Chromatography Skid UV Detector (CAL-0312) – Calibration Documents

Calibration Documents: Chromatography Skid UV Detector (CAL-0312)

Asset ID CAL-0312
Equipment Chromatography Skid UV Detector
Equipment Type UV Detector
Department Biologics
Area/Location Downstream
Process Use UV
Parameter Wavelength
Units nm
Range Min 190
Range Max 400
Acceptance Criteria ±2 nm
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 Chromatography Skid UV Detector is performed to ensure accurate wavelength measurements within the specified range. This calibration controls risks related to data integrity, patient safety, and batch quality by ensuring that the detector operates within defined parameters, thereby maintaining compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0312
  • Equipment Name/Type: Chromatography Skid UV Detector / UV Detector
  • Department/Area: Biologics / Downstream
  • Process Use: UV
  • Parameter: Wavelength
  • Range: 190 nm to 400 nm
  • Units: nm
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument.
  • Verification: The confirmation that a measurement system meets specified requirements.
  • Adjustment: The process of modifying a measurement system to bring it into compliance with specifications.
  • 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 defined acceptance criteria.
  • Drift: The gradual change in the measurement 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 dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A periodic verification of the instrument’s performance between calibrations.

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 records and ensure compliance.
  • Owner Department: Ensure equipment availability and maintenance.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the detector as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
See also  BOD Incubator Temp Sensor (CAL-0157) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within valid calibration dates.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of calibration points will be five, including endpoints (190 nm and 400 nm) and midpoints. It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the UV Detector to warm up for the specified time.
  3. As Found checks and data capture: Measure the wavelength at defined points and record results.
  4. Adjustment rules: If any measurements are OOT, perform adjustments as allowed; otherwise, escalate the issue.
  5. As Left verification: Re-measure the wavelength after adjustments and record results.
  6. Labeling + documentation completion: Ensure all calibration records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the wavelength measurement is ±2 nm. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of the error is within ±2 nm, the measurement passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease 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 placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in compliance with company policies.
  • 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 and standards ready
  • Documentation prepared

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-0312 Chromatography Skid UV Detector UV Detector Biologics Downstream UV Wavelength nm 190 – 400 ±2 nm 365 days External ISO17025
See also  Colorimeter (CAL-0233) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 190 nm
  • 25%: 232.5 nm
  • 50%: 295 nm
  • 75%: 357.5 nm
  • Maximum: 400 nm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
190 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
232.5 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
295 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
357.5 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
400 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the UV Detector is clean and free from any contaminants. Verify that the equipment is within the specified environmental conditions.
  2. Stabilization: Allow the UV Detector to warm up for at least [TBD] minutes before taking measurements.
  3. Performing Readings:
    • Take three replicate readings at each test point.
    • Record the observed values in the results table.
  4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed Value – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±2 nm.
  6. Documentation: Complete the results table and ensure all data is recorded accurately to maintain ALCOA+ principles.

Deviation Instruction for OOT

If any observed values fall 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-0312 Chromatography Skid UV Detector Biologics Downstream Wavelength 190 – 400 nm ±2 nm 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment as per cleaning procedure
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Record initial setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
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OOT Immediate Actions

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

As Left Verification

  • [ ] Perform post-adjustment checks
  • [ ] Confirm results 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: Chromatography Skid UV Detector
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-0312 Chromatography Skid UV Detector UV Detector Biologics Downstream [TBD] [TBD] [TBD] Wavelength: 190 – 400 nm ±2 nm

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

As Left Results

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