TOC Analyzer Online (CAL-0097) – Calibration Documents

Calibration Documents: TOC Analyzer Online (CAL-0097)

Asset ID CAL-0097
Equipment TOC Analyzer Online
Equipment Type Online TOC Analyzer
Department Utilities
Area/Location WFI Loop
Process Use TOC
Parameter TOC
Units ppb
Range Min 0
Range Max 1000
Acceptance Criteria ±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 TOC Analyzer Online is performed to ensure accurate measurement of Total Organic Carbon (TOC) levels in the Water for Injection (WFI) loop. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0097
  • Equipment Name/Type: TOC Analyzer Online / Online TOC Analyzer
  • Department/Area: Utilities / WFI Loop
  • Process Use: TOC
  • Parameter: TOC
  • Range: 0 – 1000 ppb
  • Units: ppb
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • 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 specifications.
  • As Found: The condition of the instrument before calibration.
  • As Left: The condition of the instrument after calibration.
  • OOT (Out of Tolerance): A condition where the measurement results fall outside the specified acceptance criteria.
  • Drift: The gradual change in the output of a measurement instrument over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • 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 documentation and results.
  • Owner Department: Ensure equipment is available and maintained.
  • External Service Provider: Conduct external calibration as per schedule.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the instrument as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the instrument.
  • Verify power supply stability.
See also  Hot Air Oven Temp Sensor (CAL-0154) - Calibration Documents

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. A minimum of 5 calibration points will be taken, including endpoints and midpoints of the specified range (0 – 1000 ppb). Each point will have 3 replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the TOC Analyzer to stabilize as per manufacturer guidelines.
  3. As Found Checks: Record initial readings and data capture for all calibration points.
  4. Adjustment Rules: If OOT is detected, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left Verification: Confirm that the instrument is within tolerance after adjustments.
  6. Labeling + Documentation Completion: Ensure all calibration records are completed and labeled appropriately.

Record raw observations contemporaneously to maintain ALCOA+ standards.

10. Acceptance Criteria & Calculations

Acceptance criteria for the calibration of the TOC Analyzer is ±5%. The error calculation formula is as follows:

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

Pass/Fail Logic: If the error is within ±5%, 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 until resolved.
  • Notification: Notify QA and initiate deviation process.
  • Impact Assessment Trigger: Define impact window and review affected results/batches.
  • Recalibration: Conduct recalibration after repair or adjustment.
  • QA Disposition: [TBD]

12. Records & Retention

  • Logbook entries must be maintained for all calibrations.
  • Calibration report/certificate filing must be organized and accessible.
  • 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 warm-up completed
  • Cleanliness confirmed
  • Leveling checked
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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See also  BOD Incubator Temp Sensor (CAL-0157) - Calibration Documents

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-0097 TOC Analyzer Online Online TOC Analyzer Utilities WFI Loop TOC TOC ppb 0 – 1000 ±5% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]
Relative Humidity: [TBD]
Vibration: [TBD]
Drafts: [TBD]

Test Point Selection

Test points based on the range of 0 to 1000 ppb:

  • Min: 0 ppb
  • 25%: 250 ppb
  • 50%: 500 ppb
  • 75%: 750 ppb
  • Max: 1000 ppb

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 ppb [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
250 ppb [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
500 ppb [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
750 ppb [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
1000 ppb [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the TOC Analyzer is clean and calibrated according to the manufacturer’s specifications.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±5%.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria, follow these steps:
1. Stop use of the equipment immediately.
2. Notify the QA department.
3. Open a deviation report.
4. Quarantine impacted results window: [TBD].
5. 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-0097 TOC Analyzer Online Utilities WFI Loop TOC 0 – 1000 ppb ±5% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up for the required duration
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation
See also  Torque Wrench (Packaging) (CAL-0264) - Calibration Documents

As Found Execution

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

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify relevant personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review process

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 is attributable, legible, contemporaneous, original, accurate, and complete.

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Deviation Impact Assessment

Event Summary
Asset: TOC Analyzer Online
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]

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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-0097 TOC Analyzer Online Online TOC Analyzer Utilities WFI Loop [TBD] [TBD] [TBD] TOC / 0 – 1000 / ppb ±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 Result (ppb)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

As Left Results

Test Point Result (ppb)
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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