Flow Hood / Airflow Capture Hood (CAL-0251) – Calibration Documents

Calibration Documents: Flow Hood / Airflow Capture Hood (CAL-0251)

Asset ID CAL-0251
Equipment Flow Hood / Airflow Capture Hood
Equipment Type Airflow Hood
Department HVAC
Area/Location Cleanroom
Process Use Airflow
Parameter Flow
Units m3/h
Range Min 0
Range Max 5000
Acceptance Criteria ±3%
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 Flow Hood / Airflow Capture Hood is performed to ensure accurate airflow measurements within the Cleanroom environment. This is critical for maintaining compliance with Good Manufacturing Practices (GMP) and ensuring patient safety, batch quality, and data integrity. Accurate airflow measurements help mitigate risks associated with contamination and ensure that the cleanroom operates within specified parameters.

2. Scope

  • Asset ID: CAL-0251
  • Equipment Name/Type: Flow Hood / Airflow Capture Hood / Airflow Hood
  • Department/Area: HVAC / Cleanroom
  • Process Use: Airflow
  • Parameter: Flow
  • Range: 0 – 5000 m3/h
  • Units: m3/h
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
  • Verification: The confirmation that a measurement system is functioning correctly.
  • Adjustment: The process of modifying a measurement instrument to bring it into alignment with a standard.
  • As Found: The condition of the equipment prior to any adjustments made during calibration.
  • As Left: The condition of the equipment after calibration and any adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the established acceptance criteria.
  • Drift: The gradual change in a measurement 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 verification process performed between calibrations to ensure continued 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 and results for compliance.
  • Owner Department: Ensure equipment is available and properly maintained.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up/stabilize as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within specifications.
See also  Flow Meter (PW Loop) (CAL-0080) - 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 across the range of 0 – 5000 m3/h.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the equipment to stabilize as per manufacturer guidelines.
  3. As Found checks and data capture: Record initial readings and observations contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is detected, follow adjustment protocols if allowed; otherwise, escalate to QA.
  5. As Left verification: Record final readings and ensure they meet acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±3% of the measured value.

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

Pass/Fail Logic: If the error falls within ±3%, mark as pass; otherwise, mark as fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and initiate deviation process.
  • 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 for audit purposes.
  • 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 confirmed
  • Leveling checked
  • 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-0251 Flow Hood / Airflow Capture Hood Airflow Hood HVAC Cleanroom Airflow Flow m3/h 0 – 5000 ±3% 365 days External ISO17025
See also  Tablet Press Compression Force Sensor (CAL-0210) - 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 range:

  • Minimum: 0 m3/h
  • 25% of Range: 1250 m3/h
  • 50% of Range: 2500 m3/h
  • 75% of Range: 3750 m3/h
  • Maximum: 5000 m3/h

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 m3/h [TBD] [TBD] [TBD] ±3% [TBD] [TBD] [TBD] [TBD]
1250 m3/h [TBD] [TBD] [TBD] ±3% [TBD] [TBD] [TBD] [TBD]
2500 m3/h [TBD] [TBD] [TBD] ±3% [TBD] [TBD] [TBD] [TBD]
3750 m3/h [TBD] [TBD] [TBD] ±3% [TBD] [TBD] [TBD] [TBD]
5000 m3/h [TBD] [TBD] [TBD] ±3% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Flow Hood is clean and calibrated equipment is available.
  2. Stabilization: Allow the equipment to stabilize for at least 30 minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point and record the values.
  4. Calculating Error: Calculate the error for each test point using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±3%.
  6. Documentation: Complete the results table and ensure all data is recorded accurately.

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.
  • Open a deviation report.
  • Quarantine impacted results window: [TBD].
  • Await QA decision on further actions.

Approvals

Prepared By Reviewed By Approved By
____________________ / Date: ___________ ____________________ / Date: ___________ ____________________ / Date: ___________

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0251 Flow Hood / Airflow Capture Hood HVAC Cleanroom Flow 0 – 5000 m3/h ±3% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the airflow hood as per SOP
  • [ ] Level the equipment properly
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready and accessible

As Found Execution

  • [ ] Set the required flow setpoints
  • [ ] Perform repeat measurements for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Load Cell (Loss-in-weight feeder) (CAL-0013) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] Attach calibration certificate to the logbook
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in the 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
Asset: Flow Hood / Airflow Capture Hood
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

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-0251 Flow Hood / Airflow Capture Hood Airflow Hood HVAC Cleanroom [TBD] [TBD] [TBD] Flow: 0 – 5000 m3/h ±3%

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 (m3/h) Acceptance Criteria Pass/Fail
1 [TBD] ±3% [TBD]
2 [TBD] ±3% [TBD]
3 [TBD] ±3% [TBD]
4 [TBD] ±3% [TBD]
5 [TBD] ±3% [TBD]

As Left Results

Test Point Measured Value (m3/h) Acceptance Criteria Pass/Fail
1 [TBD] ±3% [TBD]
2 [TBD] ±3% [TBD]
3 [TBD] ±3% [TBD]
4 [TBD] ±3% [TBD]
5 [TBD] ±3% [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [TBD]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: __________

Checked by: ______________________ Date: __________

Approved by: _____________________ Date: __________

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