CO2 Incubator CO2 Sensor (CAL-0305) – Calibration Documents

Calibration Documents: CO2 Incubator CO2 Sensor (CAL-0305)

Asset ID CAL-0305
Equipment CO2 Incubator CO2 Sensor
Equipment Type CO2 Sensor
Department Biologics
Area/Location Cell Culture
Process Use CO2
Parameter CO2
Units %CO2
Range Min 0
Range Max 20
Acceptance Criteria ±0.5%
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 CO2 Incubator CO2 Sensor is performed to ensure accurate measurement of CO2 levels within the specified range. This calibration controls risks associated with accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP) in the Biologics department.

2. Scope

  • Asset ID: CAL-0305
  • Equipment Name/Type: CO2 Incubator CO2 Sensor
  • Department/Area: Biologics / Cell Culture
  • Process Use: CO2
  • Parameter: CO2
  • Range: 0%CO2 to 20%CO2
  • Units: %CO2
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
  • Verification: The process of confirming that an instrument is functioning correctly.
  • Adjustment: The act of modifying an instrument to bring it within specified limits.
  • 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 exceeds the acceptance criteria.
  • Drift: The gradual change in an 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 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 document results.
  • QC/QA Reviewer: Review calibration documentation for compliance.
  • Owner Department: Ensure equipment is available and maintained.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer specifications.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
See also  Burette 50 mL (CAL-0030) - Calibration Documents

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within their validity period.

8. Calibration Strategy

Calibration will follow an As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints of the specified range (0%CO2 to 20%CO2). Each point should have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the CO2 Incubator to stabilize for the recommended period.
  3. As Found checks and data capture: Measure CO2 levels and record initial readings.
  4. Adjustment rules: If any readings are OOT, follow the adjustment protocol; if not allowed, escalate to QA.
  5. As Left verification: Re-measure CO2 levels to confirm adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the CO2 sensor calibration is ±0.5%. The error calculation formula is:

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

Pass/Fail logic: If the error falls within ±0.5%, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop its use.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries must include all calibration activities.
  • Calibration report/certificate filing should be maintained for audit purposes.
  • 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 and stabilized
  • Cleanliness checked
  • Leveling confirmed
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

See also  Tank Level Transmitter (CAL-0205) - Calibration Documents

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-0305 CO2 Incubator CO2 Sensor CO2 Sensor Biologics Cell Culture CO2 CO2 %CO2 0 – 20 ±0.5% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Min: 0% CO2
  • 25%: 5% CO2
  • 50%: 10% CO2
  • 75%: 15% CO2
  • Max: 20% CO2

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0% CO2 0% [TBD] [TBD] ±0.5% [TBD] [TBD] [TBD] [TBD]
5% CO2 5% [TBD] [TBD] ±0.5% [TBD] [TBD] [TBD] [TBD]
10% CO2 10% [TBD] [TBD] ±0.5% [TBD] [TBD] [TBD] [TBD]
15% CO2 15% [TBD] [TBD] ±0.5% [TBD] [TBD] [TBD] [TBD]
20% CO2 20% [TBD] [TBD] ±0.5% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the CO2 incubator is clean and free from contaminants.
  2. Stabilization: Allow the equipment to stabilize for at least [TBD] minutes before calibration.
  3. Performing Readings: Take three replicate measurements 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 ±0.5%.
  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 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-0305 CO2 Incubator CO2 Sensor Biologics Cell Culture CO2 0 – 20 %CO2 ±0.5% 180 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Load Cell (Loss-in-weight feeder) (CAL-0013) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] Attach calibration certificate to records
  • [ ] 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
Asset: CO2 Incubator CO2 Sensor
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/Re-Test/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-0305 CO2 Incubator CO2 Sensor CO2 Sensor Biologics Cell Culture [TBD] [TBD] [TBD] CO2: 0 – 20 %CO2 ±0.5%

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Measured Value (%CO2) Acceptance Criteria
1 [TBD] ±0.5%
2 [TBD] ±0.5%
3 [TBD] ±0.5%
4 [TBD] ±0.5%
5 [TBD] ±0.5%

As Left Results

Test Point Measured Value (%CO2) Acceptance Criteria
1 [TBD] ±0.5%
2 [TBD] ±0.5%
3 [TBD] ±0.5%
4 [TBD] ±0.5%
5 [TBD] ±0.5%

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: _____________________ Date: ___________

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