Photo-stability Chamber Lux (CAL-0184) – Calibration Documents

Calibration Documents: Photo-stability Chamber Lux (CAL-0184)

Asset ID CAL-0184
Equipment Photo-stability Chamber Lux
Equipment Type Photostability Lux Meter
Department Stability
Area/Location Photostability
Process Use Light exposure
Parameter Illuminance
Units lux
Range Min 0
Range Max 10000
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 Lux is performed to ensure accurate measurement of illuminance, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate light exposure is essential in stability studies to determine the shelf life and efficacy of pharmaceutical products.

2. Scope

  • Asset ID: CAL-0184
  • Equipment Name/Type: Photo-stability Chamber Lux / Photostability Lux Meter
  • Department/Area: Stability / Photostability
  • Process Use: Light exposure
  • Parameter: Illuminance
  • Range: 0 – 10000 lux
  • Units: lux
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device against a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement device is functioning correctly.
  • Adjustment: The act of modifying a measurement device to bring it into alignment with a standard.
  • As Found: The state of the measurement device prior to any adjustments.
  • As Left: The state of the measurement device after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement device does not meet specified acceptance criteria.
  • Drift: The gradual change in a measurement device’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 a measurement device to ensure it remains within specified limits 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 per schedule.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm-up and stabilize as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply is stable and within specifications.
See also  Burette 10 mL (CAL-0028) - 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:

  • Minimum number of points: At least 5 points including endpoints and midpoints within the range of 0 – 10000 lux.
  • Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the equipment to stabilize as per manufacturer recommendations.
  3. As Found checks and data capture: Record initial readings at all defined points.
  4. Adjustment rules: If OOT is detected, follow adjustment procedures if allowed; otherwise, escalate to QA.
  5. As Left verification: Record final readings after any adjustments.
  6. Labeling + documentation completion: Ensure all records are completed and raw observations are documented contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: As per method.

Error calculation formula: Error (%) = (Measured Value – True Value) / True Value × 100

Pass/Fail Logic: If the error falls within acceptable limits, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records of calibration certificates.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, by whom, 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
  • 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-0184 Photo-stability Chamber Lux Photostability Lux Meter Stability Photostability Light exposure Illuminance lux 0 – 10000 As per method 365 days External ISO17025
See also  HPLC System (CAL-0120) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

  • Minimum: 0 lux
  • 25% of Range: 2500 lux
  • 50% of Range: 5000 lux
  • 75% of Range: 7500 lux
  • Maximum: 10000 lux

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 lux [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2500 lux [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
5000 lux [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
7500 lux [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
10000 lux [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Photo-stability Chamber Lux is clean and calibrated prior to use.
  2. Stabilization: Allow the equipment to stabilize for [TBD] 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 against the reference value.
  5. Evaluation: Compare the observed values against the acceptance criteria.
  6. Documentation: Record all findings in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value is out of tolerance (OOT):

  • 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-0184 Photo-stability Chamber Lux Stability Photostability Illuminance 0 – 10000 lux As per method 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

As Found Execution

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

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review as per SOP
See also  Balance Calibration Weight 1 g (CAL-0330) - Calibration Documents

As Left Verification

  • [ ] Conduct post-adjustment checks to confirm settings
  • [ ] Ensure all measurements are within specified limits

Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] Attach calibration certificate to documentation
  • [ ] Obtain reviewer sign-off on calibration report
  • [ ] Update next due date in logbook

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary Details
Asset Photo-stability Chamber Lux
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 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

Summary of investigation findings: [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-0184 Photo-stability Chamber Lux Photostability Lux Meter Stability Photostability [TBD] [TBD] [TBD] Illuminance (0 – 10000 lux) 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 (lux) 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 (lux) 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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