Fluorescence Spectrophotometer (CAL-0114) – Calibration Documents

Calibration Documents: Fluorescence Spectrophotometer (CAL-0114)

Asset ID CAL-0114
Equipment Fluorescence Spectrophotometer
Equipment Type Fluorimeter
Department QC
Area/Location Instrument Room
Process Use Fluorescence
Parameter Wavelength
Units nm
Range Min 200
Range Max 900
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 Fluorescence Spectrophotometer (CAL-0114) is performed to ensure the accuracy of wavelength measurements within the specified range. This calibration controls risks related to patient safety, batch quality, and data integrity by confirming that the instrument operates within acceptable limits, thereby ensuring reliable analytical results.

2. Scope

  • Asset ID: CAL-0114
  • Equipment Name/Type: Fluorescence Spectrophotometer / Fluorimeter
  • Department/Area: QC / Instrument Room
  • Process Use: Fluorescence
  • Parameter: Wavelength
  • Range: 200 nm to 900 nm
  • Units: nm
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument against a known standard.
  • Verification: Confirmation that the instrument meets specified requirements.
  • Adjustment: The process of correcting 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 calibration and adjustments.
  • OOT (Out of Tolerance): A condition where the instrument measurements fall outside the established 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 periodic check 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 documentation and results.
  • 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 for warm-up/stabilization period as per manufacturer guidelines.
  • Maintain cleanliness of the instrument and surrounding area.
  • Check leveling of the instrument before calibration.
  • Verify power supply stability and functionality.
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7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints (200 nm and 900 nm) and midpoints. Each point will have three replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the instrument to warm up for the specified time.
  3. As Found checks and data capture: Measure the wavelength at specified points and record the data contemporaneously (ALCOA+).
  4. Adjustment rules: If any measurement is OOT, follow the adjustment protocol; if adjustments are not allowed, escalate to QA.
  5. As Left verification: Re-measure the points after adjustments to confirm compliance.
  6. Labeling + documentation completion: Complete all required documentation and label the instrument with calibration details.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Fluorescence Spectrophotometer 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 the acceptance criteria, 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: Schedule recalibration once issues are resolved.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain records of calibration reports and certificates.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and calibration 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 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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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-0114 Fluorescence Spectrophotometer Fluorimeter QC Instrument Room Fluorescence Wavelength nm 200 – 900 ±2 nm 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the specified range of 200 nm to 900 nm. The following points will be used:

  • 200 nm (Min)
  • 325 nm (25%)
  • 500 nm (50%)
  • 675 nm (75%)
  • 900 nm (Max)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
200 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
325 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
500 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
675 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]
900 nm [TBD] [TBD] [TBD] ±2 nm [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Fluorescence Spectrophotometer is clean and calibrated as per previous records.
  2. Stabilization: Allow the instrument to warm up for at least [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 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: Record all observations, calculations, and results in the calibration log.

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-0114 Fluorescence Spectrophotometer QC Instrument Room Wavelength 200 – 900 nm ±2 nm 365 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
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As Found Execution

  • [ ] Set the initial measurement setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate 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

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Deviation Impact Assessment

Event Summary
Asset: Fluorescence 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 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/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-0114 Fluorescence Spectrophotometer Fluorimeter QC Instrument Room [TBD] [TBD] [TBD] Wavelength (200 – 900 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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