Calibration Documents: Inline Temp Sensor (Reactor Jacket) (CAL-0200)

Asset ID	CAL-0200
Equipment	Inline Temp Sensor (Reactor Jacket)
Equipment Type	Temperature Sensor
Department	API
Area/Location	Process Area
Process Use	Reaction control
Parameter	Temperature
Units	°C
Range Min	-20
Range Max	200
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Inline Temp Sensor (Reactor Jacket) is performed to ensure accurate temperature measurements critical for reaction control in the API process area. This calibration mitigates risks associated with inaccurate temperature readings that could compromise patient safety, batch quality, and data integrity.

2. Scope

• Asset ID: CAL-0200
• Equipment Name/Type: Inline Temp Sensor (Reactor Jacket) / Temperature Sensor
• Department/Area: API / Process Area
• Process Use: Reaction control
• Parameter: Temperature
• Range: -20°C to 200°C
• Units: °C
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
• Verification: The confirmation that a measurement instrument meets specified requirements.
• Adjustment: The process of modifying a measurement 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 results fall outside the defined acceptance criteria.
• Drift: The gradual change in a measurement instrument’s performance 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 verification of an instrument’s performance between scheduled 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 and results.
• Owner Department: Ensure equipment is available and in proper condition for calibration.
• External Service Provider: Conduct calibration as per external calibration type.

6. Safety & Preconditions

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

7. Standards & Tools

• Reference Standards: [TBD]
• Traceability Statement: ISO17025
• Certificate Validity Check: Ensure all reference standards are within their validity period.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

• Minimum number of points: 5 points including endpoints (-20°C, 0°C, 100°C, 200°C).
• 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 Inline Temp Sensor to stabilize at the operating conditions.
3. As Found checks and data capture: Record initial temperature readings at defined points.
4. Adjustment rules: If OOT is detected, follow escalation procedures for adjustment.
5. As Left verification: Record final readings after adjustments.
6. Labeling + documentation completion: Ensure all calibration records are completed and labeled.

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 |Error| ≤ 0.5°C, then Pass; otherwise, Fail.

Rounding Rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use.
• Notification & deviation initiation: Notify QA and initiate deviation process.
• Impact assessment trigger: Define impact window and review of affected results/batches.
• Recalibration after repair/adjustment: Schedule recalibration post-adjustment.
• QA disposition: [TBD]

12. Records & Retention

• Logbook entries: Document all calibration activities.
• Calibration report/certificate filing: Maintain records as per 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 confirmed
• Leveling checked
• 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-0200	Inline Temp Sensor (Reactor Jacket)	Temperature Sensor	API	Process Area	Reaction control	Temperature	°C	-20 to 200	±0.5°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: -20 °C
• 25% of Range: 45 °C
• 50% of Range: 90 °C
• 75% of Range: 155 °C
• Maximum: 200 °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]
45 °C	[TBD]	[TBD]	[TBD]	±0.5 °C	[TBD]	[TBD]	[TBD]	[TBD]
90 °C	[TBD]	[TBD]	[TBD]	±0.5 °C	[TBD]	[TBD]	[TBD]	[TBD]
155 °C	[TBD]	[TBD]	[TBD]	±0.5 °C	[TBD]	[TBD]	[TBD]	[TBD]
200 °C	[TBD]	[TBD]	[TBD]	±0.5 °C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the calibration equipment is clean and functional. Verify that the Inline Temp Sensor is properly installed and operational.
2. Stabilization: Allow the sensor to stabilize at room temperature for at least 30 minutes before calibration.
3. Performing Readings:
   • Record the temperature at each test point (min, 25%, 50%, 75%, max).
   • Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed Value – Reference Value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.5 °C.
6. Documentation: Complete the results table with all observed values, errors, and pass/fail status.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

• Stop use of the Inline Temp Sensor 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-0200	Inline Temp Sensor (Reactor Jacket)	API	Process Area	Temperature	-20 to 200 °C	±0.5°C	365 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
• [ ] Ensure equipment is level
• [ ] Confirm reference standards are valid and calibrated
• [ ] Logbook is ready for documentation

As Found Execution

• [ ] Set temperature setpoints as per calibration protocol
• [ ] 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
• [ ] Stop use of the equipment immediately
• [ ] Notify the QA department
• [ ] Document deviation in the logbook
• [ ] Trigger impact review as per SOP

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm all readings are within acceptance limits

Documentation & Closure

• [ ] Update equipment label with calibration details
• [ ] Attach calibration certificate to logbook
• [ ] Obtain reviewer sign-off
• [ ] 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: Inline Temp Sensor (Reactor Jacket) Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the affected 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-0200	Inline Temp Sensor (Reactor Jacket)	Temperature Sensor	API	Process Area	[TBD]	[TBD]	[TBD]	Temperature: -20 to 200 °C	±0.5°C

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID	Certificate No	Due Date	Traceability Statement
[TBD]	[TBD]	[TBD]	Traceability: ISO17025

Results

As Found Results

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

As Left Results

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