CO2 Incubator RH Sensor (CAL-0307) – Calibration Documents

Calibration Documents: CO2 Incubator RH Sensor (CAL-0307)

Asset ID CAL-0307
Equipment CO2 Incubator RH Sensor
Equipment Type RH Sensor
Department Biologics
Area/Location Cell Culture
Process Use Humidity
Parameter Humidity
Units %RH
Range Min 50
Range Max 95
Acceptance Criteria ±5%RH
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 CO2 Incubator RH Sensor is performed to ensure accurate measurement of humidity within the specified range. This calibration controls risks associated with patient safety, batch quality, and data integrity by ensuring that the equipment operates within defined parameters, thereby maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0307
  • Equipment Name/Type: CO2 Incubator RH Sensor
  • Department/Area: Biologics / Cell Culture
  • Process Use: Humidity
  • Parameter: Humidity
  • Range: 50%RH to 95%RH
  • Units: %RH
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device to a known standard to ensure accuracy.
  • Verification: The confirmation that a measurement device meets specified requirements.
  • Adjustment: The process of altering a measurement device to bring it into compliance with standards.
  • As Found: The condition of the equipment prior to any adjustments.
  • As Left: The condition of the equipment 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 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 performed between 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 documentation.
  • QC/QA Reviewer: Review calibration records 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 guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply is stable and within specifications.
See also  AAS (CAL-0115) - Calibration Documents

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. A minimum of 5 measurement points will be taken, including endpoints (50%RH and 95%RH) and midpoints. Each point will have 3 replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the RH sensor to stabilize in the environment.
  3. As Found checks and data capture: Record initial readings at defined points.
  4. Adjustment rules: If OOT is found, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Confirm that all adjustments bring the equipment within acceptance criteria.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±5%RH from the target values. The error calculation formula is:

Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If the error falls within the acceptance criteria, the calibration is considered a pass; otherwise, it is a fail.

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 defined impact window.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Maintain detailed records of all calibration activities.
  • Calibration report/certificate filing: Store all calibration certificates 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 stabilized
  • All tools available
  • Documentation ready

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

⬆ Back to TOC

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-0307 CO2 Incubator RH Sensor RH Sensor Biologics Cell Culture Humidity Humidity %RH 50 – 95 ±5%RH 365 days External ISO17025
See also  GC System (CAL-0122) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 50% RH
  • 25% Point: 62.5% RH
  • 50% Point: 72.5% RH
  • 75% Point: 82.5% RH
  • Maximum: 95% RH

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
50% RH [TBD] [TBD] [TBD] ±5%RH [TBD] [TBD] [TBD] [TBD]
62.5% RH [TBD] [TBD] [TBD] ±5%RH [TBD] [TBD] [TBD] [TBD]
72.5% RH [TBD] [TBD] [TBD] ±5%RH [TBD] [TBD] [TBD] [TBD]
82.5% RH [TBD] [TBD] [TBD] ±5%RH [TBD] [TBD] [TBD] [TBD]
95% RH [TBD] [TBD] [TBD] ±5%RH [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the CO2 Incubator is powered on and functioning properly.
  2. Stabilization: Allow the incubator to stabilize for at least [TBD] hours before calibration.
  3. Performing Readings: Take at least three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±5%RH.
  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 supervisor 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]

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0307 CO2 Incubator RH Sensor Biologics Cell Culture Humidity 50 – 95 %RH ±5%RH 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
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the initial setpoints for humidity
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Vacuum Gauge (-1 to 0 bar) (CAL-0073) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm 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 results
  • [ ] Update next due date for calibration

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

⬆ Back to TOC

Deviation Impact Assessment

Event Summary
Asset: CO2 Incubator RH 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: [TBD] to discovery date: [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]

⬆ Back to TOC

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-0307 CO2 Incubator RH Sensor RH Sensor Biologics Cell Culture [TBD] [TBD] [TBD] Humidity: 50-95 %RH ±5%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) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

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

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: ______________________ Date: ____________

⬆ Back to TOC