Calibration Documents: Autoclave Temp Sensor (CAL-0150)

Asset ID	CAL-0150
Equipment	Autoclave Temp Sensor
Equipment Type	Temperature Sensor
Department	Microbiology
Area/Location	Sterilization
Process Use	Sterilization
Parameter	Temperature
Units	°C
Range Min	100
Range Max	140
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 Autoclave Temp Sensor is performed to ensure accurate temperature readings during the sterilization process. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate temperature measurement is essential to prevent under- or over-sterilization, which could compromise product safety and efficacy.

2. Scope

• Asset ID: CAL-0150
• Equipment Name/Type: Autoclave Temp Sensor / Temperature Sensor
• Department/Area: Microbiology / Sterilization
• Process Use: Sterilization
• Parameter: Temperature
• Range: 100°C to 140°C
• Units: °C
• Calibration Frequency: 180 days

3. Definitions

• Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
• Verification: The process of confirming that a measurement instrument is functioning correctly.
• Adjustment: The process of modifying a measurement instrument to bring it into compliance with standards.
• As Found: The condition of the measurement instrument prior to any adjustments.
• As Left: The condition of the measurement instrument after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement falls outside the established acceptance criteria.
• Drift: The gradual change in a measurement instrument’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 a measurement instrument 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 results and ensure 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’s guidelines.
• Maintain cleanliness of the calibration area.
• Check that the equipment is level and stable.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of calibration points will be five, including endpoints and midpoints of the specified range (100°C to 140°C). It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and documentation.
2. Stabilization: Allow the sensor to reach operating conditions.
3. As Found checks and data capture: Record initial readings at specified points.
4. Adjustment rules: If OOT is found, escalate to QA for further action.
5. As Left verification: Confirm that adjustments bring the sensor within acceptance criteria.
6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is less than or equal to 0.5°C, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use.
• Notification & deviation initiation: Notify QA and document the deviation.
• Impact assessment trigger: Review affected results/batches within the impact window.
• Recalibration after repair/adjustment: Ensure recalibration is performed before reuse.
• QA disposition: [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: Calibrated date, due date, technician name, 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 area cleanliness confirmed
• Power supply checked

Annexure C: Example Label Text

Calibrated 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-0150	Autoclave Temp Sensor	Temperature Sensor	Microbiology	Sterilization	Sterilization	Temperature	°C	100 – 140	±0.5°C	180 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 100°C
• 25% of Range: 110°C
• 50% of Range: 120°C
• 75% of Range: 130°C
• Maximum: 140°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
100°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
110°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
120°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
130°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
140°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the autoclave temperature sensor is clean and properly installed.
2. Stabilization: Allow the sensor to stabilize at room temperature for [TBD] minutes before calibration.
3. Performing Readings:
   • Take three replicate readings at each test point.
   • Record the observed values in the results table.
4. Calculating Error: Calculate the error for each observed value using the formula: Error = Observed – Ref Value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.5°C.
6. Documentation: Complete the results table and ensure all data is recorded accurately (ALCOA+).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the supervisor and quality assurance (QA) personnel.
• 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-0150	Autoclave Temp Sensor	Microbiology	Sterilization	Temperature	100 – 140 °C	±0.5°C	180 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Ensure temperature sensor has warmed up adequately
• [ ] Clean the equipment as per SOP
• [ ] Level the equipment if necessary
• [ ] Check validity of reference standards
• [ ] Ensure calibration logbook is ready for entries

As Found Execution

• [ ] Set the temperature sensor 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
• [ ] Stop use of the equipment immediately
• [ ] Notify QA and relevant personnel
• [ ] Document deviation and OOT findings
• [ ] Trigger impact review as per SOP

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 records
• [ ] Update next due date in the 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: Autoclave Temp Sensor 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-0150	Autoclave Temp Sensor	Temperature Sensor	Microbiology	Sterilization	[TBD]	[TBD]	[TBD]	Temperature: 100 – 140 °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)	Comments
100	[TBD]	[TBD]
110	[TBD]	[TBD]
120	[TBD]	[TBD]
130	[TBD]	[TBD]
140	[TBD]	[TBD]

As Left Results

Test Point	Measured Value (°C)	Comments
100	[TBD]	[TBD]
110	[TBD]	[TBD]
120	[TBD]	[TBD]
130	[TBD]	[TBD]
140	[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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