Calibration Documents: Fermenter Temperature Probe (CAL-0304)

Asset ID	CAL-0304
Equipment	Fermenter Temperature Probe
Equipment Type	Temperature Probe
Department	Biologics
Area/Location	Fermentation
Process Use	Temp control
Parameter	Temperature
Units	°C
Range Min	0
Range Max	80
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 Fermenter Temperature Probe is performed to ensure accurate temperature control during the fermentation process. This calibration is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate temperature readings are essential to prevent deviations that could compromise product quality and safety.

2. Scope

• Asset ID: CAL-0304
• Equipment Name/Type: Fermenter Temperature Probe / Temperature Probe
• Department/Area: Biologics / Fermentation
• Process Use: Temperature control
• Parameter: Temperature
• Range: 0°C to 80°C
• Units: °C
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of comparing a measurement device to a known standard to ensure accuracy.
• Verification: The process of confirming that a measurement device is functioning correctly.
• Adjustment: The process of modifying a measurement device to bring it into compliance with standards.
• As Found: The condition of the equipment prior to any adjustments being made.
• As Left: The condition of the equipment after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement falls outside the defined 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 asserted to lie.
• Intermediate Check: A periodic check of the measurement device to ensure it remains within specified limits.

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 accessible for calibration.
• External Service Provider: Conduct external calibration as per schedule.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm up and stabilize before calibration.
• Maintain cleanliness of the equipment and surrounding area.
• Check that the equipment is level and properly positioned.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference Standards Required: [TBD]
• Traceability Statement: ISO17025
• Certificate Validity Check: Ensure all certificates are current and valid.
• 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, 80°C) and midpoints (40°C).
• 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 temperature probe to stabilize at the calibration environment.
3. As Found checks and data capture: Record initial temperature 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 probe is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Ensure all calibration records are completed and labeled.

Record 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 cease 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 for audit purposes.
• 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 stable

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-0304	Fermenter Temperature Probe	Temperature Probe	Biologics	Fermentation	Temp control	Temperature	°C	0 – 80	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

• Min: 0°C
• 25%: 20°C
• 50%: 40°C
• 75%: 60°C
• Max: 80°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]
20°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
40°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
60°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
80°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the temperature probe is clean and calibrated prior to use.
2. Stabilization: Allow the probe to stabilize at room temperature for at least 30 minutes.
3. Performing Readings:
   • Immerse the probe in the first test point.
   • Wait for a stable reading (at least 1 minute).
   • Record the observed value.
   • Repeat for each test point, ensuring to take at least three replicates for each.
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.
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 equipment.
• Notify the supervisor immediately.
• Open a deviation report.
• Quarantine impacted results window: [TBD]
• Await QA decision on further actions.

Approvals

Prepared By	Reviewed By	Approved By
[Signature/Date]	[Signature/Date]	[Signature/Date]

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0304	Fermenter Temperature Probe	Biologics	Fermentation	Temperature	0 to 80 °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 temperature probe as per cleaning procedure
• [ ] Ensure the probe is leveled correctly
• [ ] Check validity of reference standards
• [ ] Ensure calibration logbook is ready for entries

As Found Execution

• [ ] Set the temperature probe to specified setpoints
• [ ] Perform multiple repeats for accuracy
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

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

As Left Verification

• [ ] Conduct 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 documentation
• [ ] Update next due date for calibration

Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Fermenter 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 tolerance
• 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-0304	Fermenter Temperature Probe	Temperature Probe	Biologics	Fermentation	[TBD]	[TBD]	[TBD]	Temperature (0-80) °C	±0.5°C

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 (°C)	Acceptance Criteria	Pass/Fail
1	[TBD]	±0.5°C	[TBD]
2	[TBD]	±0.5°C	[TBD]
3	[TBD]	±0.5°C	[TBD]
4	[TBD]	±0.5°C	[TBD]
5	[TBD]	±0.5°C	[TBD]

As Left Results

Test Point	Measured Value (°C)	Acceptance Criteria	Pass/Fail
1	[TBD]	±0.5°C	[TBD]
2	[TBD]	±0.5°C	[TBD]
3	[TBD]	±0.5°C	[TBD]
4	[TBD]	±0.5°C	[TBD]
5	[TBD]	±0.5°C	[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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