Photo-stability Chamber UV (CAL-0185) – Calibration Documents

Calibration Documents: Photo-stability Chamber UV (CAL-0185)

Asset ID CAL-0185
Equipment Photo-stability Chamber UV
Equipment Type UV Radiometer
Department Stability
Area/Location Photostability
Process Use UV exposure
Parameter UV
Units W/m2
Range Min 0
Range Max 100
Acceptance Criteria As per method
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 Photo-stability Chamber UV is performed to ensure the accuracy of UV exposure measurements, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate UV measurements are essential in stability studies to determine the effect of light on the stability of pharmaceutical products.

2. Scope

  • Asset ID: CAL-0185
  • Equipment Name/Type: Photo-stability Chamber UV / UV Radiometer
  • Department/Area: Stability / Photostability
  • Process Use: UV exposure
  • Parameter: UV
  • Range: 0 – 100 W/m²
  • Units: W/m²
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The confirmation that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
  • 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 falls outside the specified acceptance criteria.
  • Drift: The gradual change in the accuracy 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 dispersion of values attributed to a measurement.
  • Intermediate Check: A verification step performed 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 maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • 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 equipment as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply checks are completed before calibration.
See also  Stopwatch (CAL-0262) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the specified range of 0 to 100 W/m². Each point should 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 equipment to stabilize as per manufacturer guidelines.
  3. As Found Checks and Data Capture: Record initial readings at each test point.
  4. Adjustment Rules: If any readings are OOT, follow adjustment protocols if allowed; otherwise, escalate to QA.
  5. As Left Verification: Record final readings after adjustments.
  6. Labeling + Documentation Completion: Ensure all records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: As per method. The error calculation formula will be: Error = (Observed Value – Reference Value) / Reference Value × 100%. Pass/Fail logic will be based on whether the error falls within acceptable limits. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use until resolved.
  • Notification & deviation initiation: Inform relevant personnel of the OOT condition.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure equipment is recalibrated post-repair.
  • QA disposition placeholders: [TBD].

12. Records & Retention

  • Logbook entries must be made for each calibration event.
  • Calibration report/certificate filing must be maintained.
  • 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 checked
  • Leveling confirmed
  • 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-0185 Photo-stability Chamber UV UV Radiometer Stability Photostability UV exposure UV W/m2 0 – 100 As per method 365 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 W/m2
  • 25% of Range: 25 W/m2
  • 50% of Range: 50 W/m2
  • 75% of Range: 75 W/m2
  • Maximum: 100 W/m2

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 W/m2 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
25 W/m2 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 W/m2 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
75 W/m2 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
100 W/m2 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Photo-stability Chamber UV is clean and calibrated as per the previous records.
  2. Stabilization: Allow the equipment to stabilize for [TBD] hours before performing readings.
  3. Performing Readings: Take three replicates at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

In the event of an Out of Tolerance (OOT) result:

  • Stop use of the equipment immediately.
  • Notify the Quality Assurance (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-0185 Photo-stability Chamber UV Stability Photostability UV 0 – 100 W/m2 As per method 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up for the required duration
  • [ ] Clean the equipment as per SOP
  • [ ] Ensure the equipment is level
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for data entry

As Found Execution

  • [ ] Set equipment to specified setpoints
  • [ ] Perform required number of repeats
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review
See also  Autoclave Chart Recorder Pressure (CAL-0221) - Calibration Documents

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm results are within specified 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 recorded is Attributable, Legible, Contemporaneous, Original, and Accurate.

Out of Tolerance (OOT) Handling: Follow established procedures for addressing OOT results to ensure compliance and quality assurance.

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Deviation Impact Assessment

Event Summary
Asset: Photo-stability Chamber UV
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 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-0185 Photo-stability Chamber UV UV Radiometer Stability Photostability [TBD] [TBD] [TBD] UV (0 – 100 W/m2) As per method

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 (W/m2) Acceptance Criteria
1 [TBD] As per method
2 [TBD] As per method
3 [TBD] As per method
4 [TBD] As per method
5 [TBD] As per method

As Left Results

Test Point Measured Value (W/m2) Acceptance Criteria
1 [TBD] As per method
2 [TBD] As per method
3 [TBD] As per method
4 [TBD] As per method
5 [TBD] As per method

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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