Calibration Documents: Depyrogenation Tunnel Temp Sensor (CAL-0222)

Asset ID	CAL-0222
Equipment	Depyrogenation Tunnel Temp Sensor
Equipment Type	Temperature Sensor
Department	Sterile
Area/Location	Depyrogenation
Process Use	Depyrogenation
Parameter	Temperature
Units	°C
Range Min	150
Range Max	350
Acceptance Criteria	±2°C
Calibration Frequency (days)	180
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Depyrogenation Tunnel Temperature Sensor is performed to ensure accurate temperature measurements within the critical range of 150°C to 350°C. This calibration controls risks associated with patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

• Asset ID: CAL-0222
• Equipment Name/Type: Depyrogenation Tunnel Temp Sensor / Temperature Sensor
• Department/Area: Sterile / Depyrogenation
• Process Use: Depyrogenation
• Parameter: Temperature
• Range: 150°C to 350°C
• Units: °C
• Calibration Frequency: Every 180 days

3. Definitions

• Calibration: The process of comparing a measurement device to a known standard to determine its accuracy.
• Verification: The process of confirming that a measurement device is functioning correctly.
• Adjustment: The process of modifying a measurement device to bring it within specified limits.
• 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 the 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 dispersion of the values attributed to a measured quantity.
• Intermediate Check: A quick verification of the measurement device’s performance between full 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 in good condition 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 as per manufacturer’s recommendations.
• Maintain cleanliness of the equipment and surrounding area.
• Check that the equipment is level and stable.
• Verify power supply is stable and within specifications.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of calibration points will be five, including endpoints (150°C and 350°C) and midpoints (200°C, 250°C, and 300°C). Each point will have three replicate readings taken as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and documentation.
2. Stabilization: Allow the temperature sensor to stabilize at the operating conditions.
3. As Found checks and data capture: Record the temperature readings at the defined points.
4. Adjustment rules: If any readings are OOT, follow the adjustment protocol; if not allowed, escalate to QA.
5. As Left verification: Recheck the sensor after adjustments to ensure it meets specifications.
6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the temperature sensor is ±2°C. 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: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag the equipment and cease use.
• Notification & deviation initiation: Notify QA and initiate a deviation report.
• Impact assessment trigger: Define the impact window and review affected results/batches.
• Recalibration after repair/adjustment: Schedule recalibration as necessary.
• QA disposition: [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 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-0222	Depyrogenation Tunnel Temp Sensor	Temperature Sensor	Sterile	Depyrogenation	Depyrogenation	Temperature	°C	150 – 350	±2°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 specified range of 150°C to 350°C:

• Min: 150°C
• 25%: 200°C
• 50%: 250°C
• 75%: 300°C
• Max: 350°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
150°C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
200°C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
250°C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
300°C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]
350°C	[TBD]	[TBD]	[TBD]	±2°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the calibration equipment is clean and in good working condition.
2. Stabilization: Allow the temperature sensor to stabilize at room temperature for at least 30 minutes.
3. Performing Readings:
   • Set the temperature sensor to each test point.
   • Allow sufficient time for the sensor to reach the test point temperature.
   • Take three replicate readings at each test point.
4. Calculating Error: Calculate the error for each test point by subtracting the reference value from the observed value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±2°C.
6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the temperature sensor.
• Notify the QA department immediately.
• Open a deviation report.
• Quarantine the 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-0222	Depyrogenation Tunnel Temp Sensor	Sterile	Depyrogenation	Temperature	150 – 350 °C	±2°C	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Allow equipment to warm up as per SOP
• [ ] Clean the sensor and surrounding area
• [ ] Level the equipment if necessary
• [ ] Confirm reference standards are valid and calibrated
• [ ] Ensure logbook is ready for data entry

As Found Execution

• [ ] Set temperature setpoints according to SOP
• [ ] Perform multiple repeats for accuracy
• [ ] Record raw data in logbook
• [ ] 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 appropriate personnel
• [ ] Document deviation in logbook
• [ ] Trigger impact review process

As Left Verification

• [ ] Conduct post-adjustment checks to confirm accuracy
• [ ] Ensure 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 results
• [ ] 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: Depyrogenation Tunnel Temp Sensor Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the equipment
• Label/tag the equipment 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-0222	Depyrogenation Tunnel Temp Sensor	Temperature Sensor	Sterile	Depyrogenation	[TBD]	[TBD]	[TBD]	Temperature: 150 – 350 °C	±2°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)	Remarks
1	[TBD]	[TBD]
2	[TBD]	[TBD]
3	[TBD]	[TBD]
4	[TBD]	[TBD]
5	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (°C)	Remarks
1	[TBD]	[TBD]
2	[TBD]	[TBD]
3	[TBD]	[TBD]
4	[TBD]	[TBD]
5	[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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