Heating Mantle Controller Temp (CAL-0159) – Calibration Documents

Calibration Documents: Heating Mantle Controller Temp (CAL-0159)

Asset ID CAL-0159
Equipment Heating Mantle Controller Temp
Equipment Type Heating Mantle
Department QC
Area/Location Chemistry Lab
Process Use Heating
Parameter Temperature
Units °C
Range Min 20
Range Max 300
Acceptance Criteria ±2°C
Calibration Frequency (days) 365
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Heating Mantle Controller Temp is performed to ensure accurate temperature readings during the heating process in the Chemistry Lab. This calibration controls the risk of inaccurate temperature settings, which can affect batch quality and data integrity, ultimately impacting product safety and compliance.

2. Scope

  • Asset ID: CAL-0159
  • Equipment Name/Type: Heating Mantle Controller Temp / Heating Mantle
  • Department/Area: QC / Chemistry Lab
  • Process Use: Heating
  • Parameter: Temperature
  • Range: 20°C to 300°C
  • Units: °C
  • Calibration Frequency: 365 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 operates within specified limits.
  • Adjustment: The act of modifying a measurement instrument to bring it into compliance with standards.
  • As Found: The condition of the instrument prior to any adjustments made during calibration.
  • As Left: The condition of the instrument after adjustments have been made and verified.
  • OOT (Out of Tolerance): A condition where the measurement falls 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 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 records and ensure compliance.
  • Owner Department: Ensure equipment is available and properly 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 before calibration.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within specifications.
See also  Turbidity Meter (CAL-0232) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the range of 20°C to 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 standards.
  2. Stabilization: Allow the Heating Mantle to reach operating temperature.
  3. As Found checks and data capture: Measure temperature at defined points and record results contemporaneously.
  4. Adjustment rules: If any readings are OOT, escalate for adjustment as per SOP.
  5. As Left verification: Confirm that all adjustments bring the instrument within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±2°C from the target temperature. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within ±2°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 initiate deviation process.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Maintain detailed records of calibration activities.
  • Calibration report/certificate filing: Store all calibration certificates securely.
  • 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-0159 Heating Mantle Controller Temp Heating Mantle QC Chemistry Lab Heating Temperature °C 20 – 300 ±2°C 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 20°C
  • 25%: 85°C
  • 50%: 160°C
  • 75%: 235°C
  • Maximum: 300°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] ±2°C [TBD] [TBD] [TBD] [TBD]
85°C [TBD] [TBD] [TBD] ±2°C [TBD] [TBD] [TBD] [TBD]
160°C [TBD] [TBD] [TBD] ±2°C [TBD] [TBD] [TBD] [TBD]
235°C [TBD] [TBD] [TBD] ±2°C [TBD] [TBD] [TBD] [TBD]
300°C [TBD] [TBD] [TBD] ±2°C [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Heating Mantle Controller is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize at room temperature for at least 30 minutes before calibration.
  3. Performing Readings:
    • Set the controller to each test point.
    • Allow the temperature to stabilize for 5 minutes.
    • Take three replicate readings at each test point.
  4. Calculating Error: Determine the error 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 in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any reading falls outside the acceptance criteria:

  • Stop use of the equipment 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-0159 Heating Mantle Controller Temp QC Chemistry Lab Temperature 20°C – 300°C ±2°C 365 days ISO17025

Pre-calibration

  • [ ] Verify environment conditions are within specifications
  • [ ] Ensure equipment has warmed up adequately
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the temperature setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review
See also  Micropipette 100-1000 µL (CAL-0023) - Calibration Documents

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label
  • [ ] Attach calibration certificate
  • [ ] Obtain reviewer sign-off
  • [ ] 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 Details
Asset Heating Mantle Controller Temp
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-0159 Heating Mantle Controller Temp Heating Mantle QC Chemistry Lab [TBD] [TBD] [TBD] Temperature: 20 – 300 °C ±2°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
20°C [TBD] ±2°C [TBD]
100°C [TBD] ±2°C [TBD]
200°C [TBD] ±2°C [TBD]
250°C [TBD] ±2°C [TBD]
300°C [TBD] ±2°C [TBD]

As Left Results

Test Point Measured Value (°C) Acceptance Criteria Pass/Fail
20°C [TBD] ±2°C [TBD]
100°C [TBD] ±2°C [TBD]
200°C [TBD] ±2°C [TBD]
250°C [TBD] ±2°C [TBD]
300°C [TBD] ±2°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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