Calibration Documents: CO2 Incubator Temp Sensor (CAL-0306)

Asset ID	CAL-0306
Equipment	CO2 Incubator Temp Sensor
Equipment Type	Temperature Sensor
Department	Biologics
Area/Location	Cell Culture
Process Use	Temperature
Parameter	Temperature
Units	°C
Range Min	20
Range Max	45
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 CO2 Incubator Temperature Sensor is performed to ensure accurate temperature readings within the specified range, which is critical for maintaining optimal conditions in cell culture processes. This calibration controls risks related to patient safety, batch quality, and data integrity by ensuring that the temperature measurements are reliable and consistent.

2. Scope

• Asset ID: CAL-0306
• Equipment Name/Type: CO2 Incubator Temp Sensor / Temperature Sensor
• Department/Area: Biologics / Cell Culture
• Process Use: Temperature
• Parameter: Temperature
• Range: 20°C to 45°C
• Units: °C
• Calibration Frequency: Every 180 days

3. Definitions

• Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
• Verification: The process of confirming that a measurement instrument is functioning correctly.
• Adjustment: The act of modifying a measurement instrument to bring it into alignment with a standard.
• 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 deviation of a measurement instrument from its true value 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 of a measurement lies.
• Intermediate Check: A verification process conducted between calibrations to ensure ongoing 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 ensure compliance.
• Owner Department: Ensure equipment is available and maintained.
• 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 as per manufacturer’s recommendations.
• Maintain cleanliness of the equipment and surrounding area.
• Verify that the equipment is level and stable.
• Check power supply and connections prior to calibration.

7. Standards & Tools

• Reference Standards: [TBD]
• Traceability Statement: ISO17025
• Certificate Validity Check: Ensure all calibration certificates are current and valid.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints (20°C and 45°C) and midpoints.
• 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 temperature sensor to stabilize within the operational range.
3. As Found checks and data capture: Record initial 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 readings are 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 (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use until resolved.
• Notification & deviation initiation: Notify QA and initiate a deviation report.
• Impact assessment trigger: Define impact window and review affected results/batches.
• Recalibration after repair/adjustment: Perform recalibration post-adjustment.
• 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

• Equipment clean and operational
• Environmental conditions verified
• Calibration standards available
• 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-0306	CO2 Incubator Temp Sensor	Temperature Sensor	Biologics	Cell Culture	Temperature	Temperature	°C	20 – 45	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 20°C
• 25%: 26.25°C
• 50%: 32.5°C
• 75%: 38.75°C
• Maximum: 45°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
20°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
26.25°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
32.5°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
38.75°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
45°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the CO2 incubator is operational and at the desired temperature range.
2. Stabilization: Allow the incubator to stabilize for a minimum of [TBD] hours before calibration.
3. Performing Readings: Take at least three replicate readings at each test point.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated errors to the acceptance criteria of ±0.5°C.
6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the supervisor and quality assurance.
• 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-0306	CO2 Incubator Temp Sensor	Biologics	Cell Culture	Temperature	20 – 45 °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 calibration logbook is ready for documentation

As Found Execution

• [ ] Set temperature setpoints as per calibration protocol
• [ ] 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 (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 confirm accuracy
• [ ] Ensure all measurements are within acceptance limits

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate, with complete traceability.

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Deviation Impact Assessment

Event Summary
Asset: CO2 Incubator Temp Sensor Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the affected equipment
• Label/tag the equipment 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-0306	CO2 Incubator Temp Sensor	Temperature Sensor	Biologics	Cell Culture	[TBD]	[TBD]	[TBD]	Temperature: 20 – 45 °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)	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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