HEPA Filter Leak Tester (Aerosol photometer) (CAL-0172) – Calibration Documents

Calibration Documents: HEPA Filter Leak Tester (Aerosol photometer) (CAL-0172)

Asset ID CAL-0172
Equipment HEPA Filter Leak Tester (Aerosol photometer)
Equipment Type HEPA Leak Tester
Department HVAC
Area/Location Cleanroom
Process Use HEPA integrity
Parameter Leak %
Units %
Range Min 0
Range Max 100
Acceptance Criteria As per ISO14644
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 HEPA Filter Leak Tester (Aerosol photometer) is performed to ensure the accuracy of leak percentage measurements critical for maintaining HEPA integrity in cleanroom environments. This calibration controls risks related to patient safety, batch quality, and data integrity, ensuring compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0172
  • Equipment Name/Type: HEPA Filter Leak Tester (Aerosol photometer)
  • Department/Area: HVAC / Cleanroom
  • Process Use: HEPA integrity
  • Parameter: Leak %
  • Range: 0% – 100%
  • Units: %
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
  • Verification: Confirming that a measurement instrument is functioning correctly.
  • Adjustment: Modifying a measurement instrument to bring it into compliance with 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 exceeds specified limits.
  • Drift: The gradual change in a measurement instrument’s output over time.
  • Traceability: The ability to trace the history, application, or location of an item through 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 verification 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 document results.
  • QC/QA Reviewer: Review calibration documentation for 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 equipment as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check equipment leveling and stability.
  • Verify power supply is stable and within specifications.
See also  Reference Thermometer (Master) (CAL-0051) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of test points will be 5, including endpoints and midpoints within the range of 0% to 100%. Each point will have 3 replicate readings as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the HEPA Filter Leak Tester to stabilize as per manufacturer instructions.
  3. As Found checks and data capture: Record initial measurements at defined test points.
  4. Adjustment rules: If OOT is found, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria are as per ISO14644. The error calculation formula will be: Error = (Observed Value – True Value) / True 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.
  • 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: 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 accordance with company policy.
  • 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
  • Cleanliness confirmed
  • Leveling checked
  • Power supply stable

Annexure C: Example Label Text

Calibration Date: [TBD]
Due Date: [TBD]
Calibrated By: [TBD]
Status: [TBD]

See also  Graduated Cylinder 250 mL (CAL-0044) - Calibration Documents

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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-0172 HEPA Filter Leak Tester (Aerosol photometer) HEPA Leak Tester HVAC Cleanroom HEPA integrity Leak % % 0 – 100 As per ISO14644 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0%
  • 25%: 25%
  • 50%: 50%
  • 75%: 75%
  • Maximum: 100%

Results Table

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

Stepwise Instructions

  1. Preparation: Ensure the HEPA Filter Leak Tester is clean and calibrated as per the last calibration record.
  2. Stabilization: Allow the equipment to stabilize for [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 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 all data is compliant with ALCOA+ principles.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance personnel.
  • 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-0172 HEPA Filter Leak Tester (Aerosol photometer) HVAC Cleanroom Leak % 0 – 100 % As per ISO14644 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the equipment as per SOP
  • [ ] Ensure equipment is level
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for entries
See also  Depyrogenation Tunnel Temp Sensor (CAL-0222) - Calibration Documents

As Found Execution

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

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct 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 recorded is Attributable, Legible, Contemporaneous, Original, and Accurate.

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Deviation Impact Assessment

Event Summary Details
Asset HEPA Filter Leak Tester (Aerosol photometer)
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

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-0172 HEPA Filter Leak Tester (Aerosol photometer) HEPA Leak Tester HVAC Cleanroom [TBD] [TBD] [TBD] Leak % (0 – 100 %) As per ISO14644

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Leak %
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

As Left Results

Test Point Leak %
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [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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