
Parameter	Temperature
Units	°C
Range Min	0
Range Max	60
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Bioreactor Temperature Probe is performed to ensure accurate temperature control within the bioreactor. This calibration is critical for maintaining product quality, ensuring patient safety, and preserving data integrity during biologics manufacturing processes. Accurate temperature measurements are essential to prevent deviations that could affect batch quality and compliance with regulatory standards.

2. Scope

• Asset ID: CAL-0300
• Equipment Name/Type: Bioreactor Temperature Probe / Temperature Probe
• Department/Area: Biologics / Bioreactor
• Process Use: Temperature control
• Parameter: Temperature
• Range: 0°C to 60°C
• Units: °C
• 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 meets specified requirements.
• 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 does not meet specified acceptance criteria.
• Drift: The gradual change in a measurement device’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 expected 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 document results.
• QC/QA Reviewer: Review calibration documentation for compliance.
• 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 equipment to warm up and stabilize as per manufacturer guidelines.
• Maintain cleanliness of the calibration area and equipment.
• Check leveling of the equipment prior to calibration.
• Verify power supply stability and functionality.

7. Standards & Tools

• Reference Standards: [TBD]
• Traceability Statement: Calibration traceable to ISO17025.
• Certificate Validity Check: Ensure all calibration certificates are current.
• Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints (0°C, 60°C) and midpoints (30°C).
• Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and standards.
2. Stabilization: Allow the temperature probe to stabilize at the calibration environment.
3. As Found checks and data capture: Record initial temperature readings at specified points.
4. Adjustment rules: If OOT is found, follow escalation procedures; adjustments are only permitted if allowed.
5. As Left verification: Confirm that the probe is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record all raw observations contemporaneously to ensure ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C.

Error calculation formula: Error = Observed Value – True Value.

Pass/Fail Logic: If the absolute value of Error is within acceptance criteria, mark as Pass; otherwise, mark as Fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use until resolved.
• 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 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
• Calibration tools prepared
• Documentation ready

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-0300	Bioreactor Temperature Probe	Temperature Probe	Biologics	Bioreactor	Temp control	Temperature	°C	0 – 60	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 0°C
• 25% of Range: 15°C
• 50% of Range: 30°C
• 75% of Range: 45°C
• Maximum: 60°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
0°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
15°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
30°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
45°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
60°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the bioreactor temperature probe is clean and properly connected.
2. Stabilization: Allow the probe to stabilize at room temperature for at least 30 minutes.
3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error as the difference between the observed value and the reference value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.5°C.
6. Documentation: Record all observations, errors, and results in the results table.

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

• Stop use of the equipment 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-0300	Bioreactor Temperature Probe	Biologics	Bioreactor	Temperature	0 to 60 °C	±0.5°C	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per SOP
• [ ] Clean the equipment as per cleaning procedure
• [ ] Level the equipment if necessary
• [ ] Check validity of reference standards
• [ ] Ensure logbook is ready for documentation

As Found Execution

• [ ] Set the temperature probe to specified setpoints
• [ ] Perform repeat measurements as required
• [ ] Record raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance
• [ ] Stop use of the equipment immediately
• [ ] Notify relevant personnel of the OOT condition
• [ ] Document deviation in the logbook
• [ ] Trigger impact review as per SOP

As Left Verification

• [ ] Perform post-adjustment checks to confirm accuracy
• [ ] Ensure all measurements are within acceptance limits

Documentation & Closure

• [ ] Update equipment label with calibration details
• [ ] Attach calibration certificate to logbook
• [ ] Obtain reviewer sign-off on calibration record
• [ ] 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 Temperature 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-0300	Bioreactor Temperature Probe	Temperature Probe	Biologics	Bioreactor	[TBD]	[TBD]	[TBD]	Temperature: 0 – 60 °C	±0.5°C

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 (°C)	Pass/Fail
0	[TBD]	[TBD]
15	[TBD]	[TBD]
30	[TBD]	[TBD]
45	[TBD]	[TBD]
60	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (°C)	Pass/Fail
0	[TBD]	[TBD]
15	[TBD]	[TBD]
30	[TBD]	[TBD]
45	[TBD]	[TBD]
60	[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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