Stability Chamber RH Probe (CAL-0181) – Calibration Documents

Calibration Documents: Stability Chamber RH Probe (CAL-0181)

Asset ID CAL-0181
Equipment Stability Chamber RH Probe
Equipment Type Humidity Sensor
Department Stability
Area/Location Stability Room
Process Use ICH stability
Parameter Humidity
Units %RH
Range Min 10
Range Max 90
Acceptance Criteria ±3%RH
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 RH Probe is performed to ensure accurate measurement of humidity levels within the stability room. This calibration controls risks related to data integrity, patient safety, and batch quality by ensuring that the equipment operates within specified limits, thereby maintaining compliance with ICH stability requirements.

2. Scope

  • Asset ID: CAL-0181
  • Equipment Name/Type: Stability Chamber RH Probe / Humidity Sensor
  • Department/Area: Stability / Stability Room
  • Process Use: ICH stability
  • Parameter: Humidity
  • Range: 10%RH to 90%RH
  • Units: %RH
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
  • Verification: The process of confirming 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 established acceptance criteria.
  • Drift: The gradual change in the measurement accuracy of an instrument 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 performed between calibrations to ensure continued accuracy of the instrument.

4. References

  • Company Metrology SOP [TBD]
  • ISO/IEC 17025 traceability via calibration certificates
  • ALCOA+ principles

5. Responsibilities

  • Technician/Metrology: Perform calibration and maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure equipment is available and properly 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 guidelines.
  • Maintain cleanliness of the calibration area.
  • Check leveling of the equipment.
  • Verify power supply stability.
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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 then As Left logic. The minimum number of points for calibration will be 5, including endpoints and midpoints of the specified range (10%RH to 90%RH). It is recommended to take 3 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 stability chamber to reach operating conditions.
  3. As Found checks and data capture: Record initial readings at specified points.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Confirm that adjustments bring the instrument within acceptance criteria.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±3%RH. The error calculation formula is: Error = (Observed Value – True Value). Pass/Fail logic: If the absolute value of the error is within acceptance criteria, the result is a pass; otherwise, it is a fail. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Inform relevant personnel.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure equipment is recalibrated before use.
  • QA disposition placeholders: [TBD].

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with company policy.
  • e-Records if applicable: [TBD].
  • Label content requirements: Calibrated date, due date, by whom, 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 warmed up
  • Calibration area clean
  • Equipment leveled
  • Power supply checked

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-0181 Stability Chamber RH Probe Humidity Sensor Stability Stability Room ICH stability Humidity %RH 10 – 90 ±3%RH 180 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 10% RH
  • 25%: 27.5% RH
  • 50%: 50% RH
  • 75%: 72.5% RH
  • Maximum: 90% RH

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
10% RH 10% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
27.5% RH 27.5% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
50% RH 50% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
72.5% RH 72.5% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]
90% RH 90% RH [TBD] [TBD] ±3%RH [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the stability chamber is clean and operational.
  2. Stabilization: Allow the chamber to stabilize at the desired test points for a minimum of 30 minutes.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading as follows: Error = Observed Value – Ref Value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment.
  • Notify the QA department immediately.
  • 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-0181 Stability Chamber RH Probe Stability Stability Room Humidity 10%RH – 90%RH ±3%RH 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the probe and surrounding area
  • [ ] Ensure equipment is level
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for entries

As Found Execution

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

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process
See also  Stability Chamber Controller Display RH (CAL-0183) - Calibration Documents

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] Attach calibration certificate to documentation
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Stability Chamber RH Probe
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 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-0181 Stability Chamber RH Probe Humidity Sensor Stability Stability Room [TBD] [TBD] [TBD] Humidity: 10 – 90 %RH ±3%RH

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 (%RH) Acceptance Criteria Pass/Fail
1 [TBD] ±3%RH [TBD]
2 [TBD] ±3%RH [TBD]
3 [TBD] ±3%RH [TBD]
4 [TBD] ±3%RH [TBD]
5 [TBD] ±3%RH [TBD]

As Left Results

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