Mass Flow Controller (Gas) (CAL-0083) – Calibration Documents

Calibration Documents: Mass Flow Controller (Gas) (CAL-0083)

Asset ID CAL-0083
Equipment Mass Flow Controller (Gas)
Equipment Type Mass Flow Controller
Department Biologics
Area/Location Process Gases
Process Use Gas control
Parameter Flow
Units sccm
Range Min 0
Range Max 5000
Acceptance Criteria ±1%
Calibration Frequency (days) 180
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 Mass Flow Controller (Gas) is performed to ensure accurate flow measurements within the specified range, thereby controlling the gas flow used in biologics processes. This calibration is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity throughout the manufacturing process.

2. Scope

  • Asset ID: CAL-0083
  • Equipment Name/Type: Mass Flow Controller (Gas)
  • Department/Area: Biologics / Process Gases
  • Process Use: Gas control
  • Parameter: Flow
  • Range: 0 – 5000 sccm
  • Units: sccm
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of determining the accuracy of a measurement instrument by comparing it against a standard.
  • Verification: Confirmation that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement 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 verification process conducted 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 in proper condition for calibration.
  • External Service Provider: Conduct external calibrations as per the calibration type.

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 is stable and within required specifications.
See also  CO2 Incubator CO2 Sensor (CAL-0305) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: Ensure all reference standards are within their calibration validity period.
  • Standard ID: [TBD]

8. Calibration Strategy

The calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 and 5000 sccm) and midpoints.
  • 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 Mass Flow Controller to stabilize before taking measurements.
  3. As Found checks and data capture: Record initial readings and document all observations contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is detected, follow the adjustment protocol; if not allowed, escalate to QA.
  5. As Left verification: After adjustments, verify and document the final readings.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1%

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

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease its use.
  • Notification & deviation initiation: Notify relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration following any adjustments.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain records of calibration reports and certificates.
  • e-Records: [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 checked
  • Leveling confirmed
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

See also  Heating Mantle Controller Temp (CAL-0159) - 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-0083 Mass Flow Controller (Gas) Mass Flow Controller Biologics Process Gases Gas control Flow sccm 0 – 5000 ±1% 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 sccm
  • 25% of Range: 1250 sccm
  • 50% of Range: 2500 sccm
  • 75% of Range: 3750 sccm
  • Maximum: 5000 sccm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 sccm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
1250 sccm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
2500 sccm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
3750 sccm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
5000 sccm [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Mass Flow Controller is clean and properly connected to the gas supply.
  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 to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors to the acceptance criteria of ±1%.
  6. Documentation: Record all findings in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

  • Stop use of the Mass Flow Controller immediately.
  • Notify the supervisor and QA 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-0083 Mass Flow Controller (Gas) Biologics Process Gases Flow 0 – 5000 sccm ±1% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up for the specified 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 flow controller to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Inline Conductivity Sensor (PW) (CAL-0094) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review as per SOP

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Field Details
Asset Mass Flow Controller (Gas)
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

Field Details
Last Known In-Tolerance Date [TBD]
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-0083 Mass Flow Controller (Gas) Mass Flow Controller Biologics Process Gases [TBD] [TBD] [TBD] Flow: 0 – 5000 sccm ±1%

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

As Left Results

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