UV-Vis Spectrophotometer (CAL-0110) – Calibration Documents

Calibration Documents: UV-Vis Spectrophotometer (CAL-0110)

Asset ID CAL-0110
Equipment UV-Vis Spectrophotometer
Equipment Type UV-Vis
Department QC
Area/Location Instrument Room
Process Use Assay
Parameter Wavelength
Units nm
Range Min 190
Range Max 800
Acceptance Criteria ±1 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 UV-Vis Spectrophotometer (CAL-0110) is performed to ensure accurate wavelength measurements, which are critical for assay processes. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity.

2. Scope

  • Asset ID: CAL-0110
  • Equipment Name/Type: UV-Vis Spectrophotometer / UV-Vis
  • Department/Area: QC / Instrument Room
  • Process Use: Assay
  • Parameter: Wavelength
  • Range: 190 nm – 800 nm
  • Units: nm
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument.
  • Verification: Confirming that an instrument meets specified requirements.
  • Adjustment: Modifying an 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 exceeds specified acceptance criteria.
  • Drift: The gradual change in an instrument’s measurement over time.
  • Traceability: The ability to trace the measurement 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 periodic assessment of an 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 record data.
  • QC/QA Reviewer: Review calibration records and ensure 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 for warm-up/stabilization of the instrument as per manufacturer guidelines.
  • Maintain cleanliness of the instrument and surrounding area.
  • Check leveling of the instrument.
  • Verify power supply stability.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be 5, including endpoints and midpoints within the specified range of 190 nm to 800 nm. Each point will have 3 replicate readings to ensure accuracy.

See also  Reference Hygrometer (Master) (CAL-0061) - Calibration Documents

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the instrument to warm up for the specified time.
  3. As Found checks and data capture: Measure the wavelength at defined points and record data contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is found, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Confirm adjustments and recheck measurements.
  6. Labeling + documentation completion: Complete all required documentation and label the instrument appropriately.

10. Acceptance Criteria & Calculations

The acceptance criteria for the UV-Vis Spectrophotometer is ±1 nm. The error calculation formula is:

Error = Observed Value – Reference Value

Pass/Fail Logic: If the absolute value of the error is within the acceptance criteria, the calibration 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: Assess the impact on results/batches within the defined impact window.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries must be made for each calibration.
  • Calibration report/certificate filing must be maintained.
  • E-records if applicable: [TBD]
  • Label content requirements: 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
  • Instrument warm-up completed
  • Cleanliness checked
  • Leveling confirmed
  • Power supply stable

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-0110 UV-Vis Spectrophotometer UV-Vis QC Instrument Room Assay Wavelength nm 190 – 800 ±1 nm 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

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Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for Wavelength (nm):

  • Min: 190
  • 25%: 297.5
  • 50%: 495
  • 75%: 692.5
  • Max: 800

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
190 [TBD] [TBD] [TBD] ±1 nm [TBD] [TBD] [TBD] [TBD]
297.5 [TBD] [TBD] [TBD] ±1 nm [TBD] [TBD] [TBD] [TBD]
495 [TBD] [TBD] [TBD] ±1 nm [TBD] [TBD] [TBD] [TBD]
692.5 [TBD] [TBD] [TBD] ±1 nm [TBD] [TBD] [TBD] [TBD]
800 [TBD] [TBD] [TBD] ±1 nm [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the UV-Vis Spectrophotometer is clean and calibrated prior to testing.
  2. Stabilization: Allow the instrument to warm up for at least [TBD] minutes.
  3. Performing Readings:
    • Take 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 error against the acceptance criteria of ±1 nm.
  6. Documentation: Record all results in the results table above.

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 By Reviewed By Approved By
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0110 UV-Vis Spectrophotometer QC Instrument Room Wavelength 190 – 800 nm ±1 nm 365 days ISO17025

1. Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the optical surfaces and sample compartment
  • [ ] Level the instrument if applicable
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

2. As Found Execution

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

3. OOT Immediate Actions

  • [ ] Tag out the instrument if out of tolerance (OOT)
  • [ ] Stop use of the instrument immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process

4. As Left Verification

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

5. Documentation & Closure

  • [ ] Update calibration label with new date
  • [ ] Attach calibration certificate to logbook
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in the system
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Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

Acceptance Criteria: Results must be within ±1 nm of the specified wavelength.

As Found/As Left: Document the condition of the instrument before and after calibration.

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Deviation Impact Assessment

Event Summary
Asset: UV-Vis Spectrophotometer
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

Summary: [TBD]
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-0110 UV-Vis Spectrophotometer UV-Vis QC Instrument Room [TBD] [TBD] [TBD] Wavelength: 190 – 800 nm ±1 nm

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 (nm) Acceptance Criteria Pass/Fail
190 [TBD] ±1 nm [TBD]
300 [TBD] ±1 nm [TBD]
400 [TBD] ±1 nm [TBD]
500 [TBD] ±1 nm [TBD]
800 [TBD] ±1 nm [TBD]

As Left Results

Test Point Measured Value (nm) Acceptance Criteria Pass/Fail
190 [TBD] ±1 nm [TBD]
300 [TBD] ±1 nm [TBD]
400 [TBD] ±1 nm [TBD]
500 [TBD] ±1 nm [TBD]
800 [TBD] ±1 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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