Stability Chamber Temp Probe (CAL-0180) – Calibration Documents

Calibration Documents: Stability Chamber Temp Probe (CAL-0180)

Asset ID CAL-0180
Equipment Stability Chamber Temp Probe
Equipment Type Temperature Probe
Department Stability
Area/Location Stability Room
Process Use ICH stability
Parameter Temperature
Units °C
Range Min 0
Range Max 60
Acceptance Criteria ±0.5°C
Calibration Frequency (days) 180
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 Stability Chamber Temperature Probe (CAL-0180) is performed to ensure accurate temperature measurements within the stability room. This calibration controls risks associated with data integrity, patient safety, and batch quality by ensuring that the temperature remains within specified limits during ICH stability testing.

2. Scope

  • Asset ID: CAL-0180
  • Equipment Name/Type: Stability Chamber Temp Probe / Temperature Probe
  • Department/Area: Stability / Stability Room
  • Process Use: ICH stability
  • Parameter: Temperature
  • Range: 0°C to 60°C
  • Units: °C
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement device to a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement device meets specified requirements.
  • Adjustment: The process of modifying a measurement device to bring it into compliance with standards.
  • 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 falls outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement device’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 of a measurement lies.
  • Intermediate Check: A verification process conducted between scheduled calibrations to ensure continued 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 for compliance.
  • Owner Department: Ensure equipment is available and accessible 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 specifications.
  • Maintain cleanliness in the calibration area.
  • Check that the equipment is level and properly positioned.
  • Verify power supply is stable and within specifications.
See also  Standard Weights Set F1 (CAL-0281) - Calibration Documents

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure 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 (0°C and 60°C) and midpoints (15°C, 30°C, 45°C).
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the temperature probe to stabilize in the environment.
  3. As Found checks and data capture: Record initial temperature readings at specified points.
  4. Adjustment rules: If OOT is found, escalate for adjustment as per SOP.
  5. As Left verification: Record final readings after any adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.5°C

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of 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 document deviation.
  • Impact assessment trigger: Review affected results/batches within the impact window.
  • 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 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
  • Calibration tools prepared
  • 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-0180 Stability Chamber Temp Probe Temperature Probe Stability Stability Room ICH stability Temperature °C 0 – 60 ±0.5°C 180 days External ISO17025
See also  Steam Pressure Gauge (CAL-0323) - Calibration Documents

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Min: 0°C
  • 25%: 15°C
  • 50%: 30°C
  • 75%: 45°C
  • Max: 60°C

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
15°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
30°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
45°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
60°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the stability chamber is clean and free from any obstructions.
  2. Stabilization: Allow the stability chamber to stabilize at the test points for a minimum of [TBD] hours.
  3. Performing Readings: Take at least three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading using the formula: Error = Observed Value – Reference Value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±0.5°C.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • 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-0180 Stability Chamber Temp Probe Stability Stability Room Temperature 0 to 60 °C ±0.5°C 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure temperature probe has warmed up adequately
  • [ ] Clean the equipment as per SOP
  • [ ] Level the temperature probe if necessary
  • [ ] Confirm reference standards are valid and calibrated
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set temperature probe to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for analysis

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the temperature probe immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP
See also  Reference Thermometer (Master) (CAL-0051) - Calibration Documents

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 documentation
  • [ ] Update next due date for calibration

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 Stability Chamber Temp Probe
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 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: [Calculated based on calibration_frequency_days]

Asset Details

Asset ID Equipment Name Equipment Type Dept Area Make/Model Serial No Location Parameter/Range/Units Acceptance Criteria
CAL-0180 Stability Chamber Temp Probe Temperature Probe Stability Stability Room [TBD] [TBD] [TBD] Temperature: 0 – 60 °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)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

As Left Results

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