Biosafety Cabinet Air Velocity (CAL-0171) – Calibration Documents

Calibration Documents: Biosafety Cabinet Air Velocity (CAL-0171)

Asset ID CAL-0171
Equipment Biosafety Cabinet Air Velocity
Equipment Type Air Velocity Meter
Department Microbiology
Area/Location BSC Room
Process Use Aseptic work
Parameter Velocity
Units m/s
Range Min 0
Range Max 1
Acceptance Criteria ±0.05 m/s
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 Biosafety Cabinet Air Velocity Meter is performed to ensure accurate measurement of air velocity during aseptic work. This calibration controls risks related to patient safety, batch quality, and data integrity by ensuring that the equipment operates within specified parameters.

2. Scope

  • Asset ID: CAL-0171
  • Equipment Name/Type: Biosafety Cabinet Air Velocity Meter
  • Department/Area: Microbiology / BSC Room
  • Process Use: Aseptic work
  • Parameter: Velocity
  • Range: 0 to 1 m/s
  • Units: m/s
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
  • Verification: The process of confirming that an instrument meets specified requirements.
  • Adjustment: The process of modifying an instrument to bring it into compliance with specifications.
  • 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 measurement output of an instrument 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 check 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 maintain records.
  • QC/QA Reviewer: Review calibration records and ensure 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 equipment to warm up and stabilize as per manufacturer guidelines.
  • Maintain cleanliness of the area and equipment.
  • Check leveling of the equipment.
  • Verify power supply stability.
See also  HPLC System (CAL-0120) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [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 to 1 m/s.
  • Replicate readings: 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the equipment to stabilize in the operating environment.
  3. As Found checks and data capture: Record initial readings before any adjustments.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; otherwise, escalate to QA.
  5. As Left verification: Confirm that the equipment is within specifications after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out and labels are affixed.

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

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.05 m/s

Error calculation formula: Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of Error is less than or equal to 0.05 m/s, then Pass; otherwise, Fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain all calibration certificates in a secure location.
  • 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 warmed up and stabilized
  • 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-0171 Biosafety Cabinet Air Velocity Air Velocity Meter Microbiology BSC Room Aseptic work Velocity m/s 0 – 1 ±0.05 m/s 365 days External ISO17025
See also  Magnetic Stirrer Hotplate Temp (CAL-0160) - Calibration Documents

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Minimum (0 m/s)
  • 25% of Range (0.25 m/s)
  • 50% of Range (0.5 m/s)
  • 75% of Range (0.75 m/s)
  • Maximum (1 m/s)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 m/s [TBD] [TBD] [TBD] ±0.05 m/s [TBD] [TBD] [TBD] [TBD]
0.25 m/s [TBD] [TBD] [TBD] ±0.05 m/s [TBD] [TBD] [TBD] [TBD]
0.5 m/s [TBD] [TBD] [TBD] ±0.05 m/s [TBD] [TBD] [TBD] [TBD]
0.75 m/s [TBD] [TBD] [TBD] ±0.05 m/s [TBD] [TBD] [TBD] [TBD]
1 m/s [TBD] [TBD] [TBD] ±0.05 m/s [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the air velocity meter is clean and calibrated according to the manufacturer’s instructions.
  2. Stabilization: Allow the equipment to stabilize 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 observed value by subtracting the reference value from the observed value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.05 m/s.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the QA department of the out-of-tolerance condition.
  • Open a deviation report to document the incident.
  • Quarantine the 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-0171 Biosafety Cabinet Air Velocity Microbiology BSC Room Velocity 0 to 1 m/s ±0.05 m/s 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the equipment and surrounding area
  • [ ] Ensure the equipment is level
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for documentation

As Found Execution

  • [ ] Set the air velocity meter to specified setpoints
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Chromatography Skid UV Detector (CAL-0312) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel of the OOT condition
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review as per SOP

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 logbook
  • [ ] Obtain reviewer sign-off on calibration documentation
  • [ ] 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
Asset: Biosafety Cabinet Air Velocity
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: [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/Re-test/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-0171 Biosafety Cabinet Air Velocity Air Velocity Meter Microbiology BSC Room [TBD] [TBD] [TBD] Velocity: 0 – 1 m/s ±0.05 m/s

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (m/s) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (m/s) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [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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